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

Study Overview
=================
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
-----------------
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. Methods 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). 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). 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. 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) 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. 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.

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.

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

Intervention / Treatment
-----------------
* Behavioral: community occupational therapy in dementia


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: community occupational therapy in dementia|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1.process skills scores of the patients on the Assessment of Motor and Process Skills (AMPS); |  |  | 
| 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). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients: |  |  | 
| 1. motor skills scores on the AMPS |  |  | 
| 2. initiative in performing daily activities on the IDDD |  |  | 
| 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: |  |  | 
| 1. mastery skills scored on the Mastery Scale |  |  | 
| 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 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
caregivers, elderly/aged, occupational therapy, daily activities, sense of competence