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Supporting Caregivers of Persons With Dementia: A Pilot Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00908492
First Posted: May 27, 2009
Last Update Posted: October 12, 2017
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.
Collaborator:
Alzheimer Society of Canada
Information provided by (Responsible Party):
Lori Letts, McMaster University
  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: Education Control Behavioral: Environmental Skill Building Phase 2 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Lori Letts, McMaster University:

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

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

Enrollment: 38
Study Start Date: November 2009
Study Completion Date: September 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT00908492


Locations
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8S 1C7
Sponsors and Collaborators
McMaster University
Alzheimer Society of Canada
Investigators
Principal Investigator: Lori Letts McMaster University
  More Information

Responsible Party: Lori Letts, Associate Professor, McMaster University
ClinicalTrials.gov Identifier: NCT00908492     History of Changes
Other Study ID Numbers: ASC1050
First Submitted: May 26, 2009
First Posted: May 27, 2009
Last Update Posted: October 12, 2017
Last Verified: April 2015

Keywords provided by Lori Letts, 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
Neurocognitive Disorders
Mental Disorders