Supporting Caregivers of Persons With Dementia: A Pilot Study

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Study of the Environmental Skill Building Program for Dementia Caregivers

Conditions
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Alzheimer Disease, Dementia

Intervention / Treatment
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* Behavioral: Education Control
* Behavioral: Environmental Skill Building


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Education Control<br> | Behavioral: Education Control<br>* 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.<br>|
| Experimental: Environmental Skill Building<br> | Behavioral: Environmental Skill Building<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized control trial, Dementia caregivers, Occupational Therapy, Caregivers