Effects of Community Occupational Therapy in Older Patients With Dementia and Their Caregivers.

Radboud University Medical Center

Status: Unknown

Conditions: Dementia Patients; Primary Caregivers of Dementia Patients; Community Occupational Therapy

Treatments: Behavioral: community occupational therapy in dementia

Study type: Interventional

Funder types: Other

Identifiers

NCT00295152

Grant V-1999-023.

EDO project

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• aged 65 years or older
• mild to moderate dementia (MMSE 10-24)
• living in the community at maximum of 50 kilometers from the Memory Clinic
• having an informal primary caregiver who was involved in the care for the patient at least once a week

Exclusion criteria

• depression: score > 12 on the Geriatric Depression Scale
• severe behavioral or psychological symptoms in dementia (BPSD) judged by a geriatrician
• severe illnesses, judged by a geriatrician
• no OT goals, determined by the researcher or research assistant
• caregivers having severe illnesses

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind