A Phase 2 interventional study of Assistive Technology Provision and Tune-Up Intervention and Customary Care in Mobility Disability, Older Adults and Community Dwelling, sponsored by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal. Status unknown at 3 sites in Canada. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2016-04-11.
Sponsored by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal · Phase 2, Interventional, and Treatment
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:
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.
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal is the lead sponsor of 18 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Participants in this arm will receive customary care.
Device: Customary Care
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.
Participants in the customary care group receive normal occupational therapy services.Occupational Therapy
Also known as: Customary device prescription and training
Caregiver Assistive Technology Outcome Measure
The caregiver assistive technology outcome measure captures physical and psychological associated with informal care provision.
Time frame: 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)
Time frame: 58 weeks
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.
Time frame: 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.
Time frame: 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,
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: week 6 and week 58
This study is status unknown, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal