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

NCT01640470 | Unknown Phase 2 DMC

• 1 other identifier: 232262
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 3

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

Conditions

Mobility Disability; Older Adults; Community Dwelling

Keywords

assistive technology; environmental modification; caregiver; client-centred

Outcome Measures

Primary Outcomes (2)

• Caregiver Assistive Technology Outcome Measure

  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))

  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 Outcomes (7)

• Sub-scale scores from the Functional Autonomy Measure (Système de mesure de l'autonomie fonctionnelle (SMAF))

  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

  baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3).

• Euro-QOL 5

  baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3).

• Caregiver Burden Inventory

  baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3).

• Reintegration to Normal Living Index (RNLI)

  baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3).

Study Arms (2)

Assistive technology

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.

Device: Assistive Technology Provision and Tune-Up Intervention

Customary care

ACTIVE COMPARATOR

Participants in this arm will receive customary care.

Device: Customary Care

Interventions

Assistive Technology Provision and Tune-Up Intervention DEVICE

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.

Assistive technology

Customary Care DEVICE

Participants in the customary care group receive normal occupational therapy services.Occupational Therapy

Also known as: Customary device prescription and training

Customary care

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal: lead
• Simon Fraser University: collaborator
• Duke University: collaborator
• University of Ottawa: collaborator

Study Sites (3)

Simon Fraser University- Gerontolgy Research Centre

Vancouver, British Columbia, V6B 5K3, Canada

Location

Élisabeth Bruyère Research Centre

Ottawa, Ontario, K1N 5C8, Canada

Location

University of Montreal

Montreal, Quebec, H3W 1W5, Canada

Location

Related Publications (2)

• Ben Mortenson W, Demers L, Fuhrer MJ, Jutai JW, Bilkey J, Plante M, DeRuyter F. Effects of a caregiver-inclusive assistive technology intervention: a randomized controlled trial. BMC Geriatr. 2018 Apr 18;18(1):97. doi: 10.1186/s12877-018-0783-6.

  PMID: 29669536 DERIVED

• Demers L, Mortenson WB, Fuhrer MJ, Jutai JW, Plante M, Mah J, DeRuyter F. Effect of a tailored assistive technology intervention on older adults and their family caregiver: a pragmatic study protocol. BMC Geriatr. 2016 May 13;16:103. doi: 10.1186/s12877-016-0269-3.

  PMID: 27177609 DERIVED

Study Officials

• Louise Demers, PhD

  Université de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Directrice, Département de l'ergothérapie

Study Record Dates

• First Submitted: November 21, 2011
• First Posted: July 13, 2012
• Study Start: December 1, 2011
• Primary Completion: May 1, 2016
• Study Completion: March 1, 2017
• Last Updated: April 11, 2016

Record last verified: 2016-04

Locations

CA (3)