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Supporting Caregivers of Persons With Dementia: A Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00908492
Recruitment Status : Completed
First Posted : May 27, 2009
Last Update Posted : April 7, 2015
Alzheimer Society of Canada
Information provided by (Responsible Party):
Lori Letts, McMaster University

Brief Summary:
The purpose of this study is to pilot the home Environmental Skill-Building Program (ESP) and an educational control intervention with persons with dementia and their caregivers (n=40) in preparation for a larger double-blind randomized controlled trial. Caregivers of persons with dementia often deal with difficult behaviors. The ESP is an occupational therapy intervention that helps caregivers adapt to their environment and build care-giving skills. The areas addressed include changes to the home set-up, adaptive equipment, instruction in strategies of problem-solving, energy conservation, safe task performance, and fall recovery techniques. A trial is needed with methodological rigor and to determine if the intervention is feasible in the Canadian health care system. Results will contribute to understanding how caregivers and people with dementia can be supported in their home environments.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Dementia Behavioral: Education Control Behavioral: Environmental Skill Building Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study of the Environmental Skill Building Program for Dementia Caregivers
Study Start Date : November 2009
Actual Primary Completion Date : August 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

Arm Intervention/treatment
Active Comparator: Education Control Behavioral: Education Control
Caregiver participants are provided with information about caregiver stress and discuss it individually with an interventionist who visits the home. The control intervention involves 5 visits over 6 months.

Experimental: Environmental Skill Building Behavioral: Environmental Skill Building
The ESP intervention addresses home modifications and training in their use, instruction in strategies of problem-solving, energy conservation, safe task performance, fall recovery techniques, and balance and muscle strength training. Intervention is individualized for target areas identified in the initial client assessment and caregiver interview. The intervention involves using a problem solving approach and client-centred focus and the intervention assessment tools are individualized measures which determine the goals identified by the caregiver. It involves 5 visits over 6 months.

Primary Outcome Measures :
  1. Revised Memory and Behavior Problem Checklist [ Time Frame: 0, 6, 9 months ]

Secondary Outcome Measures :
  1. Disability Assessment for Dementia [ Time Frame: 0, 6, 9 months ]
  2. Number of caregiving assistance hours [ Time Frame: 0, 6, 9 months ]
  3. Short Zarit Burden Interview [ Time Frame: 0, 6, 9 months ]
  4. Task Management Strategy Index [ Time Frame: 0, 6, 9 months ]
  5. Perceived Change Scale [ Time Frame: 0, 6, 9 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • The caregiver must be the primary caregiver
  • Caregiver reports that the care recipient has at least one limitation in basic activities of daily living (ADL) or two dependencies in instrumental activities of daily living (IADLs)
  • The caregiver must:

    • provide at least 2 hours of care per day
    • be caregiving for at least 6 months and
    • be at least 21 years of age
  • The care recipients need to have a diagnosis of dementia

Exclusion Criteria:

  • Caregiver:

    • does not live with the care recipient
    • has poor health (undergoing treatments for cancer, hospitalized more than three times in past year)
    • planning to place care recipient in long term care within the next year
  • Care recipients who are confined to bed most of the day or are minimally-responsive to touch or the environment are excluded

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 identifier (NCT number): NCT00908492

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Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8S 1C7
Sponsors and Collaborators
McMaster University
Alzheimer Society of Canada
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Principal Investigator: Lori Letts McMaster University
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Responsible Party: Lori Letts, Associate Professor, McMaster University Identifier: NCT00908492    
Other Study ID Numbers: ASC1050
First Posted: May 27, 2009    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2015
Keywords provided by Lori Letts, McMaster University:
Randomized control trial
Dementia caregivers
Occupational Therapy
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders