Clinical trial NCT03856749: Effectiveness of Wheelchair Skills Training for Caregivers of Manual Wheelchair Users
Official title: Effectiveness of Wheelchair Skills Training for Caregivers of Manual Wheelchair Users: a Randomized Waitlist-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregivers
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: IWK Health Centre
First posted: 2019-02-27
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in Wheelchair Skills Test Questionnaire at 5 weeks
timeFrame: 5 weeks
measure: Change from baseline in Wheelchair Skills Test Questionnaire at 18 weeks
timeFrame: 18 weeks
Secondary outcomes:
measure: Satisfaction with wheelchair skills training over course of study
timeFrame: 5 weeks, 18 weeks
measure: Cost-effectiveness of training
timeFrame: 5 weeks
measure: Change from baseline in quality of life at 5 weeks
timeFrame: 5 weeks
measure: Change from baseline in quality of life at 18 weeks
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Rehabilitation Centre
state: Nova Scotia
Study officials:
References: