Title: Valuing Active Life In Dementia (VALID)
Funder: Department of Health and Social Care

Abstract: Aims: To adapt, develop, evaluate and implement an occupation based intervention to promote independence, meaningful activity and quality of life for people with dementia and their carers living in the community. Background: Home orientated care is a key objective of the National Dementia Strategy and this study addresses the government’s commitment to dementia research. In the UK over 700,000 older people have dementia and two thirds of these live in the community. Dementia leads to deterioration in activities of daily living and reduced ability in social and functional activities. The NICE/SCIE guidelines for dementia recommend advice and skills training from an OT to help maintain independence. Individualised interventions improve family carer well-being, delay admission to care homes and reduce the risk of institutionalisation by one third. Few studies have evaluated occupational therapy (OT) for people with dementia living at home. In the Netherlands, the community occupational therapy intervention for dementia (COTID) trial (Graff et al 2006) demonstrated cost effectiveness and benefits to skills, activities of daily living (ADL), quality of life and depression in people with dementia, and to carer’s quality of life, mood and sense of competence. COTID has great potential for adoption in the UK. Research Plans: WP1: This involves adaptation and translation of the COTID guidelines for the UK and involves OTs, people with dementia and carers, the voluntary sector and a consensus conference. WP2: A UK survey of OT practice will evaluate the barriers/facilitators to implementing COTID in practice. WP3: The pilot/feasibility trial has 2 arms: COTID vs treatment as usual (TAU) with 25 people with dementia and their carers in each. All OTs will have completed training and achieved fidelty to COTID. This will also indicate recruitment rates and field test the outcome measures for time required for completion, feasibility, and applicability. WP4: Definitive RCT: A multi-centre, pragmatic, single blind randomised controled trial of COTID vs TAU for people with dementia living in community settings, who have a family carer. COTID involves 10 sessions of home based OT over 5 weeks working with the carer and person with dementia to improve skills in daily activities, and caregivers' skills and sense of competence. Assessments at baseline, 6 weeks, 12 weeks, 26 weeks (primary end point). Primary outcome: Bristol Activities of Daily Living Scale (BADLS). Secondary outcomes: Costs, quality of life, and carers quality of life. The primary analysis will be intention to treat and use the 26 week assessment of BADLS to compare the intervention and TAU groups. A sample size of 535 will have 90% power (with p = 0.05) to detect an effect size of 0.35. Qualitative data including transcripts of focus groups and interviews will be analysed using framework analysis. The primary economic evaluation will be a cost-utility analysis from an NHS and personal social services perspective. Data management, quality control, statistics/methodology support, and registration of patients, and randomisation will be managed by PRIMENT clinical trials unit. WP5: Implementation: 30 trained OTs will each implement COTID with 10 people with dementia. Basic outcomes include BADLS, QoL-AD, and SF12. This will determine feasibility and effectiveness in usual clinical practice as relevant to research, services and commissioners. A budget impact analysis will examine what the total NHS costs would be if COTID was rolled out nationally. Research Team: VALID builds on existing work by the applicants in psychosocial research, and clinical trials of complex interventions in dementia care. Research Environment: NELFT covers 4 boroughs in North East London within which around 9000+ people have dementia. It has a strong R&D Department and is well supported by North Thames DENDRON. Outputs, outcomes and impact: Website with COTID Manual/DVD and fidelity tool; Major RCT publications with evidence on clinical and cost-effectiveness; implementation details for commissioners and practice; improved skills and quality of life and for people with dementia and carers; reduced care home admissions; addresses major policy concerns of improved resource utilisation. Development of research capacity in dementia care studies leading to future innovation. Timescale: NHS Benefits begin in Year 2 - production of UK COTID manual. Potential for major policy changes and national implementation of COTID Public Involvement: There is significant involvement of carers, people with dementia and the voluntary sector throughout with two carers on the programme steering committee. Ethical Implications: Participants will generally be competent to give informed consent. The provisions of the Mental Capacity Act will be followed. Justification of resources: The costings reflect the volume of work and expertise required in this 5 year research programme.

Lay abstract: In the UK two thirds of the 700,000 people with dementia live in their own homes. Dementia leads to progressive deterioration in cognitive functioning and activities of daily living, social exclusion, and carer stress. In general it costs less to support people at home than in care homes and people with dementia and their families usually want to remain at home for as long as possible. Home orientated care is a key objective of the National Dementia Strategy and this study addresses the government’s commitment to dementia research. The NICE/SCIE guidelines for dementia highlight the importance of advice and skills training from an occupational therapist (OT) to help maintain independence at home. Few studies have evaluated occupational therapy for people with dementia living at home though it may improve functional independence and decrease carer stress, and two recent reviews of the research literature found that individualised interventions improve family carer well-being, delay admission to care homes and reduce the risk of care home admission by one third. Not enough is being done to help people cope at home, but a study in the Netherlands using community occupational therapy intervention for dementia (COTID) showed that it helped people manage at home by improving daily living skills, and supporting the carer, and COTID has great potential for adoption in the UK. We plan to conduct a research trial of COTID in the UK to see how far it is effective in the NHS in comparison to usual care. To do this we will translate and adapt COTID for the UK context and survey OTs to identify the best way to introduce COTID into practice. COTID involves 10 sessions of home based OT over 5 weeks working with the carer and person with dementia to improve skills in daily activities, and caregivers' skills. After a small pilot study we will conduct a full clinical trial in 3 centres across England to evaluate the clinical effectiveness and costs of COTID compared to usual care. Finally we will conduct a study looking at the implermentation of COTID in clinical practice. There is significant involvement of carers, people with dementia and the voluntary sector throughout with two carers on the programme steering committee. COTID could potentially have major benefits for people with dementia and their carers helping to cope better and to avoid care home admissions, and could lead to major improvements in services.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: NEUROLOGICAL