ClinicalTrials.Veeva

Menu

Supporting Caregivers of Persons With Dementia: A Pilot Study

McMaster University logo

McMaster University

Status and phase

Completed
Phase 3
Phase 2

Conditions

Alzheimer Disease
Dementia

Treatments

Behavioral: Environmental Skill Building
Behavioral: Education Control

Study type

Interventional

Funder types

Other

Identifiers

NCT00908492
ASC1050

Details and patient eligibility

About

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.

Enrollment

38 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

38 participants in 2 patient groups

Education Control
Active Comparator group
Treatment:
Behavioral: Education Control
Environmental Skill Building
Experimental group
Treatment:
Behavioral: Environmental Skill Building

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems