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Completed

NCT Number: NCT00908492

Supporting Caregivers of Persons With Dementia: A Pilot Study

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

McMaster University

Hamilton, Ontario, L8S 1C7, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Education Control

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Revised Memory and Behavior Problem Checklist

    Time frame: 0, 6, 9 months

Secondary outcomes

  1. Disability Assessment for Dementia

    Time frame: 0, 6, 9 months

  2. Number of caregiving assistance hours

    Time frame: 0, 6, 9 months

  3. Short Zarit Burden Interview

    Time frame: 0, 6, 9 months

  4. Task Management Strategy Index

    Time frame: 0, 6, 9 months

  5. Perceived Change Scale

    Time frame: 0, 6, 9 months

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Alzheimer Society of Canada

Registry information

Official study title

Pilot Study of the Environmental Skill Building Program for Dementia Caregivers

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
May 27, 2009
Registry last updated
Apr 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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