CaregiversNCT03856749
Effectiveness of Wheelchair Skills Training for Caregivers of Manual Wheelchair Users
A study testing Remote wheelchair skills training in people with Caregivers, run by Lee Kirby at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregivers
- What is being tested?
- Remote wheelchair skills training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteCanada
- Study dates
- 4 Dec 2019to 30 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
- 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
- -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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Caregivers
- Being tested
- Remote wheelchair skills training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote wheelchair skills trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | The wheelchair user and caregiver will be trained together on wheelchair skills using remote technology (Zoom for healthcare and/or Facetime). Receives: Other: Remote wheelchair skills training |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 18 weeks
Secondary outcomes (4)
Satisfaction with wheelchair skills training over course of study
Participants will be asked their perceptions of the content and benefits of the training material.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start4 Dec 2019
- Primary completion30 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CaregiversStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-blind randomized controlled trial. Each participant in the study consists of a caregiver and wheelchair user dyad. 1 dyad = 1 manual wheelchair user + his/her caregiver.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lee Kirby
- Sponsor type
- University, hospital or other
- Collaborators
- IWK Health Centre
- Responsible party
- Sponsor-investigator, Lee Kirby, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856749
- Sponsor's protocol ID
- WSP2019-01
- Status last verified
- Feb 2024
- First submitted
- 22 Feb 2019
- Last updated
- 6 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kirby RL, Smith C, Miller MD, Osmond D, Sherman MA, Parker K, Koto PS, Theriault CJ, Sandila N. Wheelchair skills training for caregivers of manual wheelchair users: a randomized controlled trial comparing self-study and remote training. Disabil Rehabil Assist Technol. 2024 Nov;19(8):2896-2903. doi: 10.1080/17483107.2024.2321272. Epub 2024 Feb 29.
PubMed 38420947
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Wheelchair Skills Training for Caregivers of Manual Wheelchair Users: a Randomized Waitlist-controlled Trial
- ClinicalTrials.gov ID
- NCT03856749
- Acronym / sponsor ID
- WSP2019-01
- Conditions
- Caregivers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Lee KirbyUniversity, hospital or other
- Collaborators
- IWK Health Centre
- Study start
- 4 Dec 2019 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 27 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A single-blind randomized controlled trial. Each participant in the study consists of a caregiver and wheelchair user dyad. 1 dyad = 1 manual wheelchair user + his/her caregiver.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: Remote wheelchair skills trainingThe wheelchair user and caregiver will be trained together on wheelchair skills using remote technology (Zoom for healthcare and/or Facetime). |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
- a person who uses a manual wheelchair
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote wheelchair skills trainingPrior 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. | Other | Treatment |
Primary outcome
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).
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).
4 secondary outcomes
Satisfaction with wheelchair skills training over course of study
Time frame: 5 weeks, 18 weeks
Cost-effectiveness of training
Time frame: 5 weeks
Change from baseline in quality of life at 5 weeks
Time frame: 5 weeks
Change from baseline in quality of life at 18 weeks
Time frame: 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Derived from this study: PubMed 38420947Kirby RL, Smith C, Miller MD, Osmond D, Sherman MA, Parker K, Koto PS, Theriault CJ, Sandila N. Wheelchair skills training for caregivers of manual wheelchair users: a randomized controlled trial comparing self-study and remote training. Disabil Rehabil Assist Technol. 2024 Nov;19(8):2896-2903. doi: 10.1080/17483107.2024.2321272. Epub 2024 Feb 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote wheelchair skills training in people with Caregivers, run by Lee Kirby at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Wheelchair Skills Test Questionnaire at 5 weeks (time frame: 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03856749, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.