Self-efficacy Clinical Trial
Official title:
Wheelchair Self-efficacy Enhanced Training Program to Improve Wheelchair Use in Older Adults
Self-efficacy predicts behavioural and rehabilitation outcomes and may be an important psychological factor for wheelchair mobility. A feasibility study will evaluate a novel self-efficacy enhanced wheelchair training intervention for older adults (WheelSeeU) to determine if: 1.WheelSeeU is feasible to administer; 2. WheelSeeU improves wheelchair use, confidence for wheelchair use, wheelchair mobility, and satisfaction with participation in older adults compared to group-based information sessions; and 3. the study design is appropriate. This feasibility study will allow for study design and protocol refinement and will provide pilot data for an experimental trial.
This study will use a two-site (Vancouver and Quebec City), single blinded (Tester) RCT to
compare differences in older adults' wheelchair skill with WheelSeeU versus group-based
information sessions. Subjects will be randomly assigned to the experimental group
(WheelSeeU) or a control group (information sessions) using a 1:1 allocation ratio between
groups. To support balance between groups and blinding of assignment, a central computerized
randomization process will be designed by our team statistician, with an undisclosed block
size and stratified by site (Vancouver n = 20 [+4 for 20% dropout]; Quebec City n = 20 +4 ).
Once subjects are enrolled, the Tester will collect baseline data and enter them into a
secure database. The Site Coordinator will contact Dr. Goldsmith via telephone or email and
obtain group assignment within 48 hours. Subject contact information will be forwarded to the
appropriate group Trainer to arrange for an initial training session or peer support session.
To address bias, subjects will be instructed not to discuss their program and the Testers (1
per site) will be blinded to group allocation. Follow-up testing will occur at immediately
and 6 months post-intervention.
To mask the participants from the study objectives, participants in both the intervention and
control groups will be told that the intervention is designed to improve wheelchair use. The
findings from the study will be summarized and mailed to each participant upon study
completion.
WheelSeeU and the control group will be held at Blusson Spinal Cord Centre, GF Strong or in
the community depending on participant preference.
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