Supporting Caregivers of Persons With Dementia: A Pilot Study

Pilot Study of the Environmental Skill Building Program for Dementia Caregivers

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.

Study Overview

• Status: Completed
• Conditions: Dementia; Alzheimer Disease
• Intervention / Treatment: Behavioral: Education Control; Behavioral: Environmental Skill Building

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S 1C7
      • McMaster University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Revised Memory and Behavior Problem Checklist	0, 6, 9 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: Alzheimer Society of Canada
• Investigators: Principal Investigator: Lori Letts, McMaster University

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: May 26, 2009
• First Submitted That Met QC Criteria: May 26, 2009
• First Posted (Estimate): May 27, 2009

Study Record Updates

• Last Update Posted (Estimate): April 7, 2015
• Last Update Submitted That Met QC Criteria: April 6, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Occupational Therapy; Caregivers; Randomized control trial; Dementia caregivers
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Dementia; Alzheimer Disease
• Other Study ID Numbers: ASC1050