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Supporting Caregivers of Persons With Dementia: A Pilot Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by McMaster University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Alzheimer Society of Canada
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00908492
First received: May 26, 2009
Last updated: May 11, 2011
Last verified: May 2011
History of Changes
  Purpose

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 Intervention Phase
Alzheimer Disease
Dementia
 Behavioral: Active control
Behavioral: Environmental Skill Building Program
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study of the Environmental Skill Building Program for Dementia Caregivers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Revised Memory and Behavior Problem Checklist [ Time Frame: 0, 6, 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disability Assessment for Dementia [ Time Frame: 0, 6, 9 months ] [ Designated as safety issue: No ]
  • Number of caregiving assistance hours [ Time Frame: 0, 6, 9 months ] [ Designated as safety issue: No ]
  • Short Zarit Burden Interview [ Time Frame: 0, 6, 9 months ] [ Designated as safety issue: No ]
  • Task Management Strategy Index [ Time Frame: 0, 6, 9 months ] [ Designated as safety issue: No ]
  • Perceived Change Scale [ Time Frame: 0, 6, 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Education Control Behavioral: Active 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 Program
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00908492

Locations
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8S 1C7
Sponsors and Collaborators
McMaster University
Alzheimer Society of Canada
  More Information

No publications provided

Responsible Party: Lori Letts, Associate Professor, McMaster University
ClinicalTrials.gov Identifier: NCT00908492     History of Changes
Other Study ID Numbers: ASC1050
Study First Received: May 26, 2009
Last Updated: May 11, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
Randomized control trial
Dementia caregivers
Occupational Therapy
Caregivers

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

ClinicalTrials.gov processed this record on May 19, 2013