BACKGROUND:An escalating prevalence of older adults living longer with chronic conditions challenges the health care workforce. Innovative web-based services, such as those based on the Epital Care Model (ECM), may help address these challenges, though their effects remain undocumented. OBJECTIVE:The objectives of this study are to investigate whether telehealth services provided by an ECM response and coordination center, complementary to usual care provided by general practitioners (GPs), affect the participants' mental well-being and use of health care services as primary outcomes, and social activities and mobility as a secondary outcome. METHODS:Using a pragmatic, modified, stepped wedged, nonblinded design, 184 people living with chronic obstructive pulmonary disease, diagnosed in accordance with the GOLD (Global Initiative for Chronic Obstructive Lung Disease) guidelines, were, for logistic and resource reasons, randomized over a period of 10 months, within blocks of up to ten participants and at four geographically distinct locations, into either an ECM-based complementary telehealth service (ECTHS), manned by certified nonprofessional staff, or usual care provided by GPs and other health care services. All baseline parameters were collected in person, whereas all follow-up data were based on data from the participants' health records and telephone interviews at 8 months (T1) and 12 months (T2). Mental well-being was assessed by the World Health Organization-5 Well-Being Index (WHO-5), using an independent 2-sample t test for comparison between groups and a dependent 2-sample t test for comparison between T0 and T1 and T2, respectively, within the two groups. Health care service usage and participants' social activity and mobility were assessed and compared using Poisson regression. RESULTS:In an intention-to-treat analysis, there were no differences in WHO-5 score within or between groups, whereas a difference was found at T2 in a per protocol analysis (mean 68.68, SD 17.40 in ECTHS vs 59.70, SD 19.51 in usual care; P=.01). Estimates of the Poisson regression were for chronic obstructive pulmonary disease related contacts to health care services at T2 for hospital admissions (0.51; P=.04), out-of-office services (0.49; P=.09), outpatient clinics (0.49; P=.02), and visits at GP (0.25; P<.001), demonstrating a reduction in usage between 49% and 75% after adjustment for age, GOLD risk score, risk time and comorbidities. In addition, at both T1 and T2, there was an increase in participation in cultural events and travel activities abroad, with T2 estimates of 1.73 (P<.001) and 2.50 (P=.002), respectively, demonstrating an increase of 73% and 150%, respectively. CONCLUSIONS:These results contribute to a new perspective on how health care services can be organized to reduce health care usage and increase social activity and mobility based on an ECTHS manned with nonprofessional certified staff. TRIAL REGISTRATION:ClinicalTrials.gov NCT06988566, https://clinicaltrials.gov/study/NCT06988566 (retrospectively registered).

In many medical studies, the outcome measure (such as quality of life, QOL) for some study participants becomes informatively truncated (censored, missing, or unobserved) due to death or other forms of dropout, creating a nonignorable missing data problem. In such cases, the use of a composite outcome or imputation methods that fill in unmeasurable QOL values for those who died rely on strong and untestable assumptions and may be conceptually unappealing to certain stakeholders when estimating a treatment effect. The survivor average causal effect (SACE) is an alternative causal estimand that surmounts some of these issues. While principal stratification has been applied to estimate the SACE in individually randomized trials, methods for estimating the SACE in cluster-randomized trials are currently limited. To address this gap, we develop a mixed model approach along with an expectation-maximization algorithm to estimate the SACE in cluster-randomized trials. We model the continuous outcome measure with a random intercept to account for intracluster correlations due to cluster-level randomization, and model the principal strata membership both with and without a random intercept. In simulations, we compare the performance of our approaches with an existing fixed-effects approach to illustrate the importance of accounting for clustering in cluster-randomized trials. The methodology is then illustrated using a cluster-randomized trial of telecare and assistive technology on health-related QOL in the elderly.

Many healthcare systems confront considerable strain attributable to an escalating prevalence of older adults living longer leading to an increased number of people with chronic conditions. Concomitantly the numbers of trained professionals in the healthcare workforce is not keeping up with the increased numbers of people with chronic conditions. In this context, increased digitalization is considered one way to mitigate many of the challenges, but it remains to be documented whether this is of benefit to COPD patients. The Epital Care Model (ECM) constitutes a proactive and data-centric treatment paradigm that leverages patient-reported outcome data and 24/7 telehealth service to facilitate early detection of deteriorating conditions among patients with chronic diseases (1). This approach aims to reduce and address exacerbations early, thereby averting the need for extensive and resource-intensive interventions. It is noteworthy that the Epital frontline service is delivered by trained and certified staff consisting of students from health educations and not by health care professionals. This clinical controlled trial was conducted to investigate the impact of the virtual component of the ECM framework in COPD on healthcare resource utilization and participants mental wellbeing and social activities. A pragmatic step-wedged design was employed, involving the random allocation of 184 patients into either an intervention group (n=92) or a control group (n=92), with equitable distribution across four general practice clinics in Denmark. Participants were examined at an 8-month (T1) follow-up and 12-month (T2) follow-up. Healthcare service utilisation and participants’ social activity were assessed and compared using Poisson regression. Mental wellbeing was assessed by comparing the scores on the WHO-5 wellbeing index using an unpaired t-test. A significant reduction of healthcare utilization associated with COPD was found in the intervention group at T2, with reduced hospital admissions (56%), general practitioner visits (78%), on-call doctor consultations (73%), emergency room visits (49% reduction), and outpatient attendances (60% reduction) compared to the control group. Further, there was a significant increase in social activities (p< 0.01) and travel activities abroad (p< 0.01) at T2 in the intervention group, but no difference was found in well-being (WHO-5 index) between the two groups The study highlights the value of the ECM virtual care model in COPD management, offering a potential solution to healthcare workforce shortages and resource constraints as it leads to both a significantly reduced use of healthcare services and at the same time introduces a new kind of workforce to complement the existing workforce. Further research using this model in other chronic conditions and other healthcare systems is warranted based on these findings. No trial registration has been performed. The protocol is available from: https://epital.com/temokap-protokol-2/

Objective To explore the cost-effectiveness of a web-based support tool for parents of children with Juvenile idiopathic arthritis.Methods A multi-centred randomized controlled trial was conducted in paediatric rheumatology centres in England. The WebParC intervention consisted of online information about JIA and its treatment and a toolkit using cognitive-behavioural therapy principles to support parents manage their child's JIA. An economic evaluation was performed alongside the trial involving 220 parents. The primary outcome was the self-report Pediatric Inventory for Parents measure of illness-related parenting stress, with two dimensions: difficulty and frequency. These measures along with costs were assessed post intervention at 4 and 12 months. Costs were calculated for healthcare usage using a UK NHS economic perspective. Data was collected and analysed on the impact of caring costs on families. Uncertainty around cost-effectiveness was explored using bootstrapping and cost-effectiveness acceptability curves.Results The intervention arm showed improved average Pediatric Inventory for Parents scores for the dimensions of frequency and difficulty, of 1.5 and 3.6 respectively at 4 months and 0.35 and 0.39 at 12 months, representing improved PIP scores for the intervention arm. At both 4 and 12 month follow-up, the average total cost per case was higher in the control group when compared with the intervention arm with mean differences of 360 pound (95% CI 29.6 pound to 691) pound at 4 months and 203 pound (95% CI 16 pound to 390) pound at 12 months. The probability of the intervention being cost-effective ranged between 49% and 54%.Conclusion The WebParC intervention led to reductions in primary and secondary healthcare resource use and costs at 4 and 12 months. The intervention demonstrated particular savings for rheumatology services at both follow-ups. Future economies of scale could be realised by health providers with increased opportunities for cost-effectiveness over time.Trial registration ISRCTN, ISRCTN13159730.

ObjectivesSubjective reports of cognitive impairment following chemotherapy are frequent in cancer patients. Objective cognitive impairment has been observed in cancer patients regardless of treatment regimen suggesting the relationship between cognitive impairment and chemotherapy is not clear cut. Little research has explored the effects of chemotherapy on cognition following surgery in colorectal cancer (CRC). The present study explored the effects of chemotherapy on cognitive performance in a sample of CRC patients. Methods136 participants were recruited into a prospective cohort study: 78 CRC patients undergoing surgery and adjuvant chemotherapy, 58 CRC patients undergoing surgery only. A battery of neuropsychological tests was administered to participants 4 weeks post-surgery (T1), 12 weeks after first chemotherapy (T2) and 3 months after last chemotherapy (T3) or equivalent time-points. ResultsUsing the criterion of scoring at least two standard-deviations below the group norm on at least one neuropsychological test, 45%-55% of all CRC patients showed cognitive deficits 10 months after surgery (T3) and 14% on at least 3 tests. However, cognition did not significantly differ between patients who had chemotherapy and those who did not. A time by group interaction effect was found on the composite cognition score using multi-level modelling suggesting a greater improvement in cognition in the surgery only group over time (p < 0.05). ConclusionsCRC patients display cognitive impairment 10 months after surgery. Chemotherapy did not worsen cognitive impairment but did appear to slow cognitive recovery relative to those undergoing surgery only. The findings demonstrate a clear need for supportive cognitive interventions for all CRC patients following treatment.

Cognitive impairment is common in patients with end-stage renal disease (ESRD) and is associated with compromised quality of life and functional capacity, as well as worse clinical outcomes. Most previous research and reviews in this area were focused on objective cognitive impairment, whereas patients' subjective cognitive complaints (SCCs) have been less well-understood. This systematic review aimed to provide a broad overview of what is known about SCCs in adult ESRD patients. Electronic databases were searched from inception to January 2022, which identified 221 relevant studies. SCCs appear to be highly prevalent in dialysis patients and less so in those who received kidney transplantation. A random-effects meta-analysis also shows that haemodialysis patients reported significantly more SCCs than peritoneal dialysis patients (standardised mean difference -0.20, 95% confidence interval -0.38 to -0.03). Synthesis of longitudinal studies suggests that SCCs remain stable on maintenance dialysis treatment but may reduce upon receipt of kidney transplant. Furthermore, SCCs in ESRD patients have been consistently associated with hospitalisation, depression, anxiety, fatigue, and poorer quality of life. There is limited data supporting a strong relation between objective and subjective cognition but preliminary evidence suggests that this association may be domain-specific. Methodological limitations and future research directions are discussed.

OBJECTIVES Cognitive impairment is common in haemodialysis patients and is associated with increased hospitalization and mortality. However, subjective cognitive complaints (SCCs), the self-experienced difficulties in everyday cognitive activities, remain poorly understood. This study examined the prevalence and course of SCCs in haemodialysis patients and its longitudinal associations with sociodemographic, clinical and patient-reported variables. DESIGN Observational prospective study with baseline and 12-month follow-up assessment. METHODS Based on a validated cut-off point on the Kidney Disease Quality of Life Cognitive Function subscale, haemodialysis patients (N = 159; 40.3% female, mean age 53.62) were classified into cognitive complaint trajectories: (1) resilient (60.4%; no/low SCCs throughout); (2) persistent (8.8%; stable high SCCs); (3) deterioration (17.6%; from no/low to high SCCs); and (4) recovery (13.2%; from high to no/low SCCs). Sociodemographic/clinical characteristics, self-efficacy, self-management skills, adherence, mood and biochemical assays were measured at both assessments and compared among trajectories using mixed ANOVAs. RESULTS Interaction effects indicated significant improvements in the recovery group in clinical outcomes (i.e., decreased phosphorus and calcium-phosphorus product), self-efficacy and mood over time. Group effects indicated significantly poorer self-efficacy, self-management skills and adherence in the persistent group than other trajectories across both assessments. None of the sociodemographic/clinical characteristics was associated with SCC trajectories. CONCLUSIONS The extent of SCCs vary over time across haemodialysis patients. Routine screening of SCCs in dialysis settings may help identifying patients at risk of poor self-management and worse prognosis. Strategies that compensate for cognitive lapses may mitigate the perceived cognitive burden of this population.

Many studies encounter clustering due to multicenter enrollment and nonmortality outcomes, such as quality of life, that are truncated due to death-that is, missing not at random and nonignorable. Traditional missing-data methods and target causal estimands are suboptimal for statistical inference in the presence of these combined issues, which are especially common in multicenter studies and cluster-randomized trials (CRTs) carried out among the elderly or seriously ill. Using principal stratification, we developed a Bayesian estimator that jointly identifies the always-survivor principal stratum in a clustered/hierarchical data setting and estimates the average treatment effect among them (i.e., the survivor average causal effect (SACE)). In simulations, we observed low bias and good coverage with our method. In a motivating CRT, the SACE and the estimate from complete-case analysis differed in magnitude, but both were small, and neither was incompatible with a null effect. However, the SACE estimate has a clear causal interpretation. The option to assess the rigorously defined SACE estimand in studies with informative truncation and clustering can provide additional insight into an important subset of study participants. Based on the simulation study and CRT reanalysis, we provide practical recommendations for using the SACE in CRTs and software code to support future research.

Introduction:Most patients with Adrenal insufficiency (AI) require lifelong glucocorticoid replacement. They need to increase glucocorticoids during physical illness or major stressful situations and require parenteral hydrocortisone in the event of an adrenal crisis. Patients with AI have impaired quality of life and high mortality; approximately 1 in 6-12 patients are hospitalised at least once/year from a potentially preventable adrenal crisis. Adoption of self-management behaviours are crucial; these include adherence to medication, following "sick day rules" and associated behaviours that aid prevention and treatment of adrenal crisis such as symptom monitoring, having extra tablets, carrying a medical-alert ID and injection kit, and self-injecting when necessary. Current patient education is ineffective at supporting self-management behaviour change or reducing adrenal crisis-related hospitalisations. This research study aims to gain an in-depth understanding of the barriers and enablers to self-management for patients with AI and to develop an evidence-based digital self-management behaviour change intervention.Methods:The study is conducted in accordance with the MRC Framework for developing complex interventions. Underpinned by the Behaviour Change Wheel (BCW), the Theoretical Domains Framework (TDF), and the Person-Based Approach, this research will be conducted in two phases: Phase 1 will involve a sequential qualitative/quantitative mixed-methods study involving focus group interviews followed by a cross-sectional survey with patients with AI recruited from patient advocacy groups and endocrine clinics in the UK. Phase 2 will develop the Support AI, a website-based digital behaviour change intervention (DBCI) informed by Phase 1 findings to support self-management for patients with AI. The most appropriate behaviour change techniques (BCTs) will be selected utilising a nominal group technique with an Expert Panel of 10-15 key stakeholders. The design of the Support AI website will be guided by the Person-Based Approach using an Agile iterative "think-aloud" technique with 12-15 participants over 3 usability testing iterations.Conclusion:A theory- and evidence-based digital behaviour change intervention will be developed which will be tested in a feasibility randomised trial following completion of this study. The projected benefit includes cost-effective health care service (reduced hospitalisations and demand for specialist services) and improved health outcomes and quality of life for patients with AI.

INTRODUCTION:Caregivers who live with a person with dementia who receives care, compared with those who live elsewhere, are often considered to experience greater levels of psychological and affective burden. The evidence for this is, however, only limited to studies employing small sample sizes and that failed to examine caregivers' psychological wellbeing. We address these issues in a large cohort of dementia caregivers. METHODS:We conducted a cross-sectional study comparing caregivers living with a dementia care recipient (n = 240) to caregivers living elsewhere (n = 255) on caregivers' burden, anxiety, and depression. RESULTS:We found that caregivers living with the care recipient relative to those living elsewhere showed significantly greater burden and depression, but we found no group difference in anxiety. CONCLUSIONS:Our study adds to the evidence by showing that cohabiting with a care recipient with dementia is associated with greater burden and poorer psychological wellbeing. Strategies aiming to improve caregivers' burden and psychological wellbeing should take account of caregivers' living arrangements.

BACKGROUND:Juvenile idiopathic arthritis (JIA) is a group of autoinflammatory diseases that cause pain and disability if not controlled by treatment. Parenting a child with JIA is stressful for parents, who express concerns about their child's treatment and may experience anxiety and powerlessness concerning their child's illness. Parenting stress is greater in parents of children with chronic illness than in those with healthy children and is related to poorer psychological adjustment in both parents and children. It is therefore important to develop interventions to support parents. This paper reports the evaluation of a web-based tool that provides information and practical skills to help increase parents' confidence in managing their child's illness and reduce parenting stress. OBJECTIVE:The aim of this study is to evaluate the benefits of a web-based tool (WebParC) for parents of children with recently diagnosed JIA. METHODS:A multicentered randomized controlled trial was conducted at pediatric rheumatology centers in England. We recruited parents of children aged ≤12 years who had been diagnosed with JIA within the previous 6 months. They were randomized to the intervention (WebParC access plus standard care) or the control (standard care alone) and followed up 4 months and 12 months after randomization. Where both parents participated, they were randomized by household to the same trial arm. The WebParC intervention consists of information about JIA and its treatment plus a toolkit, based on cognitive behavioral therapy, to help parents develop skills to manage JIA-related issues. The primary outcome was the self-report Pediatric Inventory for Parents measure of illness-related parenting stress. The secondary outcomes were parental mood, self-efficacy, coping, effectiveness of participation in their child's health care, satisfaction with health care, and child's health-related quality of life. RESULTS:A total of 203 households comprising 220 parents were randomized to the intervention (100/203, 49.3%) or control (103/203, 50.7%) arm. Follow-up assessments were completed by 65.5% (133/203) of the households at 4 months (intervention 60/100, 60%, and control 73/103, 70.9%) and 61.1% (124/203) of the households at 12 months (intervention 58/100, 58%, and control 66/103, 64.1%). A main effect of the trial arm was found on the Pediatric Inventory for Parents: the intervention participants reported less frequency (subscales communication F1,120627=5.37; P=.02, and role function F1,27203=5.40; P=.02) and difficulty (subscales communication F1,2237=7.43; P=.006, medical care F1,2907=4.04; P=.04, and role function F1,821=4.37, P=.04) regarding illness-related stressful events than the control participants. CONCLUSIONS:The WebParC website for parents of children with JIA reduced illness-related parenting stress. This web-based intervention offers a feasible preventive approach for parents of children with JIA and potentially could be adapted and evaluated for parents of children with other chronic illnesses. TRIAL REGISTRATION:International Standard Randomized Controlled Trial Number (ISRCTN) 13159730; http://www.isrctn.com/ISRCTN13159730.

Background Subjective cognitive complaints refer to self-experienced difficulties with everyday cognitive tasks. Although there has been a fair amount of research on cognitive impairments and cognitive complaints in end-stage renal disease, the practical implications of these complaints remain unclear. The current study aims to examine the associations of cognitive complaints with sociodemographic and clinical variables, mood, as well as key patient-reported outcomes, i.e., self-efficacy, self-management skills, and treatment adherence. Methods A total of 305 haemodialysis patients (mean age = 53.97 years, 42.6% female) completed the Kidney Disease Quality of Life Cognitive Function subscale, a brief measure of cognitive complaints. The recommended cut-off point of 60 was used to identify probable cognitive impairment. Measures of self-efficacy, self-management skills (i.e., symptom coping, health monitoring, health service navigation), treatment adherence, and mood symptoms were also administered. Between-group comparisons and correlational analyses were performed to examine associations of cognitive complaints with sociodemographic, clinical, and health behaviour variables. Mediation analyses were also conducted to investigate the mediating role of self-efficacy on the relationship between cognitive complaints and treatment adherence. Results Nearly a quarter (23.0%) of haemodialysis patients reported cognitive complaints indicative of clinical impairments. Risk of probable impairments was higher for patients with hypertension, diabetes, those diagnosed with end-stage renal disease at an older age, and those with shorter time on dialysis. Subjective cognitive complaints (both rates of probable impairments as per cut-off and continuous scores) were significantly associated with lower disease and treatment self-efficacy, poorer self-management skills, lower treatment adherence, as well as higher symptoms of distress. Mediation analysis indicated that treatment self-efficacy mediated the relationship between cognitive complaints and treatment adherence. Conclusions The current study demonstrated the clinical characteristics of haemodialysis patients who report cognitive complaints indicative of probable cognitive impairments and showed the associations of these complaints with self-management outcomes. Future studies should adopt more comprehensive measures of cognitive complaints and longitudinal designs to confirm the current findings.

RATIONALE & OBJECTIVE:Suboptimal dialysis preparation of patients with chronic kidney disease (CKD) is common, but little is known about its relationship to psychosocial factors. This study aimed to assess patients' attitudes about access creation and to identify factors associated with patients' intentions regarding dialysis access creation and outcomes.STUDY DESIGN:Prospective cohort study.SETTING & PARTICIPANTS:190 patients with stage 4/5 CKD not receiving dialysis treated at 2 hospitals in Singapore and 128 of their family members.PREDICTORS:Self-reported measures of illness perception, health-related quality of life, and attitudes toward access creation. Sociodemographic and clinical measures were also obtained.OUTCOME:Intention to create an arteriovenous fistula (AVF; ie, proceed with access vs wait and see) and time to creation of a functional AVF.ANALYTICAL APPROACH:Exploratory factor analysis (EFA) was undertaken to construct internally consistent subscales for a newly developed questionnaire about attitudes toward access creation. Logistic regression and cause-specific hazards models were conducted to identify psychosocial factors associated with patients' access creation intentions and access outcomes, respectively.RESULTS:EFA (explained 50.1% variance) revealed 4 domains: access and dialysis concerns, need for dialysis, worry about cost, and value of access. A high risk of intention to delay access creation (51.1%) was found among patients despite early referral and education. Multivariable analysis (R2=0.45) showed that the intention to proceed with access creation was associated with greater perceived value from access (odds ratio, 2.61; 95% CI, 1.46-4.65; P<0.001).LIMITATIONS:Limited generalization, as only those already receiving nephrology care were studied.CONCLUSIONS:Approximately half of the patients studied planned to delay access creation. The questionnaire developed to evaluate attitudes about access creation may help identify individuals for whom decision-support programs would be useful. These findings highlight the need to understand and address patients' concerns about access creation.

Objective To gain a better understanding of uncertainty regarding the illness experienced by parents of children with juvenile idiopathic arthritis (JIA). Methods Parents/guardians of a child or young person (aged less than 18 years) diagnosed JIA were recruited in the United Kingdom via the National Rheumatoid Arthritis Society JIA group. Semistructured telephone interviews were conducted with the parents. Results Twenty parents took part, including 19 mothers and one father. Their children with JIA were mostly female (n = 15; 75%) with polyarticular arthritis (n = 12; 60%), averaged 8 years of age, and had been diagnosed for a mean of 3.7 (SD 2.3) years. Parents expressed uncertainty in the following five key domains: diagnosis, cause, symptoms, and prognosis; medical management; impact; parenting uncertainty; and awareness of JIA. All participants expressed uncertainty in at least four of the five domains. Although parents’ uncertainty in the early stages of the disease related to lack of information and understanding of JIA, much uncertainty could not be resolved by receipt of information. These included concerns about their child’s future and a lack of support with managing the emotional aspects of living with JIA. Conclusion We found that parents’ experiences of uncertainty went beyond dealing with the purely medical aspects of JIA. Provision of information about JIA, although essential, is not sufficient to help parents manage the considerable uncertainty they experience about many aspects of their child’s JIA. Identifying ways to incorporate support for coping with uncertainty into routine care will be an important way of supporting parents to care for their child with JIA.

Background Policy makers and care providers see assistive technology and telecare as potential products to support people with dementia to live independently in their homes and communities. Previous research rarely examined how people with dementia and their caregivers actually use such technology. The study examined how and why people living with dementia and their caregivers used assistive technology and telecare in their own homes. Methods This study used an ethnographic design embedded within the NIHR-funded Assistive Technology and Telecare to maintain Independent Living At home for people with dementia (ATTILA) randomised controlled trial. We collected 208 h of observational data on situated practices of ten people with dementia and their ten caregivers. We used this data to construct extended cases to explain how technologies supported people with dementia in home and community settings. Results We identified three themes: placing technology in care, which illustrates how people with dementia and caregivers 'fit' technology into their homes and routines; replacing care with technology, which shows how caregivers replaced normal care practices with ones mediated through technologies; and technology displacing care and everyday life, which highlights how technologies disrupted the everyday lives of people with dementia. Discussion This study exemplifies unintended and unanticipated consequences for assistive technology and telecare uptake in 'real world' community-based dementia care. It underlines the need to identify and map the context of technological provision over time within the changing lives of people with dementia and their caregivers.