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WHEDA study: effectiveness of occupational therapy at home for older people with dementia and their caregivers--the design of a pragmatic randomised controlled trial evaluating a Dutch programme in seven German centres.

Abstract

BACKGROUND

A recent Dutch mono-centre randomised controlled trial has shown that occupational therapy improves daily functioning in dementia. The aim of this present study is to compare the effects of the Dutch community occupational therapy programme with a community occupational therapy consultation on daily functioning in older people with mild or moderate dementia and their primary caregivers in a German multi-centre context.

METHODS/DESIGN

A multi-centre single blind randomised controlled trial design is being used in seven health care centres (neurological, psychiatric and for older people) in urban regions. Patients are 1:1 randomised to treatment or control group. Assessors are blind to group assignment and perform measurements on both groups at baseline, directly after intervention at 6 weeks and at 16, 26 and 52 weeks follow-up. A sample of 140 community dwelling older people (aged >65 years) with mild or moderate dementia and their primary caregivers is planned. The experimental intervention consists of an evidence-based community occupational therapy programme including 10 sessions occupational therapy at home. The control intervention consists of one community occupational therapy consultation based on information material of the Alzheimer Society. Providers of both interventions are occupational therapists experienced in treatment of cognitively impaired older people and trained in both programmes. 'Community' indicates that occupational therapy intervention occurs in the person's own home. The primary outcome is patients' daily functioning assessed with the performance scale of the Interview for Deterioration in Daily Living Activities in Dementia and video tapes of daily activities rated by external raters blind to group assignment using the Perceive, Recall, Plan and Perform System of Task Analysis. Secondary outcomes are patients' and caregivers' quality of life, mood and satisfaction with treatment; the caregiver's sense of competence, caregiver's diary (medication, resource utilisation, time of informal care); and the incidence of long-term institutionalisation. Process evaluation is performed by questionnaires and focus group discussion.

DISCUSSION

The transfer from the Dutch mono-centre design to the pragmatic multi-site trial in a German context implicates several changes in design issues including differences in recruitment time, training of interventionists and active control group treatment.The study is registered under DRKS00000053 at the German register of clinical trials, which is connected to the International Clinical Trials Registry Platform.

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  • Authors+Show Affiliations

    ,

    Department of Occupational Therapy, Centre of Geriatric Medicine and Gerontology Freiburg, University Hospital Freiburg, Germany. sebastian.voigt@uniklinik-freiburg.de

    , , , , ,

    Source

    BMC geriatrics 9: 2009 Oct 02 pg 44

    MeSH

    Aged
    Caregivers
    Clinical Protocols
    Dementia
    Germany
    Homes for the Aged
    Humans
    Netherlands
    Occupational Therapy
    Prevalence
    Research Design
    Single-Blind Method

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    19799779

    Citation

    Voigt-Radloff, Sebastian, et al. "WHEDA Study: Effectiveness of Occupational Therapy at Home for Older People With Dementia and Their Caregivers--the Design of a Pragmatic Randomised Controlled Trial Evaluating a Dutch Programme in Seven German Centres." BMC Geriatrics, vol. 9, 2009, p. 44.
    Voigt-Radloff S, Graff M, Leonhart R, et al. WHEDA study: effectiveness of occupational therapy at home for older people with dementia and their caregivers--the design of a pragmatic randomised controlled trial evaluating a Dutch programme in seven German centres. BMC Geriatr. 2009;9:44.
    Voigt-Radloff, S., Graff, M., Leonhart, R., Schornstein, K., Vernooij-Dassen, M., Olde-Rikkert, M., & Huell, M. (2009). WHEDA study: effectiveness of occupational therapy at home for older people with dementia and their caregivers--the design of a pragmatic randomised controlled trial evaluating a Dutch programme in seven German centres. BMC Geriatrics, 9, p. 44. doi:10.1186/1471-2318-9-44.
    Voigt-Radloff S, et al. WHEDA Study: Effectiveness of Occupational Therapy at Home for Older People With Dementia and Their Caregivers--the Design of a Pragmatic Randomised Controlled Trial Evaluating a Dutch Programme in Seven German Centres. BMC Geriatr. 2009 Oct 2;9:44. PubMed PMID: 19799779.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - WHEDA study: effectiveness of occupational therapy at home for older people with dementia and their caregivers--the design of a pragmatic randomised controlled trial evaluating a Dutch programme in seven German centres. AU - Voigt-Radloff,Sebastian, AU - Graff,Maud, AU - Leonhart,Rainer, AU - Schornstein,Katrin, AU - Vernooij-Dassen,Myrra, AU - Olde-Rikkert,Marcel, AU - Huell,Michael, Y1 - 2009/10/02/ PY - 2009/09/08/received PY - 2009/10/02/accepted PY - 2009/10/6/entrez PY - 2009/10/6/pubmed PY - 2010/5/25/medline SP - 44 EP - 44 JF - BMC geriatrics JO - BMC Geriatr VL - 9 N2 - BACKGROUND: A recent Dutch mono-centre randomised controlled trial has shown that occupational therapy improves daily functioning in dementia. The aim of this present study is to compare the effects of the Dutch community occupational therapy programme with a community occupational therapy consultation on daily functioning in older people with mild or moderate dementia and their primary caregivers in a German multi-centre context. METHODS/DESIGN: A multi-centre single blind randomised controlled trial design is being used in seven health care centres (neurological, psychiatric and for older people) in urban regions. Patients are 1:1 randomised to treatment or control group. Assessors are blind to group assignment and perform measurements on both groups at baseline, directly after intervention at 6 weeks and at 16, 26 and 52 weeks follow-up. A sample of 140 community dwelling older people (aged >65 years) with mild or moderate dementia and their primary caregivers is planned. The experimental intervention consists of an evidence-based community occupational therapy programme including 10 sessions occupational therapy at home. The control intervention consists of one community occupational therapy consultation based on information material of the Alzheimer Society. Providers of both interventions are occupational therapists experienced in treatment of cognitively impaired older people and trained in both programmes. 'Community' indicates that occupational therapy intervention occurs in the person's own home. The primary outcome is patients' daily functioning assessed with the performance scale of the Interview for Deterioration in Daily Living Activities in Dementia and video tapes of daily activities rated by external raters blind to group assignment using the Perceive, Recall, Plan and Perform System of Task Analysis. Secondary outcomes are patients' and caregivers' quality of life, mood and satisfaction with treatment; the caregiver's sense of competence, caregiver's diary (medication, resource utilisation, time of informal care); and the incidence of long-term institutionalisation. Process evaluation is performed by questionnaires and focus group discussion. DISCUSSION: The transfer from the Dutch mono-centre design to the pragmatic multi-site trial in a German context implicates several changes in design issues including differences in recruitment time, training of interventionists and active control group treatment.The study is registered under DRKS00000053 at the German register of clinical trials, which is connected to the International Clinical Trials Registry Platform. SN - 1471-2318 UR - https://www.unboundmedicine.com/medline/citation/19799779/WHEDA_study:_effectiveness_of_occupational_therapy_at_home_for_older_people_with_dementia_and_their_caregivers__the_design_of_a_pragmatic_randomised_controlled_trial_evaluating_a_Dutch_programme_in_seven_German_centres_ L2 - https://bmcgeriatr.biomedcentral.com/articles/10.1186/1471-2318-9-44 DB - PRIME DP - Unbound Medicine ER -