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Supporting Caregivers of Persons With Dementia: A Pilot Study

Primary Purpose

Alzheimer Disease, Dementia

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Education Control
Environmental Skill Building
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Randomized control trial, Dementia caregivers, Occupational Therapy, Caregivers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • McMaster University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Education Control

Environmental Skill Building

Arm Description

Outcomes

Primary Outcome Measures

Revised Memory and Behavior Problem Checklist

Secondary Outcome Measures

Disability Assessment for Dementia
Number of caregiving assistance hours
Short Zarit Burden Interview
Task Management Strategy Index
Perceived Change Scale

Full Information

First Posted
May 26, 2009
Last Updated
April 6, 2015
Sponsor
McMaster University
Collaborators
Alzheimer Society of Canada
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1. Study Identification

Unique Protocol Identification Number
NCT00908492
Brief Title
Supporting Caregivers of Persons With Dementia: A Pilot Study
Official Title
Pilot Study of the Environmental Skill Building Program for Dementia Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University
Collaborators
Alzheimer Society of Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Dementia
Keywords
Randomized control trial, Dementia caregivers, Occupational Therapy, Caregivers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Education Control
Arm Type
Active Comparator
Arm Title
Environmental Skill Building
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Education Control
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Environmental Skill Building
Intervention Description
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 Measure Information:
Title
Revised Memory and Behavior Problem Checklist
Time Frame
0, 6, 9 months
Secondary Outcome Measure Information:
Title
Disability Assessment for Dementia
Time Frame
0, 6, 9 months
Title
Number of caregiving assistance hours
Time Frame
0, 6, 9 months
Title
Short Zarit Burden Interview
Time Frame
0, 6, 9 months
Title
Task Management Strategy Index
Time Frame
0, 6, 9 months
Title
Perceived Change Scale
Time Frame
0, 6, 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lori Letts
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 1C7
Country
Canada

12. IPD Sharing Statement

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Supporting Caregivers of Persons With Dementia: A Pilot Study

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