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

Study Overview
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Brief Summary
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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.

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

Conditions
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Mobility Disability, Older Adults, Community Dwelling

Intervention / Treatment
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* Device: Assistive Technology Provision and Tune-Up Intervention
* Device: Customary Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Assistive technology<br>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<br>* 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.<br>|
| Active Comparator: Customary care<br>Participants in this arm will receive customary care. | Device: Customary Care<br>* Participants in the customary care group receive normal occupational therapy services.Occupational Therapy<br>* Other names: Customary device prescription and training;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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). | 
| 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). | 
| 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). | 
| 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). | 
| 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). | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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assistive technology, environmental modification, caregiver, client-centred