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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2006 by Radboud University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Alzheimer's Association
VCVGZ Fund;
Dutch Occupational Therapy Association
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00295152
First received: February 21, 2006
Last updated: November 16, 2011
Last verified: February 2006
  Purpose

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.


Condition Intervention
Community Occupational Therapy
Dementia Patients
Primary Caregivers of Dementia Patients
Behavioral: community occupational therapy in dementia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 135
Study Start Date: April 2001
Estimated Study Completion Date: February 2005
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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00295152

Locations
Netherlands
Memory Clinic and Geriatic Department Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, PO Box 9101, 6500 HB
Sponsors and Collaborators
Radboud University
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
  More Information

Publications:
Graff MJL, et al.Occupational therapy at home for older individuals with mild to moderate cognitive impairments and their primary caregivers: a pilot study. Occupational Therapy Journal of Research 23, 155-163, 2003.
Graff MJL, Melick van MBM. The development, testing and implementation of an occupational therapy guideline. The guideline for the OT diagnosis and treatment of older persons with cognitive impairments. Ducth Occupational Therapy Journal 28, 169-174, 2000.
Melick van MBM, Graff MJL. Occupational therapy for geriatric patients. The guideline for occupational therapy in geriatric patients with mild to moderate cognitive impairments. Dutch Journal of Occupational Therapy 28, 176-181, 2000

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00295152     History of Changes
Other Study ID Numbers: EDO project, Grant V-1999-023.
Study First Received: February 21, 2006
Last Updated: November 16, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
elderly/aged
occupational therapy
daily activities
caregivers
sense of competence

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 23, 2014