NCT00908492

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at below P25 for phase_2 alzheimer-disease

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_2 alzheimer-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 27, 2009

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

April 7, 2015

Status Verified

April 1, 2015

Enrollment Period

1.7 years

First QC Date

May 26, 2009

Last Update Submit

April 6, 2015

Conditions

Alzheimer DiseaseDementia

Keywords

Randomized control trialDementia caregiversOccupational TherapyCaregivers

Outcome Measures

Primary Outcomes (1)

  • Revised Memory and Behavior Problem Checklist

    0, 6, 9 months

Secondary Outcomes (5)

  • 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

Study Arms (2)

Education Control

ACTIVE COMPARATOR
Behavioral: Education Control

Environmental Skill Building

EXPERIMENTAL
Behavioral: Environmental Skill Building

Interventions

Education ControlBEHAVIORAL

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.

Education Control
Environmental Skill BuildingBEHAVIORAL

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.

Environmental Skill Building

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 1C7, Canada

Location

MeSH Terms

Conditions

Alzheimer DiseaseDementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Lori Letts

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 26, 2009

First Posted

May 27, 2009

Study Start

November 1, 2009

Primary Completion

August 1, 2011

Study Completion

September 1, 2011

Last Updated

April 7, 2015

Record last verified: 2015-04

Locations

CA(1)