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

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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00295152
Enrollment
135
Registered
2006-02-22
Start date
2001-04-30
Completion date
2005-02-28
Last updated
2011-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Community Occupational Therapy, Dementia Patients, Primary Caregivers of Dementia Patients

Keywords

elderly/aged, occupational therapy, daily activities, caregivers, sense of competence

Brief 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.

Detailed 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.

Interventions

BEHAVIORALcommunity occupational therapy in dementia

Sponsors

Alzheimer's Association
CollaboratorOTHER
VCVGZ Fund;
CollaboratorUNKNOWN
Dutch Occupational Therapy Association
CollaboratorUNKNOWN
Radboud University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026