A Multi-Site Trial of the Impact of Assistive Technology With Assistance Users and Their Caregivers (CATS)

A Multi-Site Trial of the Impact of Assistive Technology With Individuals With Mobility Limitations and Their Caregivers.

Many individuals with mobility limitations, especially those who are older and have more severe impairments, use a combination of assistive devices and personal assistance to meet their needs. Assistive technology (AT), which includes devices such as wheelchairs, walkers, bathroom grab bars, and dressing aids, helps facilitate day-to-day activities and social participation (basic and instrumental activities of daily living) among these individuals and may decrease their dependence on human assistance. Although some research has reported beneficial outcomes of AT use, few studies have used controlled experimental designs. Furthermore, the results are often difficult to interpret because the AT interventions are only vaguely described. Another concern is that many individuals receive help from others, but scant attention has been paid to the impact of AT on caregivers. This neglect produces an incomplete portrayal of the effect of AT interventions. The proposed study addresses these deficiencies by evaluating the effects of a formalized dyadic AT intervention on individuals with mobility limitations and on their caregivers. The Assistive Technology Provision, Updating and Training (ATPUT)intervention involves a detailed in-home assessment of participants' current AT; the negotiation and implementation of a personal AT plan with the participants and their caregivers; and the provision of AT devices, non-structural home modifications, and device training.

Objectives:

  1. To determine the efficacy of the Assistive Technology Provision, Updating and Training intervention for assistance users and for their caregivers.
  2. To explore how the intervention is experienced by these individuals and to help explain the study findings.

General Hypotheses:

The investigators anticipate this intervention will increase the daily activities and social participation of individuals with mobility limitations; decrease the psychological and physical demands on caregivers; and reduce the amount of caregiving required.

Methodologies:

This research will use a combination of quantitative and qualitative methods. The quantitative portion will be an experimental, single-blinded study in which the investigators randomly assign participants to either the ATPUT or a customary care group.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • British Columbia
      • Vancouver, British Columbia, Canada, V6B 5K3
        • Simon Fraser University- Gerontolgy Research Centre
    • Ontario
      • Ottawa, Ontario, Canada, K1N 5C8
        • Élisabeth Bruyère Research Centre
    • Quebec
      • Montreal, Quebec, Canada, H3W 1W5
        • University of Montreal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • daily activity and/or mobility disability
  • referred to homecare
  • have an unpaid informal caregiver who is above the age of consent and willing to participate in the study
  • can communicate in English or French.

Exclusion Criteria:

  • cognitive impairments that are likely to prevent them from reliably completing the study questionnaires.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Assistive technology
The home based AT Provision, Updating and Tune-Up (ATPUT) Intervention will include recommendations for assistive technology, possibly entailing financial assistance to repair or to acquire new AT, and training. New equipment will likely include devices such as bathroom grab bars, raised toilet seats, walkers, and bath chairs.

The home based AT Provision, Updating and Tune-Up (ATPUT) Intervention will consist of 5 components: 1) identification and prioritization of problematic activities by the assistance user and his/her principal, cohabitating caregiver; 2) in-residence assessment of the daily activities and social participation and preferences of the assistance user; 3) detailed review of the AT and human assistance that are currently being used; 4) recommendations by an occupational therapist for possible changes in the personal assistance strategy; 5) negotiation of an ATPUT Personal Plan with the assistance user and her/his principal caregiver.

The intervention occurs over a six week period and involves 3 to 6 visits from an occupational therapist.

Active Comparator: Customary care
Participants in this arm will receive customary care.
Participants in the customary care group receive normal occupational therapy services.Occupational Therapy
Other Names:
  • Customary device prescription and training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caregiver Assistive Technology Outcome Measure
Time Frame: 58 Weeks
The caregiver assistive technology outcome measure captures physical and psychological associated with informal care provision.
58 Weeks
Functional Autonomy Measure (Système de mesure de l'autonomie fonctionnelle (SMAF))
Time Frame: 58 weeks
A composite from two sub-scales of the SMAF will be used the primary outcome measure for users (self-care and mobility)
58 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sub-scale scores from the Functional Autonomy Measure (Système de mesure de l'autonomie fonctionnelle (SMAF))
Time Frame: baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3)
Three sub-scales from the Functional Autonomy Measure (Système de mesure de l'autonomie fonctionnelle (SMAF)) (self-care, mobility and instrumental) will be used as secondary outcome measures for assistance users.
baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3)
Sub-scale scores from the Caregiver Assistive Technology Outcome Measure
Time Frame: baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3).
For caregivers, sub-scale scores of frequency of physical and psychological burden from the CATOM will be used.
baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3).
Euro-QOL 5
Time Frame: baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3).
For caregivers, health-related quality of life. Health related quality of life will be measured using the EuroQol,
baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3).
Caregiver Burden Inventory
Time Frame: baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3).
A composite score from the first three subscales of the Caregiver Burden Inventory will be used as a secondary outcome measure for caregivers.
baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3).
Reintegration to Normal Living Index (RNLI)
Time Frame: baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3).
The RNLI will measure problems with social participation among assistance users.
baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3).
Self-report of Functional Independence
Time Frame: baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3).
Assistance users and caregivers will independently evaluate perceived functional Independence of assistance users.
baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3).
Qualitative interviews
Time Frame: week 6 and week 58
A purposive sample of participants will be interviewed immediately after the intervention and at the end of the study to understand better how the intervention was administered by therapists and experienced by assistance users and their caregivers.
week 6 and week 58

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Louise Demers, PhD, Université de Montréal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Anticipated)

May 1, 2016

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

November 21, 2011

First Submitted That Met QC Criteria

July 10, 2012

First Posted (Estimate)

July 13, 2012

Study Record Updates

Last Update Posted (Estimate)

April 11, 2016

Last Update Submitted That Met QC Criteria

April 8, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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