Self-Management for Amputee Rehabilitation Using Technology.
- Sponsor
- University of British Columbia
- Study ID
- NCT04953364
- Status
- Recruiting
Conditions
- Amputation
- Behavior
- Lower Limb Amputation Above Knee (Injury)
- Lower Limb Amputation Below Knee (Injury)
- Lower Limb Amputation Knee
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- SMART — BEHAVIORALSMART includes mental and physical wellness, residual/prosthetic limb managements, use of a prosthesis and weekly peer-support calls or video call over Zoom, hosted by University of British Columbia, depends on participant's preference, promoting motivation and establishing goal setting and action planning. The tablet will also allow asynchronous contact with trainers through a secure website.
- Control — BEHAVIORALThe control group will receive a care booklet and weekly contacts for 6 weeks.
Study Details
Lower Limb Amputations (LLAs) are a substantial burden on the Canadian health services with nearly 50,000 cases reported between 2006 and 2011. To address the challenging nature of a LLA (e.g., decreased mobility, pain, depression), patients need to go through extensive rehabilitation programs. Effective self-management programs can help those with LLA to monitor their own condition and improve their quality of life. However, a lack of self-management programs, a limited healthcare budget, and a decrease in quality of services (e.g. shorter lengths of stay for inpatients and rapid movement to outpatient services) pose further challenges for patients with LLA. Self-management programs can be provided to clients through online mobile technologies (e.g., tablet) and offer accessible, low-cost, and potentially augmentative rehabilitation after discharge, in both urban and rural areas. To address these needs, an online educational and training platform for individuals with LLA called, Self-Management for Amputee Rehabilitation using Technology (SMART) was designed and developed. SMART focuses on LLA education, prosthetic limb management, and weekly support of peers. It is monitored by a trainer through a website. SMART will be evaluated in men and women with LLA aged 50 years and over, admitted to prosthetic rehabilitation throughout BC and ON. SMART has the potential to influence a client's post-LLA needs with direct (e.g., individual's health) and indirect (e.g., healthcare utilization) benefits. The purpose of this randomized controlled trial is to evaluate the effect of SMART in community dwelling older adults with unilateral, above or below, knee amputation.
Key Dates
- First listed
- Jul 8, 2021
- Start date
- Oct 14, 2022
- Status verified
- Jul 2024
- Primary completion
- Jan 1, 2025
- Completion
- Feb 1, 2026
Study Design
- Enrollment
- 82 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: SMARTThe experimental group will receive access to SMART online platform (6 weeks). SMART includes mental and physical wellness, residual/prosthetic limb managements, use of a prosthesis and weekly peer-support calls or video call over Zoom, hosted by University of British Columbia, depends on participant's preference, promoting motivation and establishing goal setting and action planning. SMART will also allow asynchronous contact with trainers through a secure website.
- Active Comparator: ControlThe control group will receive a care booklet and weekly contacts for 6 weeks.
Primary Outcome Measure
TUG, Timed Up and Go test [ Time Frame: Ten weeks ]
Central Contacts
- William C Miller, PhD+1 (604) 312-5245
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