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Supporting Caregivers of Persons With Dementia: A Pilot Study

Pilot Study of the Environmental Skill Building Program for Dementia Caregivers

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00908492
Enrollment
38
Registered
2009-05-27
Start date
2009-11-30
Completion date
2011-09-30
Last updated
2015-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Dementia

Keywords

Randomized control trial, Dementia caregivers, Occupational Therapy, Caregivers

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.

Interventions

BEHAVIORALEducation 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.

BEHAVIORALEnvironmental 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.

Sponsors

Alzheimer Society of Canada
CollaboratorOTHER
McMaster University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Revised Memory and Behavior Problem Checklist0, 6, 9 months

Secondary

MeasureTime frame
Disability Assessment for Dementia0, 6, 9 months
Number of caregiving assistance hours0, 6, 9 months
Short Zarit Burden Interview0, 6, 9 months
Task Management Strategy Index0, 6, 9 months
Perceived Change Scale0, 6, 9 months

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026