Background About 14.9% of people (9.9 million) registered with primary care practices in England and Wales are prescribed medication for hypertension. However, many do not take their medication as prescribed. To address this problem, we need scalable interventions. Objective To develop a scalable low-cost intervention to support medication adherence in people prescribed medication for hypertension in primary care, and to obtain precise and robust estimates of the effectiveness and cost-effectiveness of the intervention compared with usual care. Design Systematic reviews and meta-analyses; qualitative meta-synthesis; interviews and focus groups; expert consultations; pre-testing study; randomised feasibility trial; randomised controlled trial of effectiveness and cost-effectiveness; economic modelling. Setting and participants Primary care practices in England and Wales. Patients prescribed medication for hypertension with poorly controlled blood pressure. Interventions Very brief intervention delivered by a practice nurse or healthcare assistant followed by a digital intervention (text messaging programme or smartphone app). Main outcome measures Acceptability, feasibility, fidelity and cost of the interventions. Systolic blood pressure. Biochemical and self-reported measures of medication adherence. Results Our systematic reviews showed that both app-based and face-to-face interventions in patients with long-term conditions have a positive effect on medication adherence. The meta-synthesis of published qualitative studies showed that: digital interventions to support medication use were perceived as acceptable and useful; a digital intervention would be more effective if it was personalised and tailored; barriers to using digital interventions included lack of interest, lack of confidence and lack of proficiency and experience in using the technology; digital interventions should be simple, easy to navigate and age-appropriate; patients wanted accurate information on their health condition, potential side effects of medication and health consequences of non-adherence; reminder notifications and a self-monitoring feature were perceived as helpful by some patients; some patients suggested that a digital intervention should enable them to communicate with pharmacies, but practitioners were concerned that this would increase their workload. The interview and focus group study identified several barriers to adherence, including forgetting, unpleasant side effects and reluctance to medicate. A digital intervention to support medication adherence was acceptable to patients if it was user-friendly, the content was tailored to the user, and the privacy of user data was protected. Simple reminder messages for taking medication and reordering prescriptions were considered more useful by patients than those providing information on the benefits of medication or the consequences of non-adherence. Patients preferred to receive feedback on their adherence levels in the form of a simple graph, percentage score or statistic. Practitioners thought that it would be feasible to introduce a digital intervention to patients in a very brief face-to-face consultation. In the pre-testing study, participants reported that the interventions we developed were easy to use and that they would recommend them to others. The feasibility trial showed that the combined intervention was acceptable and that a large cost-effectiveness trial was feasible. The main trial showed no difference between arms in systolic blood pressure or medication adherence at 12-month follow-up. The estimate (95% confidence interval) for the difference in means between arms in self-measured systolic blood pressure at 12 months was −0.61 mmHg (−3.05 to 1.82), p = 0.62 [for intervention vs. control (reference group)]. In the base case analysis, the intervention had a mean incremental cost-effectiveness ratio below the usual willingness-to-pay thresholds in the National Health Service in the United Kingdom. The probability of cost-effectiveness was between 77% and 80% at willingness-to-pay thresholds of £15,000, £20,000 and £30,000 per quality-adjusted life-year, but the confidence intervals are wide and cross zero, indicating some chance that the intervention could be less effective and more costly. Limitations The effectiveness trial was conducted during the COVID-19 pandemic. To reduce the risk of infection, the very brief intervention was delivered by telephone instead of face-to-face, and all study measurements were conducted remotely. This may have led to lower response rates and data quality and lower effectiveness of the intervention. A significant proportion (24%) of participants did not have raised blood pressure at baseline, and self-reported medication adherence was high at baseline, which reduced the possible scope for an intervention effect. Conclusions The findings on effectiveness do not support the commissioning of the intervention in United Kingdom primary care. The cost-effectiveness findings are more equivocal, showing a high probability of being cost-effective at standard United Kingdom willingness-to-pay thresholds, but with some uncertainty. Future work Future research should address the challenge of identifying and recruiting people who are poorly adherent and have raised blood pressure and test the intervention in this group. Variants such as face-to-face delivery, adding a follow-up consultation or a purely digital version could also be investigated. Study registration This study is registered as CRD42017080150; CRD42020164049; ISRCTN12805654; ISRCTN74504989; ISRCTN82013652. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research Programme (NIHR award ref: RP-PG-0615-20013) and is published in full in Programme Grants for Applied Research; Vol. 14, No. 18. See the NIHR Funding and Awards website for further award information. Plain language summary About 15% of people (10 million) registered with primary care practices in England and Wales are prescribed medication for hypertension (high blood pressure). However, many do not take their medication as prescribed, which may harm their health and increases health service costs. To address this problem, we need low-cost interventions that can reach all the people who need them. This research programme aimed to develop a new intervention to support people with poorly controlled blood pressure to take their hypertension medication as prescribed and to assess how well it worked and how much it cost compared with usual care only. The findings would inform a decision on whether to introduce the intervention in primary care practices in the United Kingdom. We used a range of different research methods, including literature reviews, interviews and focus groups, and randomised controlled trials. The intervention we developed has two parts: a very brief intervention delivered by a practice nurse or healthcare assistant by telephone, followed by a digital intervention (individually tailored text messages for up to 420 days or a smartphone app). In the main trial, 537 participants received either the intervention or just usual care and were followed up 12 months later. The intervention was low cost, but it was not effective: the results showed no difference in blood pressure or medication adherence between the two groups at 12 months. Not all participants had raised blood pressure at the start of the study, and many were already taking their medication as prescribed; this may explain why the intervention did not work. The findings suggest that the intervention should not be introduced in United Kingdom primary care practices before showing that it works in patients who do not take their medication as prescribed and have raised blood pressure. Scientific summary Background Hypertension is a global health challenge accounting for 8.5 million deaths worldwide despite the availability of low-cost pharmaceutical treatment. About 14.9% of people (9.9 million) registered with primary care practices in England and Wales are prescribed medication for hypertension. However, many patients with hypertension do not take their medications as prescribed – 42% in the UK according to one study. Non-adherence to antihypertensive medication is associated with increased risk of suboptimal blood pressure (BP) control, complications and all-cause mortality, and increased healthcare costs. Primary care practitioners have an important role in supporting patients to adhere to their prescribed medication. However, they lack time to provide ongoing support for adherence, and their time is expensive. A potential solution is for a practitioner such as a practice nurse to deliver a very brief intervention (VBI) during a consultation and to use a digital intervention such as text messaging or a smartphone app to support subsequent adherence. About 96% of UK adults use a mobile phone, and in 93% of cases, this is a smartphone; the corresponding figures for those aged 65 and above are 88% and 77%. This suggests that digital interventions have the potential to reach the majority of this population. Digital interventions have several other advantages over traditional interventions: they can be fully automated; provide information that is highly tailored to the individual; be interactive; be available at any time; deliver support in real time; deliver support with high fidelity; and be easily updated. Recent meta-analyses have reported promising findings for the effectiveness of nurse-led and digital interventions to improve medication adherence and reduce BP in people with hypertension. The interventions examined in these reviews varied widely in content and delivery, and the digital interventions that have been evaluated to date have not made full use of individual tailoring, interactivity and other features that may increase user engagement and potential effectiveness. Objectives The PAM programme (Programme on Adherence to Medication) aimed to develop and evaluate an intervention to support medication adherence that combines a VBI from a practice nurse or healthcare assistant with a digital intervention (text messaging programme or smartphone app). Such an intervention would be inexpensive to deliver, scalable and potentially cost-effective. The objectives were: To develop a scalable low-cost intervention to support medication adherence in people prescribed treatment for hypertension in primary care. To evaluate the acceptability and feasibility of the intervention and the feasibility of conducting a (cost-)effectiveness trial. To provide precise and robust estimates of the effectiveness and cost-effectiveness of the intervention compared with usual care (UC). To develop an economic model of the cost-effectiveness of medication adherence interventions. To inform a decision on whether to implement the intervention in primary care. Methods The target group is patients in primary care practices in England and Wales who do not take their antihypertensive medication as prescribed and have raised BP. Methods used were: Systematic reviews of randomised controlled trials of app-based (9 trials) and face-to-face interventions (20 trials) to support medication adherence, with random-effects meta-analyses. A meta-synthesis of 30 published qualitative studies of adults taking medication for cardiovascular-related long-term health conditions (e.g. type 2 diabetes, hypertension) and/or healthcare practitioners who treat patients with cardiovascular conditions who were asked about their views and experiences of digital interventions to support medication adherence. Interviews with 11 healthcare practitioners [6 practice nurses, 2 healthcare assistants, 2 practice pharmacists, 1 general practitioner (GP)] and 6 patients, and 4 focus groups, with a total of 14 patients, to gather views on the acceptability and content of digital interventions for medication adherence. Expert consultations with 2 commissioners, 2 academics, 2 nurses, 2 patients and 10 GPs. Participants were e-mailed a description of the proposed intervention, a description of the proposed design of the randomised feasibility study and a link to an online questionnaire that asked their views on the delivery mode and content of the intervention and on the proposed feasibility study. Commissioners were asked about the evidence needed to inform a decision whether to commission the intervention. Pre-testing study of early versions of the digital interventions to assess acceptability. The text messaging intervention was used by 22 patients with hypertension for 28 days, and four of them also used the smartphone app for an additional 28 days. Data were collected by weekly telephone interviews, questionnaires and log files showing how they had used the interventions. Randomised feasibility trial to assess the feasibility and acceptability of the PAM intervention and the feasibility of conducting a large cost-effectiveness trial. Patients with hypertension who had raised BP and were non-adherent to their prescribed medication as indicated by their practice records and practice GP assessment were eligible for the study. One hundred and one eligible patients from nine general practices in the East of England and London were randomised to receiving the PAM intervention (N = 61) or UC only (N = 40). Randomised controlled trial to estimate the effectiveness and cost-effectiveness of the PAM intervention to improve medication adherence and reduce BP compared with UC only, to inform a decision on whether to implement the intervention in primary care (‘main trial’). A total of 573 eligible patients from 57 practices in England and Wales were individually randomised, stratified by practitioner, to the PAM intervention or control (UC only) and followed up at 12 months. The primary outcome was systolic blood pressure (SBP). The analysis was based on 537 participants. Within-trial economic analysis of the cost-effectiveness of the PAM intervention compared with UC alone. The main cost-effectiveness measure was the incremental cost per quality-adjusted life-year (QALY) gained, and the analysis included extensive deterministic and probabilistic sensitivity analyses. Results Systematic reviews The findings from the meta-analysis of app-based interventions showed that, at follow-up, patients in the intervention groups were more likely to self-report adherence to medication than those in the comparator groups [odds ratio 2.12, 95% confidence interval (CI) 1.64 to 2.75, n = 988, p < 0.0005]. None of the behaviour change techniques (BCTs) used in the interventions was significantly associated with intervention effect size. In the meta-analysis of face-to-face interventions, statistically significant pooled effects were found favouring the intervention arm over the control arm for several Medication Event Monitoring System measures of adherence, for example, percentage of prescribed doses taken on time over a period of 3 weeks to 2 months [mean difference (MD) 9.34, 95% CI 4.36 to 14.33, n = 3,667, p = 0.0002]. We also found significant between-arm effects for a self-report measure of adherence (Morisky scale). The impact of BCTs on intervention effectiveness could not be estimated as the analyses were underpowered. Taken together, these reviews supported our proposal to use face-to-face and digital components in the PAM intervention. However, we were unable to identify promising BCTs for potential inclusion in the proposed intervention. Meta-synthesis of previous qualitative studies The main findings from the meta-synthesis of published qualitative studies were: digital interventions to support medication use were perceived as acceptable and useful; a digital intervention would be more effective if it was personalised and tailored; barriers to using digital interventions included lack of interest, lack of confidence and lack of proficiency and experience in using the technology; digital interventions should be simple, easy to navigate and age-appropriate; patients wanted accurate information on their health condition, potential side effects of medication and health consequences of non-adherence; reminder notifications and a self-monitoring feature were perceived as helpful by some patients but unnecessary by others; some patients suggested that a digital intervention should enable them to communicate with pharmacies, but practitioners were concerned that this would increase their workload. Interviews and focus groups with practitioners and patients This study identified several barriers to adherence, including forgetting, unpleasant side effects and reluctance to medicate. A digital intervention to support medication adherence, either via text messages or smartphone app, was acceptable to patients, provided that it was user-friendly, the content was tailored to the user and the privacy of user data was protected. Simple reminder messages for taking medication and reordering prescriptions were considered more useful by patients than those providing information on the benefits of medication or the consequences of non-adherence, which were favoured by practitioners. Rather than messages of encouragement, patients preferred to receive feedback on their adherence levels in the form of a simple graph, percentage score or statistic. All the practitioners thought that it would be feasible to introduce a digital intervention to patients in a very brief face-to-face discussion during a primary care consultation. Expert consultations There was substantial similarity of views between the different stakeholders. They found the concept of a VBI delivered face-to-face by a healthcare practitioner acceptable. However, they felt that it was not feasible to address possible reasons for medication non-adherence in a VBI, and that the intervention should be limited to emphasising the importance of taking medication as prescribed and signposting the patient to a digital intervention. Pre-testing study Participants reported that the interventions were easy to use and that they would recommend them to other people. They were satisfied with the frequency of the messages and the content of the daily reminder and weekly query messages, but they were somewhat less satisfied with the content of the daily non-reminder (advice) messages. The response rate to the query messages was 100%, indicating a high degree of engagement. Randomised feasibility trial All 101 participants had their BP measured at baseline, and the vast majority provided a urine sample for chemical adherence testing. Participants were on average 65.8 years of age, 54% male, with a substantial minority (35%) from the most deprived areas, based on practice postcode. Baseline characteristics were similar in the two arms. At 3-month follow-up, 83% of participants had their BP measured and provided a urine sample, and the percentage was similar in the two arms. Ninety-two per cent of participants randomised to the intervention arm opted to receive text messages, and 8% opted to use the app. Ninety per cent responded to the tailoring questions which were administered digitally. Four intervention participants actively disengaged from the digital intervention by sending a STOP message. Seventy-two per cent continued to use the digital intervention for at least 1 month. The post-trial interviews showed that intervention participants found the intervention to be acceptable. Participants were satisfied with the baseline and follow-up consultations and the study procedures, and there were no concerns among control participants about being randomised to this arm. Practitioners also confirmed that the study procedures and intervention were acceptable. From baseline to follow-up, mean SBP reduced from 146.9 mmHg to 136.9 mmHg in the intervention arm compared with no change in the control arm (adjusted MD 9.2 mmHg, 95% CI 5.7 to 12.6), and biochemically measured adherence increased to a greater extent in the intervention arm than in the control arm, suggesting that the intervention was potentially effective. The findings from this trial showed that the intervention was acceptable to participants and that most offered the digital intervention used it, at least in the short term. The trial procedures were demonstrated to be practicable. Together with the findings on trial uptake and retention rates, this suggested that a large cost-effectiveness trial was feasible. Main trial Baseline characteristics were similar in the two arms. The majority of participants were recruited from practices in the East of England. Similar to the feasibility trial, 56% were male and mean age was 66.5 years. The vast majority categorised themselves as being of White ethnicity, but there was a range of deprivation levels, based on participant home postcode. Mean BP, obtained from practice records before randomisation, was 145/82 mmHg, again similar to the sample in the feasibility trial. Of participants, 75.8% had a BP reading above the accepted cut-off of 140/90 mmHg and 71.7% had a SBP reading above 140. We were, therefore, partially successful in recruiting a sample of participants who had a raised BP even though they were prescribed antihypertensive medication. The estimate (95% CI) for the difference in means between arms in the primary outcome of self-measured SBP at 12 months was −0.61 mmHg (−3.05 to 1.82), p = 0.62 [for intervention vs. control (reference group)]. Thus, the estimated effect was very small, and the detectable effect size of 5 mmHg did not fall within the CI. The estimate for the difference in means between arms for SBP obtained from practice records was 1.04 mmHg (−1.56 to 3.65), p = 0.43. Thus, the intervention appeared to have no effect on SBP. There was also no effect of the intervention on biochemically measured adherence. Of the 392 participants who provided a urine sample at follow-up, 388 (99.0%) were found to have at least one antihypertensive medication (or metabolite) in their urine. Based on the urinalysis, 94.3% of participants were categorised as ‘fully adherent’, 4.8% as ‘partially adherent’ and only 0.9% as ‘non-adherent’. There was no difference in these percentages between trial arms. Self-reported adherence at 12 months was also high, with no difference between trial arms. The mean score on the five-item Medication Adherence Report Scale questionnaire was 23.8 [standard deviation 1.7] out of a maximum score of 25 (based on 387 participants who provided 12-month data on this scale). Of the intervention participants, 212 (77.9%) opted to receive text messages; 60 (22.1%) opted to use the app, and 39 of these became active users. On average, participants were satisfied with the combined intervention (VBI plus digital intervention) and thought that it was acceptable and effective. However, 61.0% used the digital intervention for less than 3 months, with the main reasons being not needing any further support and finding the messages annoying. Economic analysis The total mean intervention cost per patient was £30. In the base case analysis, the intervention was found to be cost-effective compared with UC, with a mean estimated incremental cost-effectiveness ratio (ICER) of £1231 per QALY gained (95% CI −£13,156 to £19,535) and mean incremental net monetary benefit (INMB) of £289 (95% CI −£498 to £1026) at a willingness-to-pay (WTP) threshold of £15,000/QALY. The INMB rose to £400 (95% CI −£643 to £1383) and £621 (95% CI −£933 to £2104) for £20,000/QALY and £30,000/QALY, respectively. The probability that the intervention is cost-effective was between 77% and 80% for these WTP thresholds. Limitations The effectiveness trial was conducted during the COVID-19 pandemic. To reduce the risk of infection, the VBI was delivered by telephone instead of face-to-face, and all study measurements were conducted remotely. This may have led to lower response rates and data quality and lower effectiveness of the intervention. A significant proportion (24%) of participants did not have raised BP at baseline, and self-reported medication adherence was high at baseline, which reduced the possible scope for an intervention effect. Conclusions The combination of a VBI delivered by a practice nurse or healthcare assistant and a digital intervention was acceptable to both patients and practitioners. However, although the feasibility trial showed promising results, the main trial showed no effect of the intervention on medication adherence or SBP at 12 months. The cost-effectiveness findings showed a mean ICER below the usual WTP thresholds, but the CIs are wide and cross zero, indicating some chance that the intervention could be less effective and more costly compared with UC only. The effectiveness findings do not support the commissioning of the intervention in UK primary care. Future research should address the challenge of identifying and recruiting people who are poorly adherent. If it is feasible to recruit patients who are non-adherent to their prescribed antihypertensive medication and have raised BP, the intervention could be tested with the VBI delivered remotely or face-to-face. Variants such as adding a follow-up consultation or testing a purely digital version could also be investigated. The economic model developed for this programme can provide the basis for future economic evaluations of similar interventions across a range of different conditions. Study registration This study is registered as CRD42017080150; CRD42020164049; ISRCTN12805654; ISRCTN74504989; ISRCTN82013652. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research Programme (NIHR award ref: RP-PG-0615-20013) and is published in full in Programme Grants for Applied Research; Vol. 14, No. 18. See the NIHR Funding and Awards website for further award information.

OBJECTIVE:To assess the effectiveness of an interpersonal and digital intervention, BabyBreathe, for maintaining postpartum smoking cessation. DESIGN:Multicentre pragmatic individually randomised controlled trial. SETTING:Community health visiting services in the UK. PARTICIPANTS:887 pregnant women and people who reported quitting smoking in the 12 months before, or during, pregnancy, with abstinence verified by exhaled carbon monoxide readings. A secure web based randomisation sequence, stratified by recruitment hub, partner smoking status, and quit timing (before or during pregnancy), was used to randomise participants (1:1) to receive the intervention or usual care. The trial was unblinded. INTERVENTION:BabyBreathe comprised in-person or remote smoking cessation maintenance interpersonal support at 28-32 weeks' gestation and 10-14 days post partum. The BabyBreathe box, posted at the time of birth notification, contained theory driven advice for cessation maintenance, a sample of nicotine replacement gum, and motivational tools. Tailored motivational and educational text messages were provided. A website and app provided tailored cessation maintenance advice, social support, motivational tools, and gamification. Control was usual postpartum care. MAIN OUTCOME MEASURE:The primary outcome was continuous smoking abstinence, verified by exhaled carbon monoxide concentration (≤7 parts per million (ppm)) 12 months post partum. RESULTS:Between 4 September 2021 and 3 August 2023, 887 participants were randomised: 442 to receive BabyBreathe and 445 to receive usual care. After one post-randomisation exclusion, 886 participants were included in an intention-to-treat analysis. The group difference in smoking abstinence at 12 months post partum was not significant (BabyBreathe 242/441 (54.9%) v usual care 222/445 (49.9%); odds ratio 1.23, 95% confidence interval (CI) 0.94 to 1.60, P=0.13, risk difference 4.8% (-1.7% to 11.2%), and number needed to treat (NNT) 21 (NNT to benefit 8.9 to ∞) and NNT to harm 59). A post hoc per protocol analysis favoured the intervention (BabyBreathe 200/347 (57.6%) v usual care 222/445 (49.9%); adjusted odds ratio 1.36, 95% CI 1.02 to 1.81, P=0.04), risk difference 7.2% (0.3% to 14.1%), and NNT 13.9 (7.1 to 333.3). No trial related adverse incidents occurred. CONCLUSIONS:BabyBreathe did not statistically significantly increase sustained smoking abstinence post partum for people who quit smoking in pregnancy. A post hoc per protocol analysis, including only those who received interpersonal support as intended, showed statistically significantly greater benefit from BabyBreathe over usual care. A focus on fidelity and further targeting of BabyBreathe to groups with lower socioeconomic status may be warranted. TRIAL REGISTRATION:ISRCTN Registry ISRCTN70307341.

Introduction Hypertension is a global health challenge accounting for 8.5 million deaths worldwide despite the availability of low-cost pharmaceutical treatment. About 14.9% of people (9.9 million) registered with primary care practices in England and Wales are prescribed medication for hypertension. However, many patients with hypertension and associated conditions do not take their medications as prescribed. Non-adherence to antihypertensive medication is associated with increased risk of suboptimal blood pressure (BP) control, complications and all-cause mortality, and increased healthcare costs. The Programme on Adherence to Medication (PAM) trial will estimate the effectiveness and cost-effectiveness of a medication adherence intervention in patients prescribed medication for hypertension with poorly controlled blood pressure in primary care. Methods A two-arm multicentre individually randomised controlled parallel group superiority trial recruiting patients prescribed medication for hypertension with poorly controlled BP in primary care practices in England and Wales. The target sample size is 542. Participants in the Intervention group will receive a very brief intervention delivered remotely (by telephone or video call) by a practice nurse or healthcare assistant followed by a digital intervention (text messaging or smartphone app) in addition to usual care; control group participants will receive usual care alone. The primary outcome is systolic BP measured at 12 months. Medication adherence will be measured by chemical adherence testing of urine samples and self-report. An economic evaluation and a process evaluation will be undertaken. Ethics and dissemination The Cambridge East Independent Research Ethics Committee (REC reference 19/EE/0354), the Health Research Authority (HRA) and Health and Care Research Wales (HCRW) approved the trial. The findings will be disseminated to the scientific community, participating practitioners and patients, relevant patient groups and the public using a range of methods, including journal articles, conference presentations, newsletters and the Programme website. Trial registration number The UK’s Clinical Trial Registry ISRCTN82013652

Life story work is a way of supporting children who spend time in out-of-home care to make sense of their experiences. It is highly valued yet poorly evidenced and inconsistently implemented with adolescents aged 12-18 years old. We sought to improve our understandings of the ways in which carers are already supporting what we describe as adolescent-focused low-intensity life story work (AF-LI-LSW) to improve the quality, consistency and availability of this support. We collected data from seventy-eight participants (adolescents, carers and social care professionals) from eight English Local Authorities. Using a participatory realist evaluation, we analysed qualitative and quantitative data to develop and test our understandings of AF-LI-LSW. We developed seven principles indicating that AF-LI-LSW is likely to be optimal when: it is flexible and person-centred; starts early; begins in the present; provides future storytelling prompts; adolescents are encouraged to participate; focusses on everyday life and when training and support is available. Participants' experiences were characterized by several dilemmas. The need to offer (and desire for care-experienced adolescents to enact) participation choices whilst acting in the best interest of adolescents in current and possible future contexts. Our findings provide guidance for carers, adolescents and children's out-of-home care more broadly. Interventions aimed at improving the well-being of care-experienced adolescents often lack guidance on how they can be best implemented in practice. Life story work (LSW) is one such intervention. LSW is used to promote self-identity by supporting children and adolescents to re-frame and understand their past experiences. However, LSW is poorly evidenced, often aimed at younger children and deemed not suitable for many adolescents. Adolescent-focused low-intensity life story work (AF-LI-LSW) involves caring adults supporting adolescents in their care to record memories and/or collect memorabilia from their lives, using these as conversational prompts to facilitate adolescents' understanding of their life experiences. Implementation of this approach varies in practice, with limited guidance available to support caring adults. In this paper we report on an evaluation of how, why, when and for whom such an approach may be delivered to better support care-experienced adolescents. Lived experience co-researchers supported the collection and analysis of data from seventy-eight participants (adolescents aged 12-18 years old, carers and social care professionals). This work developed seven principles for how to optimally deliver AF-LI-LSW within real-world settings and underscored the need to better support carers putting these into practice.

PURPOSE:Community behaviour change interventions are a promising strategy for addressing unhealthy eating and physical activity behaviours in underserved populations. This review explores these interventions' characteristics by focusing on behaviour change techniques, evaluates their behaviour change effectiveness and examines participant experiences. METHODS:A mixed-methods rapid review was conducted. Five databases and the grey literature were searched and supplemented by hand searching. Results were screened, assessed for methodological quality and data extracted using the Behaviour Change Techniques Ontology. A convergent segregated approach was used to synthesize the results. RESULTS:Twenty-one studies were included. Commonly used behaviour change techniques were social support, guidance on how to perform the behaviour and monitoring. Intervention effects on healthy eating and physical activity behaviour change were small, but outcomes that measured influences on behaviour change (e.g., social support) improved. Participants reported largely positive experiences, mostly attributed to the intervention's tailoring to the target population's contexts and the engagement and expertise of those who delivered the intervention. CONCLUSIONS:Evidence of direct behaviour change remains limited; there is stronger evidence for improvements in factors that influence behaviour change. Qualitative evidence highlights the value of tailoring interventions to participants' lives and using relatable, knowledgeable sources for delivery. This could enhance engagement and contribute to improved outcomes over time. Further research is needed on how contextual tailoring is implemented and how the characteristics of those delivering interventions influence effectiveness and experience. Findings support the potential of community-centred approaches, but long-term evaluations in underserved contexts are needed.

BACKGROUND:Recruiting older adults to public health interventions is challenging, and underrepresentation can have important consequences for research outcomes and scalability. This paper reports the process of recruiting participants and the effectiveness of strategies employed in the "Walk with Me" study, a physical activity intervention targeting older adults in areas of socioeconomic disadvantage in Northern Ireland. METHODS:Thirty-eight community organizations and 10 general practices located in areas of socioeconomic disadvantage were involved in recruiting activity over an 18-month period. Recruitment methods included letters from general practices and the distribution of study information through local community organizations. Demographic information about participants and how they heard about the study were collected as part of baseline data collection for the trial. RESULTS:Of the 364 participants recruited, information on recruitment source was available from 355 (124 males, 230 females, and 1 who did not identify as either male or female). Of these, 328 (92.4%) self-reported that they were recruited via a letter from their general practitioner, and 27 (7.6%) reported being recruited from other sources. Postintervention focus groups with 30 participants identified their reasons for participating included a perception that their general practitioner had selected them personally, it provided an opportunity for a health check as access to a general practitioner can be difficult, and they were encouraged to participate by family members. CONCLUSIONS:Recruitment to community-based interventions requires partnerships with general practices to ensure successful completion. Findings provide insight into the recruitment of older adults in a community-based physical activity intervention.

Objectives: Behaviour change theories have extensively been used in health behaviour change interventions and their programme theories. However, they are rarely evaluated in randomized field studies. The Let's Move It intervention targeted various psychosocial constructs to increase adolescents' physical activity. A theory-based process evaluation aiming to illuminate the trial findings as well as to test the programme theory used is conducted. Specifically, we investigate whether the intervention influenced the theorized determinants of change immediately post-intervention and after 1 year, and whether these determinants were associated with changes in physical activity. Design: A cluster-randomized controlled trial (n = 1166). Methods: We measured theorized determinants with self-report, and physical activity (PA) with accelerometry and self-report. The effects are evaluated with repeated measures ANOVA and regression models. Results: No changes were detected in most theorized determinants but intervention arm reported higher enactment of behaviour change techniques used during intervention immediately post-intervention and lower descriptive norms for PA throughout. Autonomous motivation was associated with PA immediately post-intervention. Conclusions: The lack of intervention effects may be due to many factors, for example insensitive measures, ceiling effects. However, reporting these null effects advances understanding of behaviour change processes. We introduce methodologic possibilities for future intervention programme theory evaluation efforts.

Abstract Introduction Medication reviews are a widely implemented intervention to support patients who are prescribed multiple medicines or those with complex medication regimens. The more medicines a patient takes, the higher the chance of them experiencing harmful effects. Despite the extensive use of medication reviews, the proportion of patients who experience poor medicines outcomes such as adverse drug reactions and hospitalisations has not altered significantly in ten years. Pharmacists have been introduced to general practice to help to improve patient access to medication reviews. Aim The aim of this study was to explore pharmacists’, patients’, and general practitioners’ (GPs’) opinions and experience of medication reviews in general practice. Methods We held one focus group with patients and one with pharmacists. As the two GPs were unable to attend the focus group with the pharmacists, they were individually interviewed. Purposive sampling was used to select participants with a range of ethnicity, gender, age, and geographical mix. Reflexive thematic analysis of the focus group and interview transcripts was undertaken by one researcher (MC) to identify themes.[1] Results Seven patients, five pharmacists, and two general practitioners participated in this study. Two main themes were generated. Theme one: preparing for the review. Subtheme one: time to prepare. Patients require advance notice of their review so they can be prepared with queries. Pharmacists need sufficient time to familiarise themselves with the patient’s history and perform the necessary clinical checks. Subtheme two: education about medication reviews. Some patients do not understand the purpose or process of a medication review and can be reticent to engage. Subtheme three: suitability of appointments. Longer face-to-face appointments usually benefit patients with complex medication regimens, or patients with communication difficulties. Patients who have simple regimens or are happy with their medicines may be content with a telephone or online review. Theme two: conducting the medication review. Subtheme one: establish the aim of the review. Patients present for medication reviews for different reasons (e.g., a clinical issue has been identified, patients meet defined criteria or take specific medicines); therefore, the aim of the review should be established at the beginning. Subtheme two: involve and engage the patient. Patients want to feel that they have been listened to and supported during the medication review. Patients want more opportunities to ask questions and/or raise their concerns in the review. Subtheme three: defined but flexible process for the review. Pharmacists and GPs acknowledged the use of templates and guidance to deliver medication reviews, but stressed the importance of tailoring the medication review to meet the needs of the patient. Conclusion Whilst recruitment was challenging, the variety of participants provided a multi-perspective view of medication reviews and a rich source of data. GPs interviews provided a good source of data, but it is possible that different sub-themes may have been generated from integrated discussions. The themes identified provide an outline of the implementation of pharmacist-led medication reviews in general practice. These can be used to support future work to optimise medication reviews in primary care. References 1. Braun, V and Clarke, V. Thematic Analysis: A Practical Guide. Sage; 2022.

OBJECTIVES:Women in the criminal justice system and women who have been subject to domestic abuse are at high risk of cancer but underrepresented in health promotion research. We aimed to co-produce, pilot and evaluate a health promoting programme delivered on group walks. DESIGN:A programme co-produced by women, based on motivational interviewing, created the opportunity for supportive conversations about cancer prevention. METHODS:Programme development in two workshops with women with lived experience using authentic vignettes to prompt help-seeking conversations. A small pilot and a qualitative evaluation was done using framework analysis. RESULTS:The programme appeared acceptable to women and the walk leaders. Women felt included and found it a safe space for sensitive conversations. They appeared empowered and more confident to seek help. Walk leaders expressed confidence in delivering this informal programme, which used prompts rather than delivering didactic training. CONCLUSION:Cancer prevention for high-risk groups can be delivered in a personalised and novel way by creating informal opportunities for supportive conversations about cancer prevention. Careful co-production of the programme of walks with women, using scenarios and quotes that were authentic vignettes, ensured that these came directly from the women's lived experience and enabled women to talk about change. Our findings indicate that this approach was practical, relevant and acceptable to them with some evidence of women feeling empowered to make informed decisions about their health. We recommend that future cancer prevention programmes for underrepresented groups take an asset-based approach by utilising pre-existing community organisations to increase reach and sustainability. PATIENT AND PUBLIC INVOLVEMENT:Women with lived experience co-designed and tested the programme. Provisional findings were fed back to the women and the women's organisation that partnered with this research.

Abstract Background and Purpose Development of effective physical activity interventions for older adults is important in eliciting positive health and well-being outcomes. ‘Walk with Me’ is a community-based, peer-led walking intervention aimed at increasing moderate-vigorous physical activity in older adults living in socio-economically disadvantaged areas. This qualitative study aims to understand participant and mentor experiences of the ‘Walk with Me’ intervention. Methods Six participant and four peer-mentor focus groups were conducted immediately post-intervention using semi-structured topic guides. Participants and mentors, all aged 60 years or above, were purposely sampled to reflect the wider demographic of the ‘Walk with Me’ intervention. Sessions were audio recorded, transcribed verbatim and validated for accuracy by another author. A framework analysis approach is currently being used for coding transcripts. Analysis will be conducted in the following stages: familiarisation with the audio recordings, coding of the transcripts, development of an analytical framework, application of the framework, charting and interpretation of the data. Analysis will explore the similarities and differences in responses across demographic factors. Preliminary results A total of 30 participants (19 females and 11 males) and 16 peer-mentors (nine females and seven males) participated in the focus groups. Each focus group session was comprised of between three and nine individuals, and lasted between 35 and 59 minutes. A preliminary analysis of three participant focus group transcripts suggest that the among the key mediators and moderators of walking in this intervention are social support, feelings of accountability, improved self-efficacy, raised awareness and the physical environment. There are indications that behavioural change techniques of goal setting, feedback and monitoring, problem-solving (overcoming barriers) and action planning may have positively contributed to engagement. Perceived barriers and facilitators to participation, perceived outcomes and perceptions of the implementation of key intervention components have also been provisionally identified. Preliminary Conclusions The findings are likely to highlight considerations for implementation, the role of key mechanisms and the contextual factors that may have influenced delivery, receipt and enactment of a peer-led walking intervention. It is expected that findings will help propose refinements to the intervention logic model and recommendations that can inform future studies.

Abstract Background Despite an urgent need for multi-domain lifestyle interventions to reduce dementia risk, there is a lack of interventions which are informed by theory- and evidence-based behaviour change strategies, and no interventions in this domain have investigated the feasibility or effectiveness of behaviour change maintenance. We tested the feasibility, acceptability and cognitive effects of a personalised theory-based 24-week intervention to improve Mediterranean diet (MD) adherence alone, or in combination with physical activity (PA), in older-adults at risk of dementia, defined using a cardiovascular risk score. Methods Participants (n = 104, 74% female, 57–76 years) were randomised to three parallel intervention arms: (1) control, (2) MD, or (3) MD + PA for 24 weeks and invited to an optional 24-week follow-up period with no active intervention. Behaviour change was supported using personalised targets, a web-based intervention, group sessions and food provision. The primary outcome was behaviour change (MD adherence and PA levels), and the secondary outcomes included feasibility and acceptability, cognitive function, cardiometabolic health (BMI and 24-h ambulatory blood pressure) and process measures. Results The intervention was feasible and acceptable with the intended number of participants completing the study. Participant engagement with group sessions and food provision components was high. There was improved MD adherence in the two MD groups compared with control at 24 weeks (3.7 points on a 14-point scale (95% CI 2.9, 4.5) and 48 weeks (2.7 points (95% CI 1.6, 3.7)). The intervention did not significantly change objectively measured PA. Improvements in general cognition (0.22 (95% CI 0.05, 0.35), memory (0.31 (95% CI 0.10, 0.51) and select cardiovascular outcomes captured as underpinning physiological mechanisms were observed in the MD groups at 24 weeks. Conclusions The intervention was successful in initiating and maintaining dietary behaviour change for up to 12 months which resulted in cognitive benefits. It provides a framework for future complex behaviour change interventions with a range of health and well-being endpoints. Trial registration ClinicalTrials.gov NCT03673722.

Objectives To describe the systematic development of a physiotherapist led group behaviour change intervention targeting physical activity and sedentary behaviour in individuals who have undergone bariatric surgery. Study design Intervention development including evidence synthesis, qualitative research and mapping of intervention components, using the 2008 MRC framework for complex interventions. MethodsWe conducted a systematic review to identify the evidence for promising interventions and components to increase physical activity and reduce sedentary behaviour following bariatric surgery. We also conducted primary qualitative research exploring these behaviours with three key stakeholder groups: patients, clinicians and commissioners. We selected two contemporary behaviour change frameworks to inform intervention development and developed a conceptual matrix in which intervention objectives were defined to inform selection of appropriate behaviour change techniques, proposed mechanisms of action(s), and mode of delivery. We also developed two intervention handbooks for participants and facilitators to support delivery and receipt of the intervention. Results We have developed a behaviour change intervention targeting physical activity and sedentary behaviour in patients following bariatric surgery. Eight intervention objectives were defined and mapped to the Behaviour Change Wheel and Theoretical Domains Framework. We identified what the intervention must be able to do (intervention functions), behaviour change techniques that could be used to achieve this, the proposed mechanism of action, and mode of delivery. This intervention will be subject to a feasibility study, with the intervention delivered online over a six-week period to participants who have had bariatric surgery within the previous five years.

Introduction Pharmacist-led medication reviews are an established intervention to support patients prescribed multiple medicines or with complex medication regimes. For this systematic review, a medication review was defined as ‘a consultation between a pharmacist and a patient to review the patient’s total medicines use with a view to improve patient health outcomes and minimise medicines-related problems’. It is not known how varying approaches to medication reviews lead to different outcomes. Aim To explore the common themes associated with positive outcomes from pharmacist-led medication reviews. Method Randomised controlled trials of pharmacist-led medication reviews in adults aged 18 years and over were included. The search terms used in MEDLINE, EMBASE and Web of Science databases were “medication review”, “pharmacist”, “randomised controlled trial” and their synonyms, time filter 2015 to September 2023. Studies published before 2015 were identified from a previous systematic review. Risk of bias was assessed using the Cochrane risk of bias 2 tool. Descriptions of medication reviews’ components, implementation and outcomes were narratively synthesised to draw out common themes. Results are presented in tables. Results Sixty-eight papers describing 50 studies met the inclusion criteria. Common themes that emerged from synthesis include collaborative working which may help reduce medicines-related problems and the number of medicines prescribed; patient involvement in goal setting and action planning which may improve patients’ ability to take medicines as prescribed and help them achieve their treatment goals; additional support and follow-up, which may lead to improved blood pressure, diabetes control, quality of life and a reduction of medicines-related problems. Conclusion This systematic review identified common themes and components, for example, goal setting, action planning, additional support and follow-up, that may influence outcomes of pharmacist-led medication reviews. Researchers, health professionals and commissioners could use these for a comprehensive evaluation of medication review implementation. PROSPERO registration number CRD42020173907.

IntroductionPhysical inactivity and sedentary behaviour are linked to increased risk of cardiovascular disease, infections and dementia, as well as placing a significant economic burden on healthcare systems. The implementation of COVID-19 pandemic lockdown measures aimed at reducing virus transmission posed challenges to the opportunity to be physically active. This study investigates how the first UK COVID-19 lockdown affected objectively measured physical activity in older adults at higher risk of cardiovascular disease.MethodsWe studied 48 individuals aged 55-74 years (81.3% female) with self-reported PA levels < 90 min/week and a QRISK2 score ≥ 10 (indicative of a ≥ 10% risk of a major cardiovascular event in the next 10 years) without mild cognitive impairment or dementia. Physical activity data was collected using objective wrist-based activity monitors and analysed across three time periods, usual activity (pre-pandemic), the precautionary phase when the UK began advising on limiting social contact and finally during the first UK lockdown period was collected (27 January 2020 and 07 June 2020). Data was analysed using linear mixed effects model was used to investigate PA levels over the measured 12-week period. Effects of BMI, age, deprivation score and baseline PA levels on PA across the three measurement periods were also examined. Focus-group and individual interviews were conducted, and data were thematically analysed.ResultsAverage daily step count (−34% lower, p < 0.001) and active energy expenditure (−26% lower, p < 0.001) were significantly lower during the precautionary period compared with the usual activity period. Physical activity remained low during the UK lockdown period. Participants with a lower BMI engaged in significantly more (+45% higher daily steps p < 0.001) physical activity and those over 70 years old were more physically active than those under 70 years across the 12-week period (+23% higher daily steps p < 0.007). The risk of COVID-19 infection and restrictions because of lockdown measures meant some individuals had to find alternative methods to staying physical active. Participants described a lack of access to facilities and concerns over health related to COVID-19 as barriers to engaging in physical activity during lockdown. For some, this resulted in a shift towards less structured activities such as gardening or going for a walk.DiscussionThe data presented shows that lockdown measures during the COVID-19 pandemic significantly reduced physical activity among older individuals at risk of cardiovascular disease, particularly those with a higher body mass index. To support this population group in staying active during future lockdowns, a multifaceted strategy is needed, emphasizing psychosocial benefits and home-based physical activity. The MedEx-UK study was pre-registered with ClinicalTrials.gov (NCT03673722).

Introduction Physical activity (PA) is protective against type 2 diabetes (T2D). However, data on pragmatic long-term interventions to reduce the risk of developing T2D via increased PA are lacking. This study investigated the cost-effectiveness of a pragmatic PA intervention in a multiethnic population at high risk of T2D.Materials and methods We adapted the School for Public Health Research diabetes prevention model, using the PROPELS trial data and analyses of the NAVIGATOR trial. Lifetime costs, lifetime quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) were calculated for each intervention (Walking Away (WA) and Walking Away Plus (WA+)) versus usual care and compared with National Institute for Health and Care Excellence’s willingness-to-pay of £20 000–£30 000 per QALY gained. We conducted scenario analyses on the outcomes of the PROPELS trial data and a threshold analysis to determine the change in step count that would be needed for the interventions to be cost-effective.Results Estimated lifetime costs for usual care, WA, and WA+ were £22 598, £23 018, and £22 945, respectively. Estimated QALYs were 9.323, 9.312, and 9.330, respectively. WA+ was estimated to be more effective and cheaper than WA. WA+ had an ICER of £49 273 per QALY gained versus usual care. In none of our scenario analyses did either WA or WA+ have an ICER below £20 000 per QALY gained. Our threshold analysis suggested that a PA intervention costing the same as WA+ would have an ICER below £20 000/QALY if it were to achieve an increase in step count of 500 steps per day which was 100% maintained at 4 years.Conclusions We found that neither WA nor WA+ was cost-effective at a limit of £20 000 per QALY gained. Our threshold analysis showed that interventions to increase step count can be cost-effective at this limit if they achieve greater long-term maintenance of effect.Trial Registration number ISRCTN registration: ISRCTN83465245: The PRomotion Of Physical activity through structuredEducation with differing Levels of ongoing Support for those with pre-diabetes (PROPELS)https://doi.org/10.1186/ISRCTN83465245.

Background: The proportion of the population aged 65 years or older is increasing. Typically, physical activity and health decline with age, which is why action to promote active ageing is a major public health priority, particularly due to health inequalities in older adults. The aim of this study is to assess the effectiveness and cost-effectiveness of the Walk with Me peer-led walking intervention for older adults. Methods: This study is a two-arm, assessor-blind, randomised controlled trial. The intervention is a 12-week peer-led walking intervention based on social cognitive theory. Participants in the control group will receive information on active ageing and healthy nutrition. The study will target 348 community-dwelling older adults, aged 60 years or over living in areas of socio-economic disadvantage communities. Trained peer mentors will deliver the intervention. The primary outcome will be a mean between-group change in moderate-to-vigorous physical activity at 12 months from baseline, measured using an Actigraph accelerometer. Secondary outcomes will include quality of life, mental wellbeing, blood pressure, BMI and waist circumference. An embedded process evaluation will involve focus groups and participant diaries. Discussion: Evidence-based, cost-effective interventions to promote physical activity in older adults living in socio-economically disadvantaged communities are needed to address health inequalities.

BACKGROUND:Medication reviews aim to support patients who take medicines, and they are often led by pharmacists. There are different types of medication reviews undertaken in various settings. Previous research undertaken in 2015 found mixed evidence that medication reviews in community settings improve clinical outcomes, but further work needs to be undertaken to establish their impact on patient-orientated and economic outcomes. AIM:This scoping review aims to explore the extent and range of systematic reviews of medication reviews conducted by pharmacists, the nature of the intervention, the evidence for effectiveness, and reported research gaps. METHOD:Systematic reviews were included irrespective of participants, settings or outcomes and were excluded if pharmacists did not lead the delivery of the included interventions. Data extracted included the design of included studies, population, setting, main results, description of interventions, and future research recommendations. RESULTS:We identified twenty-four systematic reviews that reported that medication review interventions were diverse, and their nature was often poorly described. Two high-quality reviews reported that there was evidence of no effect on mortality; of these one reported an improvement in medicines-related problems (all studies reported an increase of identified problems), and another a reduction in hospital readmissions (Risk ratio 0.93 [95% CI 0.89, 0.98]). Other lower-quality reviews reported evidence supporting intervention effectiveness for some clinical outcomes (odds ratio: achieving diabetes control = 3.11 95% prediction intervals (PI), 1.48-6.52, achieving blood pressure target = 2.73, 95% PI, 1.05-7.083.50). CONCLUSION:There is mixed evidence of effectiveness for medication reviews across settings and patient populations. There is limited data about the implementation of medication reviews, therefore is difficult to ascertain which components of the intervention lead to improved outcomes. As medication reviews are widely implemented in practice, further research should explore the nature of the interventions, linking the components of these to outcomes.

Abstract Background and purpose Development of effective physical activity interventions for older adults is important in eliciting positive health and well-being outcomes. Process evaluations of interventions are important in understanding implementation, mechanisms of impact and contextual factors that may influence these outcomes. However, it is unclear whether process evaluation frameworks are rigourously applied to physical activity interventions with older adults, particularly in relation to Medical Research Council (MRC) process evaluation guidance. This study aimed to systematically review the application and reporting of process evaluations of physical activity interventions for older adults against MRC process evaluation guidance. Methods MEDLINE, EMBASE, CINAHL, AMED, PsycINFO, SPORTDiscus, OpenGrey, ProQuest Dissertations & Theses Database (PQDT) databases were searched. Process evaluation studies of physical activity interventions for older adults which measured at least two key MRC domains of implementation, mechanisms of impact and context were included. Two authors completed independent screening of title, abstract and full-text articles. A bespoke coding frame was developed to map and extract methods and findings on to key MRC process evaluation domains. Given the qualitative nature of the data, a narrative synthesis approach was undertaken. Results 17,002 studies were identified in the search, of which 27 were included. After mapping the methods of included studies against key domains of the coding framework; 21 assessed implementation, 27 assessed mechanisms of impact and 12 assessed context. 16 interventions reported the use of a process evaluation framework, 15 cited the use of a theoretical behavioural model and 7 reported the application of a logic model in intervention design. There were substantial differences in both the extent and quality of process evaluation methods. Such disparities were shaped in part by variations in the application of theoretical models and frameworks. Conclusions When mapping the included studies against MRC process evaluation guidelines, this review presented inconsistencies in how process evaluations have been reported and findings suggest a lack of methodological rigour. Findings highlight the need to extend the scope and quality of process evaluations of physical activity interventions for older adults.

Abstract Background Charcot neuroarthropathy is a complication of peripheral neuropathy associated with diabetes which most frequently affects the lower limb. It can cause fractures and dislocations within the foot, which may progress to deformity and ulceration. Recommended treatment is immobilisation and offloading, with a below knee non-removable cast or boot. Duration of treatment varies from six months to more than 1 year. Small observational studies suggest that repeated assessment with magnetic resonance imaging improves decision-making about when to stop treatment, but this has not been tested in clinical trials. This study aims to explore the feasibility of using serial magnetic resonance imaging without contrast in the monitoring of Charcot neuroarthropathy to reduce duration of immobilisation of the foot. A nested qualitative study aims to explore participants’ lived experience of Charcot neuroarthropathy and of taking part in the feasibility study. Methods We will undertake a two-arm, open study and randomise 60 people with a suspected or confirmed diagnosis of Charcot neuroarthropathy from five NHS, secondary care multidisciplinary Diabetic Foot Clinics across England. Participants will be randomised 1:1 to receive magnetic resonance imaging at baseline and remission up to 12 months, with repeated foot temperature measurements and X-rays (standard care plus), or standard care plus with additional three-monthly magnetic resonance imaging until remission up to 12 months (intervention). Time to confirmed remission of Charcot neuroarthropathy with off-loading treatment (days) and its variance will be used to inform sample size in a full-scale trial. We will look for opportunities to improve the protocols for monitoring techniques and the clinical, patient-centred and health economic measures used in a future study. For the nested qualitative study, we will invite a purposive sample of 10–14 people able to offer maximally varying experiences from the feasibility study to take part in semi-structured interviews to be analysed using thematic analysis. Discussion The study will inform the decision whether to proceed to a full-scale trial. It will also allow deeper understanding of the lived experience of Charcot neuroarthropathy, and factors that contribute to engagement in management and contribute to the development of more effective patient-centred strategies. Trial registration ISRCTN, ISRCTN74101606 . Registered on 6 November 2017.

AbstractObjectivesDuring COVID‐19 the UK general population has been given strong messages to stay at home. Concurrently unprecedented changes occurred in healthcare access with moves to remote/triage systems. Data have shown that the number of people accessing healthcare services decreased and there are significant concerns that the pandemic has negatively affected help‐seeking for serious conditions, with potentially increased morbidity and mortality. An understanding of help‐seeking is urgently needed to inform public campaigns. We aimed to develop an in‐depth, theory‐based understanding of how, when and why people sought help for potentially serious symptoms (e.g., related to major cardiovascular events or cancer diagnoses) during the pandemic, and what influenced their decisions.DesignQualitative semi‐structured interviews.MethodsWe interviewed 25 adults recruited through a targeted social media campaign. Interviews were conducted via telephone or online platform. Our topic guide was informed by the Model of Pathways to Treatment and the Capability‐Opportunity‐Motivation‐Behaviour model.ResultsThe analysis identified four main themes: Delay in recognition, Holding on to concerns, Weighing it up and Long‐term impacts. Multiple societal and environmental factors influenced participants' help‐seeking and motivation, capability and opportunity to seek help, with long‐term impacts on well‐being and future help‐seeking.ConclusionsThere is a need for clear guidance about pathways to raise concerns about symptoms and gain advice while usual healthcare contacts are paused or stopped. Recommendations for future interventions to support help‐seeking during pandemics include clearer messaging, co‐produced with end‐users, on when, where and how to seek help.