Supporting Caregivers of Persons With Dementia: A Pilot Study

Phase 2

Completed

• Conditions: Dementia; Alzheimer Disease
• Interventions: Behavioral: Education Control; Behavioral: Environmental Skill Building

• Registration Number: NCT00908492
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-05-26
• Study First Submitted QC: 2009-05-26
• Study First Posted: 2009-05-27
• Study Start: 2009-11
• Primary Completion: 2011-08
• Study Completion: 2011-09
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-06
• Last Update Posted: 2015-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education Control	Education Control	-
Environmental Skill Building	Environmental Skill Building	-

Primary Outcome Measures

Name	Time	Method
Revised Memory and Behavior Problem Checklist	0, 6, 9 months

Secondary Outcome Measures

Name	Time	Method
Disability Assessment for Dementia	0, 6, 9 months
Perceived Change Scale	0, 6, 9 months
Task Management Strategy Index	0, 6, 9 months
Number of caregiving assistance hours	0, 6, 9 months
Short Zarit Burden Interview	0, 6, 9 months

Trial Locations

Locations (1)

McMaster University; 🇨🇦 Hamilton, Ontario, Canada