Clinical trial NCT01640470: A Multi-Site Trial of the Impact of Assistive Technology With Assistance Users and Their Caregivers
Official title: A Multi-Site Trial of the Impact of Assistive Technology With Individuals With Mobility Limitations and Their Caregivers.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Mobility Disability
Older Adults
Community Dwelling
Keywords: assistive technology
environmental modification
caregiver
client-centred
Lead sponsor: Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Sponsor class: OTHER
Collaborators: name: Simon Fraser University
name: Duke University
name: University of Ottawa
First posted: 2012-07-13
Enrollment: 240
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Caregiver Assistive Technology Outcome Measure
timeFrame: 58 Weeks
measure: Functional Autonomy Measure (Système de mesure de l'autonomie fonctionnelle (SMAF))
timeFrame: 58 weeks
Secondary outcomes:
measure: Sub-scale scores from the Functional Autonomy Measure (Système de mesure de l'autonomie fonctionnelle (SMAF))
timeFrame: baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3)
measure: Sub-scale scores from the Caregiver Assistive Technology Outcome Measure
timeFrame: baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3).
measure: Euro-QOL 5
timeFrame: baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3).
measure: Caregiver Burden Inventory
timeFrame: baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3).
measure: Reintegration to Normal Living Index (RNLI)
timeFrame: baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3).
measure: Self-report of Functional Independence
timeFrame: baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3).
measure: Qualitative interviews
timeFrame: week 6 and week 58
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Simon Fraser University- Gerontolgy Research Centre
state: British Columbia
city: Ottawa
country: Canada
facility: Élisabeth Bruyère Research Centre
state: Ontario
city: Montreal
country: Canada
facility: University of Montreal
state: Quebec
Study officials:
affiliation: Université de Montréal
name: Louise Demers, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.