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

Older Adults Clinical Trial

— CATS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01640470
• Other study ID #: 232262
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 21, 2011
• Last updated: April 8, 2016
• Start date: December 2011
• Est. completion date: March 2017

Study information

• Verified date: April 2016
• Source: Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: March 2017
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Community Dwelling
• Mobility Disability
• Older Adults

Intervention

Device:
• 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.
• Customary Care
Participants in the customary care group receive normal occupational therapy services.Occupational Therapy

Locations

Country	Name	City	State
Canada	University of Montreal	Montreal	Quebec
Canada	Élisabeth Bruyère Research Centre	Ottawa	Ontario
Canada	Simon Fraser University- Gerontolgy Research Centre	Vancouver	British Columbia

Sponsors (4)

Lead Sponsor	Collaborator
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal	Duke University, Simon Fraser University, University of Ottawa

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caregiver Assistive Technology Outcome Measure	The caregiver assistive technology outcome measure captures physical and psychological associated with informal care provision.	58 Weeks	No
Primary	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	No
Secondary	Sub-scale scores from the Functional Autonomy Measure (Système de mesure de l'autonomie fonctionnelle (SMAF))	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)	No
Secondary	Sub-scale scores from the Caregiver Assistive Technology Outcome Measure	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).	Yes
Secondary	Euro-QOL 5	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).	No
Secondary	Caregiver Burden Inventory	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).	No
Secondary	Reintegration to Normal Living Index (RNLI)	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).	No
Secondary	Self-report of Functional Independence	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).	No
Secondary	Qualitative interviews	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	No