Overview

This trial is active, not recruiting.

Conditions community occupational therapy, dementia patients, primary caregivers of dementia patients
Treatment community occupational therapy in dementia
Sponsor Radboud University
Collaborator Alzheimer's Association
Start date April 2001
End date February 2005
Trial size 135 participants
Trial identifier NCT00295152, EDO project, Grant V-1999-023.

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking single blind
Primary purpose treatment

Primary Outcomes

Measure
1.process skills scores of the patients on the Assessment of Motor and Process Skills (AMPS);
time frame:
2. performance scores in daily activities of the patients on the Interview of Deterioration in Daily Activities in Dementia (IDDD);
time frame:
3. Sense of competence scores of the primary caregivers on the Sense of Competence Questionnaire (SCQ).
time frame:

Secondary Outcomes

Measure
Patients:
time frame:
1. motor skills scores on the AMPS
time frame:
2. initiative in performing daily activities on the IDDD
time frame:
3. general health scores on the General Health Questionnaire (GHQ-12)
time frame:
4.Quality of life scored on the Dementia Quality of Life Instrument (DQOL)
time frame:
5. Self-perception scores in occupational performance and satisfaction scores with this performance, scored on the Canadian Occupational Performance Measurement (COPM)
time frame:
6. Mood/depression scored on the Cornell Depression Scale (CDS)
time frame:
Caregiver:
time frame:
1. mastery skills scored on the Mastery Scale
time frame:
2. general health scores on the GHQ-12
time frame:
3. quality of life scores on the DQOL
time frame:
4. self-perception scores in occupational performance and satisfaction scores on the COPM
time frame:
5. mood/depression scores on the Center for Epidemiologic Studies Depression Scales (Ces-D)
time frame:
6. Copings skills scores on the JCS
time frame:

Eligibility Criteria

Male or female participants at least 65 years old.

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

Additional Information

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.
Principal investigator Marcel GM Olde-Rikkert, PhD, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2011.
Information provided to ClinicalTrials.gov by Radboud University.