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Community occupational therapy for people with dementia and family carers (COTiD-UK) versus treatment as usual (Valuing Active Life in Dementia [VALID] programme): study protocol for a randomised controlled trial.

Abstract

BACKGROUND

A community-based occupational therapy intervention for people with mild to moderate dementia and their family carers (Community Occupational Therapy in Dementia (COTiD)) was found clinically and cost effective in the Netherlands but not in Germany. This highlights the need to adapt and implement complex interventions to specific national contexts. The current trial aims to evaluate the United Kingdom-adapted occupational therapy intervention for people with mild to moderate dementia and their family carers living in the community (COTiD-UK) compared with treatment as usual.

METHODS/DESIGN

This study is a multi-centre, parallel-group, pragmatic randomised trial with internal pilot. We aim to allocate 480 pairs, with each pair comprising a person with mild to moderate dementia and a family carer, who provides at least 4 hours of practical support per week, at random between COTiD-UK and treatment as usual. We shall assess participants at baseline, 12 and 26 weeks, and by telephone at 52 and 78 weeks (first 40% of recruits only) after randomisation. The primary outcome measure is the Bristol Activities of Daily Living Scale (BADLS) at 26 weeks. Secondary outcome measures will include quality of life, mood, and resource use. To assess intervention delivery, and client experience, we shall collect qualitative data via audio recordings of COTiD-UK sessions and conduct semi-structured interviews with pairs and occupational therapists.

DISCUSSION

COTiD-UK is an evidence-based person-centred intervention that reflects the current priority to enable people with dementia to remain in their own homes by improving their capabilities whilst reducing carer burden. If COTiD-UK is clinically and cost effective, this has major implications for the future delivery of dementia services across the UK.

TRIAL REGISTRATION

Current Controlled Trials ISRCTN10748953 Date of registration: 18 September 2014.

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  • Authors+Show Affiliations

    ,

    Division of Psychiatry, Faculty of Brain Sciences, University College London, London, UK. j.wenborn@ucl.ac.uk. Research & Development Department, Goodmayes Hospital, North East London NHS Foundation Trust, Essex, IG3 8XJ, UK. j.wenborn@ucl.ac.uk.

    ,

    Department of Occupational Therapy, National University of Ireland, Galway, Ireland. sinead.hynes@nuigalway.ie.

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    Faculty of Health and Social Care, University of Hull, Hull, UK. e.d.moniz-cook@hull.ac.uk.

    ,

    School of Health and Related Research, University of Sheffield, Sheffield, UK. g.a.mountain@sheffield.ac.uk.

    ,

    School of Health Sciences, University of East Anglia, Norwich, UK. f.poland@uea.ac.uk.

    ,

    Priment Clinical Trials Unit, Division of Psychiatry, Faculty of Brain Sciences, University College London, London, UK. michael.king@ucl.ac.uk.

    ,

    Department of Statistical Science and Priment Clinical Trials Unit, University College London, London, UK. r.omar@ucl.ac.uk.

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    Department of Applied Health Research, University College London, London, UK. steve.morris@ucl.ac.uk.

    ,

    Department of IQ Healthcare; Kalorama Foundation, Radboud University Medical Center (Radboudumc), Nijmegen, The Netherlands. m.vernooij-dassen@iq.umcn.nl.

    ,

    PSSRU, Faculty of Medical and Human Sciences, University of Manchester, Manchester, UK. david.j.challis@manchester.ac.uk.

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    Department of Clinical, Educational and Health Psychology, University College London, London, UK. s.michie@ucl.ac.uk.

    ,

    Swansea Trials Unit, College of Medicine, Swansea University, Swansea, UK. i.t.russell@swansea.ac.uk.

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    Division of Health and Social Care Research, King's College, London, UK. catherine.sackley@kcl.ac.uk.

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    Department of Rehabilitation and Scientific Institute for Quality of Healthcare-Radboudumc Alzheimer Centre, Radboud University Medical Center (Radboudumc), Donders Institute for Cognition, Brain and Behaviour, Nijmegen, The Netherlands. m.graff@iq.umcn.nl.

    ,

    Department of Statistical Science and Priment Clinical Trials Unit, University College London, London, UK. a.o'keeffe@ucl.ac.uk.

    ,

    Research & Development Department, Goodmayes Hospital, North East London NHS Foundation Trust, Essex, IG3 8XJ, UK. nadia.crellin@nelft.nhs.uk.

    Institute of Mental Health, University of Nottingham, Nottingham, UK. m.orrell@nottingham.ac.uk.

    Source

    Trials 17: 2016 Feb 03 pg 65

    MeSH

    Caregivers
    Clinical Protocols
    Data Interpretation, Statistical
    Dementia
    Humans
    Informed Consent
    Occupational Therapy
    Outcome Assessment (Health Care)
    Quality of Life
    Residence Characteristics
    Sample Size
    Single-Blind Method

    Pub Type(s)

    Comparative Study
    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    26841799

    Citation

    Wenborn, Jennifer, et al. "Community Occupational Therapy for People With Dementia and Family Carers (COTiD-UK) Versus Treatment as Usual (Valuing Active Life in Dementia [VALID] Programme): Study Protocol for a Randomised Controlled Trial." Trials, vol. 17, 2016, p. 65.
    Wenborn J, Hynes S, Moniz-Cook E, et al. Community occupational therapy for people with dementia and family carers (COTiD-UK) versus treatment as usual (Valuing Active Life in Dementia [VALID] programme): study protocol for a randomised controlled trial. Trials. 2016;17:65.
    Wenborn, J., Hynes, S., Moniz-Cook, E., Mountain, G., Poland, F., King, M., ... Orrell, M. (2016). Community occupational therapy for people with dementia and family carers (COTiD-UK) versus treatment as usual (Valuing Active Life in Dementia [VALID] programme): study protocol for a randomised controlled trial. Trials, 17, p. 65. doi:10.1186/s13063-015-1150-y.
    Wenborn J, et al. Community Occupational Therapy for People With Dementia and Family Carers (COTiD-UK) Versus Treatment as Usual (Valuing Active Life in Dementia [VALID] Programme): Study Protocol for a Randomised Controlled Trial. Trials. 2016 Feb 3;17:65. PubMed PMID: 26841799.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Community occupational therapy for people with dementia and family carers (COTiD-UK) versus treatment as usual (Valuing Active Life in Dementia [VALID] programme): study protocol for a randomised controlled trial. AU - Wenborn,Jennifer, AU - Hynes,Sinéad, AU - Moniz-Cook,Esme, AU - Mountain,Gail, AU - Poland,Fiona, AU - King,Michael, AU - Omar,Rumana, AU - Morris,Steven, AU - Vernooij-Dassen,Myrra, AU - Challis,David, AU - Michie,Susan, AU - Russell,Ian, AU - Sackley,Catherine, AU - Graff,Maud, AU - O'Keeffe,Aidan, AU - Crellin,Nadia, AU - Orrell,Martin, Y1 - 2016/02/03/ PY - 2015/11/02/received PY - 2015/12/30/accepted PY - 2016/2/5/entrez PY - 2016/2/5/pubmed PY - 2016/12/15/medline SP - 65 EP - 65 JF - Trials JO - Trials VL - 17 N2 - BACKGROUND: A community-based occupational therapy intervention for people with mild to moderate dementia and their family carers (Community Occupational Therapy in Dementia (COTiD)) was found clinically and cost effective in the Netherlands but not in Germany. This highlights the need to adapt and implement complex interventions to specific national contexts. The current trial aims to evaluate the United Kingdom-adapted occupational therapy intervention for people with mild to moderate dementia and their family carers living in the community (COTiD-UK) compared with treatment as usual. METHODS/DESIGN: This study is a multi-centre, parallel-group, pragmatic randomised trial with internal pilot. We aim to allocate 480 pairs, with each pair comprising a person with mild to moderate dementia and a family carer, who provides at least 4 hours of practical support per week, at random between COTiD-UK and treatment as usual. We shall assess participants at baseline, 12 and 26 weeks, and by telephone at 52 and 78 weeks (first 40% of recruits only) after randomisation. The primary outcome measure is the Bristol Activities of Daily Living Scale (BADLS) at 26 weeks. Secondary outcome measures will include quality of life, mood, and resource use. To assess intervention delivery, and client experience, we shall collect qualitative data via audio recordings of COTiD-UK sessions and conduct semi-structured interviews with pairs and occupational therapists. DISCUSSION: COTiD-UK is an evidence-based person-centred intervention that reflects the current priority to enable people with dementia to remain in their own homes by improving their capabilities whilst reducing carer burden. If COTiD-UK is clinically and cost effective, this has major implications for the future delivery of dementia services across the UK. TRIAL REGISTRATION: Current Controlled Trials ISRCTN10748953 Date of registration: 18 September 2014. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/26841799/Community_occupational_therapy_for_people_with_dementia_and_family_carers__COTiD_UK__versus_treatment_as_usual__Valuing_Active_Life_in_Dementia_[VALID]_programme_:_study_protocol_for_a_randomised_controlled_trial_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-015-1150-y DB - PRIME DP - Unbound Medicine ER -