WheelSeeU Feasibility Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2016-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Self-efficacy Wheelchair Mobility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group-based information sessions

Control group subjects will take part in 6 x 1.5 hour sessions of group-based information sessions facilitated by a trained instructor, consisting of topics on general wheelchair use, transportation, pain and fatigue management, nutrition, and internet resources. The instructor will be trained to not provide any training on wheelchair skills, and will be instructed to divert any wheelchair skills related questions.

Group Type NO_INTERVENTION

No interventions assigned to this group

WheelSeeU Training Program

Experimental group subjects will attend 6 x 1.5 hour training sessions (1-2 sessions/week) with a peer-Trainer. The peer-Trainer will facilitate WheelSeeU sessions and will lead participants through practice of wheelchair use goals.

Group Type EXPERIMENTAL

WheelSeeU Training Program

Intervention Type DEVICE

WheelSeeU sessions will be administered by a peer-trainer (older adult wheelchair user), who will be trained in a 2-day workshop to use social cognitive approaches (i.e. facilitating successful performance of wheelchair skills, learning through observation of peers, positive verbal reinforcement from peers and family members, and re-interpretation of physiological symptoms) to foster the improvement of self-efficacy for wheelchair use. Each WheelSeeU session will be tailored to the individual goals of participants, which will be identified during the start of each session.

Interventions

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WheelSeeU Training Program

WheelSeeU sessions will be administered by a peer-trainer (older adult wheelchair user), who will be trained in a 2-day workshop to use social cognitive approaches (i.e. facilitating successful performance of wheelchair skills, learning through observation of peers, positive verbal reinforcement from peers and family members, and re-interpretation of physiological symptoms) to foster the improvement of self-efficacy for wheelchair use. Each WheelSeeU session will be tailored to the individual goals of participants, which will be identified during the start of each session.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No