Background: Improving quality of care for people with dementia is a high priority. Considerable resources have been invested in financial incentives, guideline development, public awareness and educational programmes to promote earlier diagnosis and better management.Objectives: Evaluating family physicians’ concordance with guidelines on diagnosis and management of people with dementia, from first documentation of symptoms to formal diagnosis.Method: Analysis of medical records of 136 people with dementia recruited by 19 family practices in NW London and surrounding counties.Results: Practices invited 763 people with dementia to participate, 167 (22%) agreed. Complete records were available for 136 (18%). The majority of records included reference to recommended blood tests, informant history and caregiver concerns. Presence or absence of symptoms of depression, psychosis, other behavioural and psychological symptoms of dementia, and cognitive function tests were documented in 30%–40% of records. Documentation of discussions about signs and symptoms of dementia, treatment options, care, support, financial, legal and advocacy advice were uncommon. Comparison of these findings from a similar study in 2000–2002 suggests improvements in concordance with blood tests, recording informant history, presence or absence of depression or psychosis symptoms. There was no difference in documenting cognitive function tests. Immediate referral to specialists was more common in the recent study.Conclusion: Five years after UK dementia guidelines and immediately after the launch of the dementia strategy, family physicians appeared concordant with clinical guidelines for dementia diagnosis (other than cognitive function tests), and referred most patients immediately. However, records did not suggest systematic dementia management.
BackgroundManagement of long-term depression is a significant problem in primary care populations with considerable on-going morbidity, but few studies have focused on this group.AimsTo evaluate whether structured, nurse-led proactive care of patients with chronic depression in primary care improves outcomes.MethodParticipants with chronic/recurrent major depression or dysthymia were recruited from 42 UK general practices and randomised to general practitioner (GP) treatment as usual or nurse intervention over 2 years (the ProCEED trial, trial registration: ISRCTN36610074).ResultsIn total 282 people received the intervention and there were 276 controls. At 24 months there was no significant improvement in Beck Depression Inventory (BDI-II) score or quality of life (Euroquol-EQ-VAS), but a significant improvement in functional impairment (Work and Social Activity Schedule, WSAS) of 2.5 (95% CI 0.6-4.3, P = 0.010) in the intervention group. The impact per practice-nurse intervention session was -0.37 (95% CI -0.68 to -0.07, P = 0.017) on the BDI-II score and -0.33 (95% CI -0.55 to -0.10, P = 0.004) on the WSAS score, indicating that attending all 10 intervention sessions could lead to a BDI-II score reduction of 3.7 points compared with controls.ConclusionsThe intervention improved functioning in these patients, the majority of whom had complex long-term difficulties, but only had a significant impact on depressive symptoms in those engaging with the full intervention.Declaration of interestNone.Copyright and usage(C) The Royal College of Psychiatrists 2016.
Background: Family carers of people with dementia frequently report acting abusively toward them and carer psychological morbidity predicts this. We investigated whether START (STrAtegies for RelaTives), a psychological intervention which reduces depression and anxiety in family carers also reduces abusive behavior in carers of people living in their own homes. We also explored the longitudinal course of carer abusive behavior over two year.Methods: We included self-identified family carers who gave support at least weekly to people with dementia referred in the previous year to three UK mental health services and a neurological dementia service. We randomly assigned these carers to START, an eight-session, manual-based coping intervention, or treatment as usual (TAU). Carer abusive behavior (Modified Conflict Tactic Scale (MCTS) score >= 2 representing significant abuse) was assessed at baseline, 4, 8, 12, and 24 months.Results: We recruited 260 carers, 173 to START and 87 to TAU. There was no evidence that abusive behavior levels differed between randomization groups or changed over time. A quarter of carers still reported significant abuse after two years, but those not acting abusively at baseline did not become abusive.Conclusion: There was no evidence that START, which reduced carer anxiety and depression, reduced carer abusive behavior. For ethical reasons, we frequently intervened to manage concerning abuse reported in both groups, which may have disguised an intervention effect. Future dementia research should include elder abuse as an outcome, and consider carefully how to manage detected abuse.
AimsThe main aim of this qualitative evaluation was to provide patient and clinic staff perspectives on online trial procedures, to inform the optimum design of a future full-scale RCT.Methods
AimsTo establish the feasibility and optimal design of a full-scale RCT to test the effect of the Men’s Safer Sex intervention website on condom use and STI acquisition in men attending sexual health clinics.MethodsDesignThis study is a feasibility RCT with random allocation to the Men’s Safer Sex website plus usual sexual health clinical care compared with usual sexual health clinical care only.
BACKGROUND:This report details the development of the Men's Safer Sex website and the results of a feasibility randomised controlled trial (RCT), health economic assessment and qualitative evaluation. OBJECTIVES:(1) Develop the Men's Safer Sex website to address barriers to condom use; (2) determine the best design for an online RCT; (3) inform the methods for collecting and analysing health economic data; (4) assess the Sexual Quality of Life (SQoL) questionnaire and European Quality of Life-5 Dimensions, three-level version (EQ-5D-3L) to calculate quality-adjusted life-years (QALYs); and (5) explore clinic staff and men's views of online research methodology. METHODS:(1) Website development: we combined evidence from research literature and the views of experts (n = 18) and male clinic users (n = 43); (2) feasibility RCT: 159 heterosexually active men were recruited from three sexual health clinics and were randomised by computer to the Men's Safer Sex website plus usual care (n = 84) or usual clinic care only (n = 75). Men were invited to complete online questionnaires at 3, 6, 9 and 12 months, and sexually transmitted infection (STI) diagnoses were recorded from clinic notes at 12 months; (3) health economic evaluation: we investigated the impact of using different questionnaires to calculate utilities and QALYs (the EQ-5D-3L and SQoL questionnaire), and compared different methods to collect resource use; and (4) qualitative evaluation: thematic analysis of interviews with 11 male trial participants and nine clinic staff, as well as free-text comments from online outcome questionnaires. RESULTS:(1) Software errors and clinic Wi-Fi access presented significant challenges. Response rates for online questionnaires were poor but improved with larger vouchers (from 36% with £10 to 50% with £30). Clinical records were located for 94% of participants for STI diagnoses. There were no group differences in condomless sex with female partners [incidence rate ratio (IRR) 1.01, 95% confidence interval (CI) 0.52 to 1.96]. New STI diagnoses were recorded for 8.8% (7/80) of the intervention group and 13.0% (9/69) of the control group (IRR 0.75, 95% CI 0.29 to 1.89). (2) Health-care resource data were more complete using patient files than questionnaires. The probability that the intervention is cost-effective is sensitive to the source of data used and whether or not data on intended pregnancies are included. (3) The pilot RCT fitted well around clinical activities but 37% of the intervention group did not see the Men's Safer Sex website and technical problems were frustrating. Men's views of the Men's Safer Sex website and research procedures were largely positive. CONCLUSIONS:It would be feasible to conduct a large-scale RCT using clinic STI diagnoses as a primary outcome; however, technical errors and a poor response rate limited the collection of online self-reported outcomes. The next steps are (1) to optimise software for online trials, (2) to find the best ways to integrate digital health promotion with clinical services, (3) to develop more precise methods for collecting resource use data and (4) to work out how to overcome barriers to digital intervention testing and implementation in the NHS. TRIAL REGISTRATION:Current Controlled Trials ISRCTN18649610. FUNDING:This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 91. See the NIHR Journals Library website for further project information.
OBJECTIVES:We aimed to determine the feasibility of an online randomised controlled trial (RCT) of the Men's Safer Sex website, measuring condom use and sexually transmitted infection (STI). METHODS:For this study 159 men aged ≥16 with female sexual partners and recent condomless sex or suspected STI were recruited from three UK sexual health clinics. Participants were randomised to the intervention website plus usual clinic care (n = 84), or usual clinic care only (n = 75). Online outcome data were solicited at 3, 6, and 12 months. RESULTS:Men were enrolled via tablet computers in clinic waiting rooms. Software errors and clinic Wi-Fi access presented significant challenges, and online questionnaire response rates were poor (36% at 3 months with a £10 voucher; 50% at 12 months with £30). Clinical records (for STI diagnoses) were located for 94% of participants. Some 37% of the intervention group did not see the intervention website (n = 31/84), and (as expected) there was no detectable difference in condomless sex with female partners (IRR = 1.01, 95% CI 0.52 to 1.96). New acute STI diagnoses were recorded for 8.8% (7/80) of the intervention group, and 13.0% (9/69) of the control group over 12 months (IRR = 0.75, 95% CI 0.29 to 1.90). CONCLUSION:It is likely to be feasible to conduct a future large-scale RCT to assess the impact of an online intervention using clinic STI diagnoses as a primary outcome. However, practical and technical challenges need to be addressed before the potential of digital media interventions can be realised in sexual health settings.Trial registration number: ISRCTN18649610.
BACKGROUNDRegular physical activity reduces falls, hip fractures, and all-cause mortality, but physical activity levels are low in older age groups.AIMTo evaluate two exercise programmes promoting physical activity among older people.DESIGN AND SETTINGPragmatic three-arm, parallel-design cluster randomised controlled trial involving 1256 people aged ≥65 years (of 20 507 invited) recruited from 43 general practices in London, Nottingham, and Derby.METHODPractices were randomised to the class-based Falls Management Exercise programme (FaME), the home-based Otago Exercise Program (OEP), or usual care. The primary outcome was the proportion reaching the recommended physical activity target 12 months post-intervention. Secondary outcomes included falls, quality of life, balance confidence, and costs.RESULTSIn total, 49% of FaME participants reached the physical activity target compared with 38% for usual care (adjusted odds ratio 1.78, 95% confidence interval [CI] =1.11 to 2.87, P = 0.02). Differences between FaME and usual care persisted 24 months after intervention. There was no significant difference comparing those in the OEP (43% reaching target at 12 months) and usual-care arms. Participants in the FaME arm added around 15 minutes of moderate-to-vigorous physical activity per day to their baseline level; this group also had a significantly lower rate of falls (incident rate ratio 0.74, 95% CI = 0.55 to 0.99, P = 0.042). Balance confidence was significantly improved in both intervention arms. The mean cost per extra person achieving the physical activity target was £1740. Attrition and rates of adverse reactions were similar.CONCLUSIONThe FaME programme increases self-reported physical activity for at least 12 months post-intervention and reduces falls in people aged ≥65 years, but uptake is low. There was no statistically significant difference in reaching the target, or in falls, between the OEP and usual-care arms.
Elder abuse may be defined as violating a vulnerable older person's rights and includes behavior, such as shouting, which people may not realise is abusive. People with dementia are particularly at risk. Family caregivers are more likely to act harmfully if depressed or anxious. There are no evidence-based effective interventions. We hypothesized, that START (STrAtegies for RelaTives, a randomized controlled trial (RCT) of coping strategies for family caregivers of people with dementia, which reduced short and longer term affective symptoms (8 and 24 months), would also reduce harmful behavior towards care recipients who lived at home compared to treatment as usual (TAU). We interviewed caregivers at baseline, 4, 8, 12 and 24 months. Our outcome was the Modified Conflict Tactic Scale (MCTS) which has ten potentially harmful behaviors (scored as harmful behavior [≥2 on any item] or as a continuous scale) ranging from shouting, to threatening, to slapping. We used random effects models allowing for therapist clustering and repeated measures which adjusted for baseline MCTS, burden and neuropsychiatric symptoms; centre, patient age and sex, to consider differences in potentially abusive behavior between randomized groups. We randomized 173 caregivers to START and 87 to TAU. 38 (43.7%) from TAU and 82 (47.7%) START group scored ≥2 on MCTS at randomisation. There was no significant difference in the proportion with MCTS score ≥2 between randomization groups over two years (OR 0.65 (95% Confidence Interval 0.31,1.36) p=0.253). Short-term (4 and 8 months) those receiving the intervention reported less abuse (OR 0.47 (0.16,1.36), p=0.16) but not-significantly so. Our sensitivity analysis using repeated measures in those who were followed up at both 4 and 8 months showed those in the intervention group had lower scores (F= 5.723, p=.018). This is the first RCT with abusive behaviour in dementia as an outcome. Although in our main analysis there was no significant decrease in abusive behaviour, in our sensitivity analysis there was in those who remained in the study over 8months. The study was not powered on this outcome but these preliminary results suggest further development is warranted.
ObjectiveAlthough available evidence is modest, exercise could be beneficial in reducing behavioural and psychological symptoms of dementia. We aim to evaluate the cost‐effectiveness of a dyadic exercise regimen for individuals with dementia and their main carer as therapy for behavioural and psychological symptoms of dementia.MethodsCost‐effectiveness analysis within a two‐arm, pragmatic, randomised, controlled, single‐blind, parallel‐group trial of a dyadic exercise regimen (individually tailored, for 20–30 min at least five times per week). The study randomised 131 community‐dwelling individuals with dementia and clinically significant behavioural and psychological symptoms with a carer willing and able to participate in the exercise regimen; 52 dyads provided sufficient cost data for analyses.ResultsMean intervention cost was £284 per dyad. For the subsample of 52 dyads, the intervention group had significantly higher mean cost from a societal perspective (mean difference £2728.60, p = 0.05), but costs were not significantly different from a health and social care perspective. The exercise intervention was more cost‐effective than treatment as usual from both societal and health and social care perspectives for the measure of behavioural and psychological symptoms (Neuropsychiatric Inventory). It does not appear cost‐effective in terms of cost per quality‐adjusted life year gain.ConclusionsThe exercise intervention has the potential to be seen as cost‐effective when considering behavioural and psychological symptoms but did not appear cost‐effective when considering quality‐adjusted life year gains. Copyright © 2011 John Wiley & Sons, Ltd.
Sedentary behaviour is detrimental to health, even in those who achieve recommended levels of physical activity. Efforts to increase physical activity in older people so that they reach beneficial levels have been disappointing. Reducing sedentary behaviour may improve health and be less demanding of older people, but it is not clear how to achieve this. We explored the characteristics of sedentary older people enrolled into an exercise promotion trial to gain insights about those who were sedentary but wanted to increase activity.
Background: The needs of people with dementia and their carers are inadequately addressed at all key points in the illness trajectory, from diagnosis through to end-of-life care. The EVIDEM (Evidence-based Interventions in Dementia) research and development programme (2007–12) was designed to help change this situation within real-life settings. Objectives: The EVIDEM projects were (1) evaluation of an educational package designed to enhance general practitioners’ (GPs’) diagnostic and management skills; (2) evaluation of exercise as therapy for behavioural and psychological symptoms of dementia (BPSD); (3) development of a toolkit for managing incontinence in people with dementia living at home; (4) development of a toolkit for palliative care for people with dementia; and (5) development of practice guidance on the use of the Mental Capacity Act (MCA) 2005. Design: Mixed quantitative and qualitative methods from case studies to large database analyses, including longitudinal surveys, randomised controlled trials and research register development, with patient and public involvement built into all projects. Setting: General practices, community services, third-sector organisations and care homes in the area of the North Thames Dementia and Neurodegenerative Diseases Research Network local research network. Participants: People with dementia, their family and professional carers, GPs and community mental health team members, staff in local authority social services and third-sector bodies, and care home staff. Main outcome measures: Dementia management reviews and case identification in general practice; changes in behavioural and psychological symptoms measured with the Neuropsychiatric Inventory (NPI); extent and impact of incontinence in community-dwelling people with dementia; mapping of pathways to death of people with dementia in care homes, and testing of a model of collaborative working between primary care and care homes; and understandings of the MCA 2005 among practitioners working with people with dementia. Results: An educational intervention in general practice did not alter management or case identification. Exercise as a therapy for BPSD did not reduce NPI scores significantly, but had a significant positive effect on carer burden. Incontinence is twice as common in community-dwelling people with dementia than their peers, and is a hidden taboo within a stigma. Distinct trajectories of dying were identified (anticipated, unexpected and uncertain), and collaboration between NHS primary care and care homes was improved, with cost savings. The MCA 2005 legislation provided a useful working framework for practitioners working with people with dementia. Conclusions: A tailored educational intervention for general practice does not change practice, even when incentives, policy pressure and consumer demand create a favourable environment for change; exercise has potential as a therapy for BPSD and deserves further investigation; incontinence is a common but unrecognised problem for people with dementia in the community; changes in relationships between care homes and general practice can be achieved, with benefits for people with dementia at the end of life and for the UK NHS; application of the MCA 2005 will continue to improve but educational reinforcements will help this. Increased research capacity in dementia in the community was achieved. This study suggests that further work is required to enhance clinical practice around dementia in general practice; investigate the apparent beneficial effect of physical activity on BPSD and carer well-being; develop case-finding methods for incontinence in people with dementia; optimise working relationships between NHS staff and care homes; and reinforce practitioner understanding of the MCA 2005. Trial registration: EVIDEM: ED-NCT00866099; EVIDEM: E-ISRCTN01423159. Funding: This project was funded by the Programme Grants for Applied Research programme of the National Institute for Health Research.