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

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ClinicalTrials.gov Identifier: NCT00295152
Recruitment Status : Unknown
Verified February 2006 by Radboud University.
Recruitment status was:  Active, not recruiting
First Posted : February 22, 2006
Last Update Posted : November 17, 2011
Sponsor:
Collaborators:
Alzheimer's Association
VCVGZ Fund;
Dutch Occupational Therapy Association
Information provided by:
Radboud University

Tracking Information
First Submitted Date  ICMJE February 21, 2006
First Posted Date  ICMJE February 22, 2006
Last Update Posted Date November 17, 2011
Study Start Date  ICMJE April 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2006)
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2006)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Community Occupational Therapy in Older Patients With Dementia and Their Caregivers.
Official Title  ICMJE 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE
  • Community Occupational Therapy
  • Dementia Patients
  • Primary Caregivers of Dementia Patients
Intervention  ICMJE Behavioral: community occupational therapy in dementia
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: February 21, 2006)
135
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE February 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00295152
Other Study ID Numbers  ICMJE EDO project
Grant V-1999-023.
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Radboud University
Collaborators  ICMJE
  • Alzheimer's Association
  • VCVGZ Fund;
  • Dutch Occupational Therapy Association
Investigators  ICMJE
Principal Investigator: Marcel GM Olde-Rikkert, PhD, MD Department of Geriatrics Radboud University Nijmegen Medical Centre
PRS Account Radboud University
Verification Date February 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP