Overview

This trial is active, not recruiting.

Conditions mobility disability, older adults, community dwelling
Treatments assistive technology provision and tune-up intervention, customary care
Phase phase 2
Sponsor Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Collaborator Simon Fraser University
Start date December 2011
End date May 2016
Trial size 240 participants
Trial identifier NCT01640470, 232262

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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.
assistive technology provision and tune-up intervention
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)
Participants in this arm will receive customary care.
customary care Customary device prescription and training
Participants in the customary care group receive normal occupational therapy services.Occupational Therapy

Primary Outcomes

Measure
Caregiver Assistive Technology Outcome Measure
time frame: 58 Weeks
Functional Autonomy Measure (Système de mesure de l'autonomie fonctionnelle (SMAF))
time frame: 58 weeks

Secondary Outcomes

Measure
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)
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).
Euro-QOL 5
time frame: 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).
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).
Self-report of Functional Independence
time frame: 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

Eligibility Criteria

Male or female participants at least 55 years old.

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.

Additional Information

Official title A Multi-Site Trial of the Impact of Assistive Technology With Individuals With Mobility Limitations and Their Caregivers.
Principal investigator Louise Demers, PhD
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal.