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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 Medical Center.
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 Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Community Occupational Therapy Dementia Patients Primary Caregivers of Dementia Patients Behavioral: community occupational therapy in dementia Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
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.
Study Start Date : April 2001
Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

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

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

Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00295152


Locations
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Netherlands
Memory Clinic and Geriatic Department Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, PO Box 9101, 6500 HB
Sponsors and Collaborators
Radboud University Medical Center
Alzheimer's Association
VCVGZ Fund;
Dutch Occupational Therapy Association
Investigators
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Principal Investigator: Marcel GM Olde-Rikkert, PhD, MD Department of Geriatrics Radboud University Nijmegen Medical Centre
More Information
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Publications of Results:
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
Graff MJL, et al. How can occupational therapy improve the daily performance and communication of an older patient with dementia and his primary caregiver: a case study. Dementia: the journal of social research and practice. 2006. In press.

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00295152    
Other Study ID Numbers: EDO project
Grant V-1999-023.
First Posted: February 22, 2006    Key Record Dates
Last Update Posted: November 17, 2011
Last Verified: February 2006
Keywords provided by Radboud University Medical Center:
elderly/aged
occupational therapy
daily activities
caregivers
sense of competence
Additional relevant MeSH terms:
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Dementia
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases