Older Adults Clinical Trial
— CATSOfficial title:
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:
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.
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal | Duke University, Simon Fraser University, University of Ottawa |
Canada,
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 |
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