Effectiveness of Wheelchair Skills Training for Caregivers of Manual Wheelchair Users

Effectiveness of Wheelchair Skills Training for Caregivers of Manual Wheelchair Users: a Randomized Waitlist-controlled Trial

Although there have been a small number of studies suggesting the important role that caregivers play in assisting wheelchair users with mobility, there has never been a randomized controlled trial (RCT) looking at the effectiveness or cost-utility of wheelchair skills training for caregivers. The overall goal of this study is to correct this knowledge gap and, triggered by the COVID-19 pandemic of 2020, to conduct the training remotely. The main purpose of this study is to test if providing wheelchair skills training remotely to caregivers of manual wheelchair users enhances caregiver-assisted wheelchair skills ability and confidence in comparison to a control group of participants who are receiving usual care and self-study material on wheelchair skills. The investigators will also study whether the benefits of training are still seen at a 6-week follow-up and assess the health-economic impact of caregiver training.

Study Overview

• Status: Completed
• Conditions: Caregivers
• Intervention / Treatment: Other: Remote wheelchair skills training

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 4K4
      • Nova Scotia Rehabilitation Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria for caregiver and wheelchair user dyad

• be ≥ 18 years of age
• able to communicate in English
• be willing to participate and be committed to setting regularly scheduled times for the study activities
• will need to have the appropriate connectivity for the remote training and testing (i.e. telephone, limited-access e-mail and internet).

Exclusion Criteria for caregiver and wheelchair user dyad :

• fail to complete the baseline (T1) assessment
• have unstable medical conditions (e.g. angina, seizures) that might make the use of a manual wheelchair dangerous
• emotional problems (e.g. severe anxiety, depression) that might make participation unsafe or unpleasant
• have a medical condition that is likely to deteriorate in the three months following enrollment.

Inclusion Criteria for wheelchair user

• a person who uses a manual wheelchair
• be expected to continue to use a manual wheelchair at least part-time in the coming months
• requires no more than minimal assistance for communication and auditory comprehension

Inclusion Criteria for caregiver of wheelchair user

-must be a caregiver (e.g. a family member, friend, volunteer or regular homecare worker) who spends an average total of at least 2 hours per week with the manual wheelchair user that includes manual wheelchair mobility.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; The wheelchair user and caregiver will be trained together on wheelchair skills using remote technology (Zoom for healthcare and/or Facetime).	Other: Remote wheelchair skills training; Prior to the first training session, the trainer will be provided with the results from the assessment immediately preceding training to provide him/her time to individualize the training session. Trainer will provide self-study materials (the Caregiver Handbook and caregiver-training video-recording) and an explanation on how these materials should be used. The wheelchair user and caregiver will be trained together on wheelchair skills, using the principles of the Wheelchair Skills Training Program, as outlined in the Wheelchair Skills Program Manual using remote technology. Each training session will be with a trainer-to-dyad ratio of 1:1 1 dyad = 1 manual wheelchair user + his/her caregiver. Training will continue until the goals have been met and retained (for at least one subsequent session), using up to 4 training sessions that will each last up to 60 minutes at intervals a minimum of 3 days.
No Intervention: Control; The wheelchair user and caregiver will receive the same self-study materials provided to the Treatment arm. Usual care, which may include wheelchair skills training for both wheelchair users and caregivers( but which often does not do so to an adequate extent) by wheelchair user's clinical therapist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Wheelchair Skills Test Questionnaire at 5 weeks	Change from baseline in self-reported ability and confidence to perform 33 wheelchair skills. Score ranges from 0-100%, with 0 indicating a poor outcome (not able to do any wheelchair skills and 100% indicating being able to do all the skills).	5 weeks
Change from baseline in Wheelchair Skills Test Questionnaire at 18 weeks	Change from baseline in self-reported ability and confidence to perform 33 wheelchair skills. Score ranges from 0-100%, with 0 indicating a poor outcome (not able to do any wheelchair skills and 100% indicating being able to do all the skills).	18 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with wheelchair skills training over course of study	Participants will be asked their perceptions of the content and benefits of the training material.	5 weeks, 18 weeks
Cost-effectiveness of training	Measured using Quality-Adjusted Life Years (QALY), estimated costs and quality of life. QALY scores range from 0(dead) to 1(perfect health).	5 weeks
Change from baseline in quality of life at 5 weeks	Change from baseline in quality of life measured using the EQ-5D-5L as validated quality of life self-report outcome measure. Scores range from 1 (no problem) to 5 (extreme problem) in dimensions of mobility, self-care, activities, pain and mental health. General health score from 0 % (worst health imaginable) to 100% (best health imaginable).	5 weeks
Change from baseline in quality of life at 18 weeks	Change from baseline in quality of life measured using the EQ-5D-5L as validated quality of life self-report outcome measure. Scores range from 1 (no problem) to 5 (extreme problem) in dimensions of mobility, self-care, activities, pain and mental health. General health score from 0 % (worst health imaginable) to 100% (best health imaginable).	18 weeks

Collaborators and Investigators

• Sponsor: Lee Kirby
• Collaborators: IWK Health Centre

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2019
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): May 30, 2023

Study Registration Dates

• First Submitted: February 22, 2019
• First Submitted That Met QC Criteria: February 26, 2019
• First Posted (Actual): February 27, 2019

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: WSP2019-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No