Supporting Caregivers of Persons With Dementia: A Pilot Study

Alzheimer Disease Clinical Trial

Official title:

Pilot Study of the Environmental Skill Building Program for Dementia Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00908492
• Other study ID #: ASC1050
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 26, 2009
• Last updated: April 6, 2015
• Start date: November 2009
• Est. completion date: September 2011

Study information

• Verified date: April 2015
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: September 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Alzheimer Society of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Revised Memory and Behavior Problem Checklist		0, 6, 9 months
Secondary	Disability Assessment for Dementia		0, 6, 9 months
Secondary	Number of caregiving assistance hours		0, 6, 9 months
Secondary	Short Zarit Burden Interview		0, 6, 9 months
Secondary	Task Management Strategy Index		0, 6, 9 months
Secondary	Perceived Change Scale		0, 6, 9 months