The Stroke Prevention Programme: a programme of research to inform optimal stroke prevention in primary care

BackgroundThe management of cardiovascular (CV) risk factors in community populations is suboptimal. The aim of this programme was to explore the role of three approaches [use of a ‘polypill’; self-management of hypertension; and more intensive targets for blood pressure (BP) lowering after stroke] to improve prevention of CV disease (CVD) in the community.Research questions(1) Is it more cost-effective to titrate treatments to target levels of cholesterol and BP or to use fixed doses of statins and BP-lowering agents (polypill strategy)? (2) Will telemonitoring and self-management improve BP control in people on treatment for hypertension or with a history of stroke/transient ischaemic attack (TIA) in primary care and are they cost-effective? (3) In people with a history of stroke/TIA, can intensive BP-lowering targets be achieved in a primary care setting and what impact will this have on health outcomes and cost-effectiveness?DesignMixed methods, comprising three randomised controlled trials (RCTs); five cost-effectiveness analyses; qualitative studies; analysis of electronic general practice data; a screening study; a systematic review; and a questionnaire study.SettingUK general practices, predominantly from the West Midlands and the east of England.ParticipantsAdults registered with participating general practices. Inclusion criteria varied from study to study.InterventionsA polypill – a fixed-dose combination pill containing three antihypertensive medicines and simvastatin – compared with current practice and with optimal implementation of national guidelines; self-monitoring of BP with self-titration of medication, compared with usual care; and an intensive target for systolic BP of < 130 mmHg or a 10 mmHg reduction if baseline BP is < 140 mmHg, compared with a target of < 140 mmHg.ResultsFor patients known to be at high risk of CVD, treatment as per guidelines was the most cost-effective strategy. For people with unknown CV risk aged ≥ 50 years, offering a polypill is cost-effective [incremental cost-effectiveness ratio (ICER) of £8115 per quality-adjusted life-year (QALY)] compared with a strategy of screening and treating according to national guidelines. Both results were sensitive to the cost of the polypill. Self-management in people with uncontrolled hypertension led to a 5.4 mmHg [95% confidence interval (CI) 2.4 to 8.5 mmHg] reduction in systolic BP at 1 year, compared with usual care. It was cost-effective for men (ICER of £1624 per QALY) and women (ICER of £4923 per QALY). In people with stroke and other high-risk groups, self-management led to a 9.2 mmHg (95% CI 5.7 to 12.7 mmHg) reduction in systolic BP at 1 year compared with usual care and dominated (lower cost and better outcome) usual care. Aiming for the more intensive BP target after stroke led to a 2.9 mmHg (95% CI 0.2 to 5.7 mmHg) greater reduction in BP and dominated the 140 mmHg target.ConclusionsPotential for a polypill needs to be further explored in RCTs. Self-management should be offered to people with poorly controlled BP. Management of BP in the post-stroke population should focus on achieving a < 140 mmHg target.Trial registrationCurrent Controlled Trials ISRCTN17585681, ISRCTN87171227 and ISRCTN29062286.FundingThe National Institute for Health Research (NIHR) Programme Grants for Applied Research programme. Additional funding was provided by the NIHR National School for Primary Care Research, the NIHR Career Development Fellowship and the Department of Health Policy Research Programme.

Download Full-text

Cost-effectiveness of cognitive–behavioural therapy as an adjunct to pharmacotherapy for treatment-resistant depression in primary care: economic evaluation of the CoBalT Trial

The British Journal of Psychiatry ◽

10.1192/bjp.bp.112.125286 ◽

2014 ◽

Vol 204 (1) ◽

pp. 69-76 ◽

Cited By ~ 14

Author(s):

Sandra Hollinghurst ◽

Fran E. Carroll ◽

Anna Abel ◽

John Campbell ◽

Anne Garland ◽

...

Keyword(s):

Primary Care ◽

Cost Effectiveness ◽

Usual Care ◽

Social Care ◽

Cost Effective ◽

Behavioural Therapy ◽

Treatment Resistant ◽

Cognitive Behavioural ◽

Health And Social Care ◽

Resistant Depression

BackgroundDepression is expensive to treat, but providing ineffective treatment is more expensive. Such is the case for many patients who do not respond to antidepressant medication.AimsTo assess the cost-effectiveness of cognitive–behavioural therapy (CBT) plus usual care for primary care patients with treatment-resistant depression compared with usual care alone.MethodEconomic evaluation at 12 months alongside a randomised controlled trial. Cost-effectiveness assessed using a cost-consequences framework comparing cost to the health and social care provider, patients and society, with a range of outcomes. Cost-utility analysis comparing health and social care costs with quality-adjusted life-years (QALYs).ResultsThe mean cost of CBT per participant was £910. The difference in QALY gain between the groups was 0.057, equivalent to 21 days a year of good health. The incremental cost-effectiveness ratio was £14 911 (representing a 74% probability of the intervention being cost-effective at the National Institute of Health and Care Excellence threshold of £20 000 per QALY). Loss of earnings and productivity costs were substantial but there was no evidence of a difference between intervention and control groups.ConclusionsThe addition of CBT to usual care is cost-effective in patients who have not responded to antidepressants. Primary care physicians should therefore be encouraged to refer such individuals for CBT.

Download Full-text

Cost-effectiveness of telehealth for patients with depression: evidence from the Healthlines randomised controlled trial

BJPsych Open ◽

10.1192/bjpo.bp.116.002907 ◽

2016 ◽

Vol 2 (4) ◽

pp. 262-269 ◽

Cited By ~ 11

Author(s):

Padraig Dixon ◽

Sandra Hollinghurst ◽

Louisa Edwards ◽

Clare Thomas ◽

Alexis Foster ◽

...

Keyword(s):

Primary Care ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Usual Care ◽

Controlled Trial ◽

Cost Effective ◽

Monetary Benefit ◽

Randomised Controlled ◽

Net Monetary Benefit ◽

To Receive

BackgroundDepression is a prevalent long-term condition that is associated with substantial resource use. Telehealth may offer a cost-effective means of supporting the management of people with depression.AimsTo investigate the cost-effectiveness of a telehealth intervention (‘Healthlines’) for patients with depression.MethodA prospective patient-level economic evaluation conducted alongside a randomised controlled trial. Patients were recruited through primary care, and the intervention was delivered via a telehealth service. Participants with a confirmed diagnosis of depression and PHQ-9 score ≥10 were recruited from 43 English general practices. A series of up to 10 scripted, theory-led, telephone encounters with health information advisers supported participants to effect a behaviour change, use online resources, optimise medication and improve adherence. The intervention was delivered alongside usual care and was designed to support rather than duplicate primary care. Cost-effectiveness from a combined health and social care perspective was measured by net monetary benefit at the end of 12 months of follow-up, calculated from incremental cost and incremental quality-adjusted life years (QALYs). Cost–consequence analysis included cost of lost productivity, participant out-of-pocket expenditure and the clinical outcome.ResultsA total of 609 participants were randomised – 307 to receive the Healthlines intervention plus usual care and 302 to receive usual care alone. Forty-five per cent of participants had missing quality of life data, 41% had missing cost data and 51% of participants had missing data on either cost or utility, or both. Multiple imputation was used for the base-case analysis. The intervention was associated with incremental mean per-patient National Health Service/personal social services cost of £168 (95% CI £43 to £294) and an incremental QALY gain of 0.001 (95% CI −0.023 to 0.026). The incremental cost-effectiveness ratio was £132 630. Net monetary benefit at a cost-effectiveness threshold of £20 000 was –£143 (95% CI –£164 to –£122) and the probability of the intervention being cost-effective at this threshold value was 0.30. Productivity costs were higher in the intervention arm, but out-of-pocket expenses were lower.ConclusionsThe Healthlines service was acceptable to patients as a means of condition management, and response to treatment after 4 months was higher for participants randomised to the intervention. However, the positive average intervention effect size was modest, and incremental costs were high relative to a small incremental QALY gain at 12 months. The intervention is not likely to be cost-effective in its current form.

Download Full-text

Acupuncture for chronic pain and depression in primary care: a programme of research

Programme Grants for Applied Research ◽

10.3310/pgfar05030 ◽

2017 ◽

Vol 5 (3) ◽

pp. 1-316 ◽

Cited By ~ 16

Author(s):

Hugh MacPherson ◽

Andrew Vickers ◽

Martin Bland ◽

David Torgerson ◽

Mark Corbett ◽

...

Keyword(s):

Chronic Pain ◽

Cost Effectiveness ◽

Usual Care ◽

Research Programme ◽

Clinical Effectiveness ◽

Cost Effective ◽

Evidence Base ◽

Sham Acupuncture ◽

Osteoarthritis Of The Knee ◽

High Quality

BackgroundThere has been an increase in the utilisation of acupuncture in recent years, yet the evidence base is insufficiently well established to be certain about its clinical effectiveness and cost-effectiveness. Addressing the questions related to the evidence base will reduce uncertainty and help policy- and decision-makers with regard to whether or not wider access is appropriate and provides value for money.AimOur aim was to establish the most reliable evidence on the clinical effectiveness and cost-effectiveness of acupuncture for chronic pain by drawing on relevant evidence, including recent high-quality trials, and to develop fresh evidence on acupuncture for depression. To extend the evidence base we synthesised the results of published trials using robust systematic review methodology and conducted a randomised controlled trial (RCT) of acupuncture for depression.Methods and resultsWe synthesised the evidence from high-quality trials of acupuncture for chronic pain, consisting of musculoskeletal pain related to the neck and low back, osteoarthritis of the knee, and headache and migraine, involving nearly 18,000 patients. In an individual patient data (IPD) pairwise meta-analysis, acupuncture was significantly better than both sham acupuncture (p < 0.001) and usual care (p < 0.001) for all conditions. Using network meta-analyses, we compared acupuncture with other physical therapies for osteoarthritis of the knee. In both an analysis of all available evidence and an analysis of a subset of better-quality trials, using aggregate-level data, we found acupuncture to be one of the more effective therapies. We developed new Bayesian methods for analysing multiple individual patient-level data sets to evaluate heterogeneous continuous outcomes. An accompanying cost-effectiveness analysis found transcutaneous electrical nerve stimulation (TENS) to be cost-effective for osteoarthritis at a threshold of £20,000 per quality-adjusted life-year when all trials were synthesised. When the analysis was restricted to trials of higher quality with adequate allocation concealment, acupuncture was cost-effective. In a RCT of acupuncture or counselling compared with usual care for depression, in which half the patients were also experiencing comorbid pain, we found acupuncture and counselling to be clinically effective and acupuncture to be cost-effective. For patients in whom acupuncture is inappropriate or unavailable, counselling is cost-effective.ConclusionWe have provided the most robust evidence from high-quality trials on acupuncture for chronic pain. The synthesis of high-quality IPD found that acupuncture was more effective than both usual care and sham acupuncture. Acupuncture is one of the more clinically effective physical therapies for osteoarthritis and is also cost-effective if only high-quality trials are analysed. When all trials are analysed, TENS is cost-effective. Promising clinical and economic evidence on acupuncture for depression needs to be extended to other contexts and settings. For the conditions we have investigated, the drawing together of evidence on acupuncture from this programme of research has substantially reduced levels of uncertainty. We have identified directions for further research. Our research also provides a valuable basis for considering the potential role of acupuncture as a referral option in health care and enabling providers and policy-makers to make decisions based on robust sources of evidence.Trial registrationCurrent Controlled Trials ISRCTN63787732.FundingThe National Institute for Health Research Programme Grants for Applied Research programme.

Download Full-text

Model-based evaluation of the long-term cost-effectiveness of systematic case-finding for COPD in primary care

Thorax ◽

10.1136/thoraxjnl-2018-212148 ◽

2019 ◽

Vol 74 (8) ◽

pp. 730-739 ◽

Cited By ~ 7

Author(s):

Tosin Lambe ◽

Peymane Adab ◽

Rachel E Jordan ◽

Alice Sitch ◽

Alex Enocson ◽

...

Keyword(s):

Primary Care ◽

Cost Effectiveness ◽

Natural History ◽

Cost Effective ◽

Case Finding ◽

Base Case ◽

Decision Analytic Model ◽

Screening Questionnaire ◽

History Of

Introduction‘One-off’ systematic case-finding for COPD using a respiratory screening questionnaire is more effective and cost-effective than routine care at identifying new cases. However, it is not known whether early diagnosis and treatment is beneficial in the longer term. We estimated the long-term cost-effectiveness of a regular case-finding programme in primary care.MethodsA Markov decision analytic model was developed to compare the cost-effectiveness of a 3-yearly systematic case-finding programme targeted to ever smokers aged ≥50 years with the current routine diagnostic process in UK primary care. Patient-level data on case-finding pathways was obtained from a large randomised controlled trial. Information on the natural history of COPD and treatment effects was obtained from a linked COPD cohort, UK primary care database and published literature. The discounted lifetime cost per quality-adjusted life-year (QALY) gained was calculated from a health service perspective.ResultsThe incremental cost-effectiveness ratio of systematic case-finding versus current care was £16 596 per additional QALY gained, with a 78% probability of cost-effectiveness at a £20 000 per QALY willingness-to-pay threshold. The base case result was robust to multiple one-way sensitivity analyses. The main drivers were response rate to the initial screening questionnaire and attendance rate for the confirmatory spirometry test.DiscussionRegular systematic case-finding for COPD using a screening questionnaire in primary care is likely to be cost-effective in the long-term despite uncertainties in treatment effectiveness. Further knowledge of the natural history of case-found patients and the effectiveness of their management will improve confidence to implement such an approach.

Download Full-text

Cost-effectiveness of preventing depression in primary care patients

The British Journal of Psychiatry ◽

10.1192/bjp.188.4.330 ◽

2006 ◽

Vol 188 (4) ◽

pp. 330-336 ◽

Cited By ~ 72

Author(s):

Filip Smit ◽

Godelief Willemse ◽

Marc Koopmanschap ◽

Simone Onrust ◽

Pim Cuijpers ◽

...

Keyword(s):

Primary Care ◽

Cost Effectiveness ◽

Depressive Disorder ◽

Usual Care ◽

Cost Effective ◽

Randomised Clinical Trial ◽

Improved Outcomes ◽

Primary Care Patients ◽

Minimal Contact ◽

The Cost

BackgroundLittle is known about the cost-effectiveness of preventing mental disorders.AimsTo study the cost-effectiveness of care as usual plus minimal contact psychotherapy relative to usual care alone in preventing depressive disorder.MethodAn economic evaluation was conducted alongside a randomised clinical trial. Primary care patients with sub-threshold depression were assigned to minimal contact psychotherapy plus usual care (n=107) or to usual care alone (n=109).ResultsPrimary care patients with sub-threshold depression benefited from minimal contact psychotherapy as it reduced the risk of developing a full-blown depressive disorder from 18% to 12%. In addition, this intervention had a 70% probability of being more cost-effective than usual care alone. A sensitivity analysis indicated the robustness of these results.ConclusionsOver 1 year adjunctive minimal contact psychotherapy improved outcomes and generated lower costs. This intervention is therefore superior to usual care alone in terms of cost-effectiveness.

Download Full-text

Improving Primary Care After Stroke (IPCAS) trial: protocol of a randomised controlled trial to evaluate a novel model of care for stroke survivors living in the community

BMJ Open ◽

10.1136/bmjopen-2019-030285 ◽

2019 ◽

Vol 9 (8) ◽

pp. e030285 ◽

Cited By ~ 2

Author(s):

Ricky Mullis ◽

Maria Raisa Jessica (Ryc) Aquino ◽

Sarah Natalie Dawson ◽

Vicki Johnson ◽

Sue Jowett ◽

...

Keyword(s):

Primary Care ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Self Management ◽

Stroke Survivors ◽

Model Of Care ◽

New Model ◽

General Practices ◽

Randomised Controlled

IntroductionSurvival after stroke is improving, leading to increased demand on primary care and community services to meet the long-term care needs of people living with stroke. No formal primary care-based holistic model of care with clinical trial evidence exists to support stroke survivors living in the community, and stroke survivors report that many of their needs are not being met. We have developed a multifactorial primary care model to address these longer term needs. We aim to evaluate the clinical and cost-effectiveness of this new model of primary care for stroke survivors compared with standard care.Methods and analysisImproving Primary Care After Stroke (IPCAS) is a two-arm cluster-randomised controlled trial with general practice as the unit of randomisation. People on the stroke registers of general practices will be invited to participate. One arm will receive the IPCAS model of care including a structured review using a checklist; a self-management programme; enhanced communication pathways between primary care and specialist services; and direct point of contact for patients. The other arm will receive usual care. We aim to recruit 920 people with stroke registered with 46 general practices. The primary endpoint is two subscales (emotion and handicap) of the Stroke Impact Scale (SIS) as coprimary outcomes at 12 months (adjusted for baseline). Secondary outcomes include: SIS Short Form, EuroQol EQ-5D-5L, ICEpop CAPability measure for Adults, Southampton Stroke Self-management Questionnaire, Health Literacy Questionnaire and medication use. Cost-effectiveness of the new model will be determined in a within-trial economic evaluation.Ethics and disseminationFavourable ethical opinion was gained from Yorkshire and the Humber-Bradford Leeds NHS Research Ethics Committee. Approval to start was given by the Health Research Authority prior to recruitment of participants at any NHS site. Data will be presented at national and international conferences and published in peer-reviewed journals. Patient and public involvement helped develop the dissemination plan.Trial registration numberNCT03353519

Download Full-text

The Cost Effectiveness of Hand Held Ultrasound Scanning for Abdominal Aortic Aneurysm in Older Males with a History of Smoking

Journal of Health Economics and Outcomes Research ◽

10.36469/9856 ◽

2013 ◽

Vol 1 (2) ◽

pp. 96-107

Author(s):

Denver Phiri ◽

Peter J. Mallow ◽

John A. Rizzo

Keyword(s):

Primary Care ◽

Cost Effectiveness ◽

Surgical Intervention ◽

Cost Effective ◽

Cost Utility ◽

Ultrasound Scanning ◽

Abdominal Aortic ◽

History Of ◽

The Cost ◽

Older Males

Objective: Abdominal aortic aneurysm (AAA) is a serious illness occurring in 1 of 20 older men. Guidelines emphasize the role of ultrasound scanning for patients at risk of AAA, yet the cost effectiveness of such scanning remains uncertain. New pocket mobile echocardiography (PME) devices may enhance the cost effectiveness of such scanning due to its low cost, ability to be used in primary care settings, and high degree of accuracy. This study performs cost utility analyses (CUAs) comparing opportunistic scanning for AAA using a PME to usual care for a hypothetical cohort of 10,000 male smokers age 65+. Methods: The study compares the incremental cost per quality-adjusted life year (QALY) gained for three alternative strategies over a 5-year time horizon. The study used a decision analytic simulation model to calculate the incremental cost utility for the different strategies. Three alternative criteria for surgical intervention were considered via scanning according to aneurysm size. These treatment strategies were compared to a control group that received no scanning. Model input values are taken from the literature. Sensitivity analysis was performed to gauge the robustness of the results. Results: Opportunistic scanning is cost effective. Indeed, when surgical intervention is limited to medium (5.0-5.4 cm) or large (≥5.5 cm) aneurysms, such scanning is dominant; that is, it costs less and increases QALYs compared to usual care. When surgical intervention is extended to small (4.0-4.9 cm) aneurysms, scanning remains cost effective ($64,156 per QALY vs. $100,000 threshold). The results are robust to alternative plausible model input values. Conclusion: These findings suggest that primary care physicians with proper training should consider PMEs as a cost effective method to opportunistically scan and manage AAA patients among older males who have a history of smoking.

Download Full-text

Cost-effectiveness of Self-managed Program Versus Usual Physiotherapy Care of Patients With Knee Osteoarthritis in Nigeria

Iranian Rehabilitation Journal ◽

10.32598/irj.19.4.1007.1 ◽

2021 ◽

Vol 19 (4) ◽

pp. 407-416

Author(s):

Wasila Habib ◽

◽

Adedapo Wasiu Awotidebe ◽

Keyword(s):

Cost Effectiveness ◽

Knee Osteoarthritis ◽

Usual Care ◽

Usual Care Group ◽

Cost Effective ◽

The Self ◽

Self Management ◽

Care Group ◽

Physiotherapy Treatment

Objectives: This study aims to compare, from a patient’s perspective, the cost-effectiveness between a self-managed program and usual physiotherapy care in treating knee osteoarthritis. Methods: The study participants were assigned into two groups: group I received a weekly physiotherapy treatment plus instructions on self-management skills in goal setting, pain management, exercise, healthy eating, and dealing with fatigue (self-managed group); group II had a physiotherapy session three times a week (usual care group). The osteoarthritis cost and consequence and European quality of life-5 dimension (EQ-5D) were used to generate utility scores. The health effects measure of quality-adjusted life year (QALY) was obtained, and an incremental cost-effective ratio was calculated. Cost-effectiveness was determined by plotting a cost-effectiveness plane of incremental cost against QALY obtained. Results: After 8 weeks of intervention, the self-managed group recorded more significant improvements in pain level, function, and health-related quality of life than the usual care group. Clinical consultation costs (Mean±SD NGN [Nigerian naira]=1800±979), physiotherapy treatment costs (Mean±SD NGN=4000±00), and transportation costs (Mean±SD NGN=1,940±1,150) were less for the self-managed group than the usual care group. Imaging (x-ray) and drug costs did not differ significantly between groups. The QALYs gained over the 8-week intervention period was 0.13 for the self-management group compared to 0.11 for the usual care group. Discussion: From the patient’s perspective, a self-managed program was cost-effective and cheaper for healthcare resource use. Physiotherapists may adopt the program to reduce out-of-pocket expenses for patients with knee osteoarthritis.

Download Full-text

Effects of technology-enabled blood pressure monitoring in primary care: A quasi-experimental trial

Journal of Telemedicine and Telecare ◽

10.1177/1357633x211031780 ◽

2021 ◽

pp. 1357633X2110317

Author(s):

Valerie HY Teo ◽

Sok Huang Teo ◽

Sarah M Burkill ◽

Yi Wang ◽

Evelyn AL Chew ◽

...

Keyword(s):

Blood Pressure ◽

Primary Care ◽

Health Care ◽

Cost Effectiveness ◽

Usual Care ◽

Intervention Group ◽

Cost Effective ◽

Health Care Team ◽

Home Blood Pressure ◽

Quasi Experimental

Introduction Technology to enhance hypertension management is increasingly used in primary care; however, it has not been evaluated in an Asian primary care setting. We aimed to understand the clinical impact and cost-effectiveness of a technology-enabled home blood pressure monitor when deployed in primary care, and patients’ perspectives about the technology. Methods A quasi-experimental cohort study was conducted in a polyclinic in Singapore. In total, 120 patients with hypertension were assigned to the telemonitoring intervention group. Patients received a home blood pressure device connected to the clinical care team's dashboard through a mobile gateway. Tele-consultations and nurse-led tele-support were carried out using established clinical protocols. In total, 120 patients assigned to the control group continued to receive usual care in the polyclinic. Clinical outcomes, cost-effectiveness, and patient satisfaction were measured 6 months after recruitment. Results In total, 217 patients completed 6 months of follow-up. Telemonitoring intervention patients had significantly increased odds of having controlled blood pressure by a factor of 2.69 ( p = 0.01), with the greatest improvement in those whose blood pressure was uncontrolled at baseline ( p < 0.05). The incremental cost-effectiveness ratios for all patients was S$23,935.14/quality-adjusted life year (<1 gross domestic product per capita), which was very cost-effective based on World Health Organization cost-effectiveness thresholds. There was greater satisfaction in telemonitoring intervention group relating to the convenience of recording and sharing blood pressure measurements with the health care team, consultation advice received, understanding by the health care team of their condition, and were more motivated to monitor their blood pressure. Discussion Telemonitoring with tele-consultation improved blood pressure control and was more cost-effective than usual care. Patients receiving telemonitoring intervention were also more motivated and satisfied with their care.

Download Full-text

Evaluation of FindMyApps: protocol for a randomized controlled trial of the effectiveness and cost-effectiveness of a tablet-based intervention to improve self-management and social participation of community-dwelling people with mild dementia, compared to usual tablet use

BMC Geriatrics ◽

10.1186/s12877-021-02038-8 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

David Peter Neal ◽

Yvonne J. F. Kerkhof ◽

Teake P. Ettema ◽

Majon Muller ◽

Judith Bosmans ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Cost Effectiveness ◽

Usual Care ◽

Social Participation ◽

Controlled Trial ◽

Community Dwelling ◽

Self Management ◽

Tablet Computer ◽

Randomized Controlled ◽

People With Dementia

Abstract Background For the rising number of people living with dementia, cost-effective community-based interventions to support psychosocial care are needed. The FindMyApps intervention has been developed with and for people with dementia and their caregivers, to help them use tablets to facilitate self-management and engagement in meaningful social activities. A feasibility study and exploratory pilot trial evaluating FindMyApps have been carried out. This definitive trial further evaluates the effectiveness of the intervention and, for the first time, the cost-effectiveness. Methods A randomized controlled non-blinded single-center two-arm superiority trial will be conducted. Community-dwelling people with Mild Cognitive Impairment (MCI), or dementia with a Mini Mental-State Examination (MMSE) of > 17 and < 26, or Global Deterioration Scale 3 or 4, with an informal caregiver and access to a wireless internet connection will be included. In total, 150 patient-caregiver dyads will be randomly allocated to receive either usual care (control arm – tablet computer; n = 75 dyads) or usual care and the FindMyApps intervention (experimental arm – tablet computer and FindMyApps; n = 75 dyads). The primary outcomes are: for people with dementia, self-management and social participation; for caregivers, sense of competence. In addition to a main effect analysis, a cost-effectiveness analysis will be performed. In line with MRC guidance for evaluation of complex interventions a process evaluation will also be undertaken. Discussion Results of the trial are expected to be available in 2023 and will be submitted for publication in international peer-reviewed scientific journals, in addition to conference presentations and reporting via the EU Marie Sklodowska-Curie DISTINCT ITN network. By providing evidence for or against the effectiveness and cost-effectiveness of the FindMyApps intervention, the results of the trial will influence national implementation of FindMyApps. We hope that the results of the trial will further stimulate research and development at the intersection of technology and psycho-social care in dementia. We hope to further demonstrate that the randomized controlled trial is a valuable and feasible means of evaluating new digital technologies, to stimulate further high-quality research in this growing field. Trial registration number Netherlands Trial Register: NL8157; registered 15th November 2019.

Download Full-text