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

November 16, 2011 updated by: Radboud University Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

135

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Nijmegen, Netherlands, PO Box 9101, 6500 HB
        • Memory Clinic and Geriatic Department Radboud University Nijmegen Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

Alzheimer's Association
VCVGZ Fund;
Dutch Occupational Therapy Association

Investigators

  • Principal Investigator: Marcel GM Olde-Rikkert, PhD, MD, Department of Geriatrics Radboud University Nijmegen Medical Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Study Completion

February 1, 2005

Study Registration Dates

First Submitted

February 21, 2006

First Submitted That Met QC Criteria

February 21, 2006

First Posted (Estimate)

February 22, 2006

Study Record Updates

Last Update Posted (Estimate)

November 17, 2011

Last Update Submitted That Met QC Criteria

November 16, 2011

Last Verified

February 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EDO project
  • Grant V-1999-023.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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