Community Occupational Therapy Clinical Trial
Official title:
Effects of Community Occupational Therapy on the Daily Performance of Older Patients With Mild to Moderate Dementia and on the Sense of Competence of Their Primary Caregivers.
The purpose of this study is to determine the effects of community occupational therapy in older patients with mild ot moderate dementia and their primary caregivers.
1. Objective To determine the effects of community occupational therapy on the daily
performance of older patients with mild to moderate dementia and the sense of
competence of their primary caregivers.
2. Methods
1. design: a randomized controlled single-blind design is used with 3 measurement
moments. We measure at baseline (before start of OT intervention), after 6 weeks
(the effect measurement)and after 3 months after baseline (follow-up measurement).
2. patients: 135 patients and their primary caregivers are needed to determine
effects on the primary outcome measures of this intervention, with a power of 80%
and alpha = 0.05/3. This power calculation is based on the outcomes of a pilot
study (Graff, et al., 2003).
3. intervention: 5 weeks client-centered community occupational therapy directed at
both patients and primary caregivers using an OT guideline.The control group
receives no OT intervention, but usual care.
4. main outcome measures are: Assessment of Motor and Process Skills, Interview in
Deterioration of Daily Activities in Dementia (IDDD)and Sense of Competence
Questionnaire (SCQ)
5. Analysis: analyses of covariance on intention-to-treat basis (Last Observation
Carried Forward (LCOF))will be used to determine the effects of community OT on
the daily performance of older patients with dementia and the sense of competence
of their primary caregivers. Also secondary patients'and caregivers' health
outcomes will be analyzed by analyses of covariance on intention-to-treat basis.
6. Cost-effectiveness: the costs of this OT intervention will also be determined and
a cost-effectiveness analysis will be carried out.
3)Results: Results at baseline, at 6 weeks and at 3 months follow-up on primary
outcome measures and on patients' and caregivers' secondary health outcomes and
also the cost effectiveness of this intervention, will be analyzed and described
in international publications.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind, Primary Purpose: Treatment