- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01640470
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:
- To determine the efficacy of the Assistive Technology Provision, Updating and Training intervention for assistance users and for their caregivers.
- 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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
British Columbia
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Vancouver, British Columbia, Canada, V6B 5K3
- Simon Fraser University- Gerontolgy Research Centre
-
-
Ontario
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Ottawa, Ontario, Canada, K1N 5C8
- Élisabeth Bruyère Research Centre
-
-
Quebec
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Montreal, Quebec, Canada, H3W 1W5
- University of Montreal
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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.
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58 Weeks
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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.
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baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3)
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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).
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For caregivers, sub-scale scores of frequency of physical and psychological burden from the CATOM will be used.
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baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3).
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Euro-QOL 5
Time Frame: baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3).
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For caregivers, health-related quality of life.
Health related quality of life will be measured using the EuroQol,
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baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3).
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Caregiver Burden Inventory
Time Frame: baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3).
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A composite score from the first three subscales of the Caregiver Burden Inventory will be used as a secondary outcome measure for caregivers.
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baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3).
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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).
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The RNLI will measure problems with social participation among assistance users.
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baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3).
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Self-report of Functional Independence
Time Frame: baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3).
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Assistance users and caregivers will independently evaluate perceived functional Independence of assistance users.
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baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3).
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Qualitative interviews
Time Frame: week 6 and week 58
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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.
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week 6 and week 58
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Collaborators and Investigators
Investigators
- Principal Investigator: Louise Demers, PhD, Université de Montréal
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 232262
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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