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Completed

NCT Number: NCT03856749

Effectiveness of Wheelchair Skills Training for Caregivers of Manual Wheelchair Users

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nova Scotia Rehabilitation Centre

Halifax, Nova Scotia, B3H 4K4, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remote wheelchair skills training

Other

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.

Primary outcomes

  1. Change from baseline in Wheelchair Skills Test Questionnaire at 5 weeks

    Time frame: 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).

  2. Change from baseline in Wheelchair Skills Test Questionnaire at 18 weeks

    Time frame: 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).

Secondary outcomes

  1. Satisfaction with wheelchair skills training over course of study

    Time frame: 5 weeks, 18 weeks

    Participants will be asked their perceptions of the content and benefits of the training material.

  2. Cost-effectiveness of training

    Time frame: 5 weeks

    Measured using Quality-Adjusted Life Years (QALY), estimated costs and quality of life. QALY scores range from 0(dead) to 1(perfect health).

  3. Change from baseline in quality of life at 5 weeks

    Time frame: 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).

  4. Change from baseline in quality of life at 18 weeks

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Lee Kirby

Other

Collaborators

  • IWK Health Centre

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Feb 27, 2019
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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