Clinical trial NCT01838135: WheelSeeU Feasibility Study
Official title: Wheelchair Self-efficacy Enhanced Training Program to Improve Wheelchair Use in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self-efficacy
Wheelchair Mobility
Keywords: wheelchair
manual wheelchair
rehabilitation
self-efficacy
older adults
feasibility
intervention
training
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2013-04-23
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 55 years of age or older
* live in the community
* self-propel a manual wheelchair at least 1 hour/day
* have wheelchair mobility goals
* are cognitively able to engage in the program (Modified Mini-mental Status Exam score of ≥ 24).

Exclusion Criteria:

* cannot communicate and complete study questionnaires in English
* anticipate a health condition or procedure that contraindicates training (e.g., surgery scheduled which would impair physical activity)
* have a degenerative condition that is expected to progress quickly (e.g., Amyotrophic lateral sclerosis (ALS))
* are concurrently or are planning to receive wheelchair mobility training during the period of the study.

Primary outcomes:
measure: Wheelchair Skills Test Version 4.1 (WST) Change
timeFrame: Baseline, 6 weeks, 6 month follow-up
Secondary outcomes:
measure: Wheelchair-use Confidence Scale (WheelCon) Version 3.0
timeFrame: Baseline, 6 weeks, 6 month follow-up
measure: Wheelchair Skills Test Version 4.1 Questionnaire (WST-Q)
timeFrame: Baseline, 6 weeks, 6 month follow-up
measure: Life-Space Assessment (LSA)
timeFrame: Baseline, 6 weeks, 6 month follow-up
measure: Wheelchair Outcome Measure (WhOM)
timeFrame: Baseline, 6 weeks, 6 month follow-up
measure: Late Life Function and Disability Instrument (LLFDI)
timeFrame: Baseline, 6 weeks, 6 month follow-up
measure: Health Utility Index Mark 3 (HUI3)
timeFrame: Baseline, 6 weeks, 6 month follow-up
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: GF Strong Rehabilitation Centre
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: William C Miller, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miller WC, Best KL, Eng JJ, Routhier F. Influence of Peer-led Wheelchair Training on Wheelchair Skills and Participation in Older Adults: Clinical Outcomes of a Randomized Controlled Feasibility Trial. Arch Phys Med Rehabil. 2019 Jun;100(6):1023-1031. doi: 10.1016/j.apmr.2018.10.018. Epub 2018 Nov 23.
citation: Best KL, Miller WC, Routhier F, Eng JJ. Feasibility of the trial procedures for a randomized controlled trial of a community-based peer-led wheelchair training program for older adults. Pilot Feasibility Stud. 2017 Jul 17;4:18. doi: 10.1186/s40814-017-0158-3. eCollection 2018.
citation: Best KL, Miller WC, Eng JJ, Routhier F, Goldsmith C. Randomized controlled trial protocol feasibility: The Wheelchair Self-Efficacy Enhanced for Use (WheelSeeU). Can J Occup Ther. 2014 Dec;81(5):308-19. doi: 10.1177/0008417414546743.