Effectiveness of Wheelchair Skills Training for Caregivers of Manual Wheelchair Users

Caregivers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03856749
• Other study ID #: WSP2019-01
• Status: Completed
• Phase: N/A
• Start date: December 4, 2019
• Est. completion date: May 30, 2023

Study information

• Verified date: February 2024
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: May 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Caregivers

Intervention

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.

Locations

Country	Name	City	State
Canada	Nova Scotia Rehabilitation Centre	Halifax	Nova Scotia

Sponsors (2)

Lead Sponsor	Collaborator
Lee Kirby	IWK Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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