Clinical trial NCT04953364: Self-Management for Amputee Rehabilitation Using Technology.
Official title: Self-management for Amputee Rehabilitation Using Technology (SMART) Program: a Peer Supported mHealth Approach for Rehabilitation After Lower Limb Amputation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Behavior
Amputation
Lower Limb Amputation Above Knee (Injury)
Lower Limb Amputation Below Knee (Injury)
Lower Limb Amputation Knee
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2021-07-08
Enrollment: 82
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial (RCT)
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: Importance: Amputation is a stressful experience which causes daily fluctuations in psychological and physical functioning and social interactions. Yearly, more than 7300 patients are admitted to hospitals nationwide for lower limb amputation (LLA), with the majority (86%) occurring in adults over 50. Consequences of LLA, such as a change in body image, mobility restrictions, and pain, may lead to depression, social isolation and decreased quality of life. Clients may lack coping strategies, educational resources, or access to rehabilitation services, especially for rural living Canadians. Online eHealth approaches, including the use of tablets, are considered effective approaches for delivering self-management programs, while addressing logistical barriers. Using a participatory action research approach, an eHealth platform for individuals with LLA called Self-Management for Amputee Rehabilitation using Technology (SMART) was co-designed and co-developed.

The investigators' goal is to determine the effectiveness and retention effect of SMART in community dwelling older adults (≥50yrs) with unilateral LLA, while documenting implementation factors. the hypothesis driving this investigation is that older adults with LLA who receive SMART intervention, compared with paper-based education as a control group, will have greater positive changes in confidence in their ambulation and walking capacity.

Methods: Using a Type 1 Effectiveness-Implementation Hybrid Design randomized controlled trial (RCT), the 6-week effectiveness and 4-week retention effect of SMART will be assessed on patient-relevant outcomes, and implementation. A volunteer sample of men and women, aged ≥50 years, with unilateral transtibial or transfemoral LLA, who started casting of their initial prosthetic limb, with command of English will be recruited from BC and ON. The sample will be randomly allocated to the experimental (SMART) (n=41) or control group (n=41), with a ratio of 1:1. Both groups will receive usual care, provided by their healthcare providers. The experimental group will receive a SMART enabled tablet for daily use (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. The tablet will also allow asynchronous contact with trainers through a secure website. The control group will receive a care booklet and weekly contacts. All data collection will be conducted using Zoom online platform, hosted by University of British Columbia. Confidence in ambulation will be measured by Ambulatory Self-Confidence Questionnaire (ASCQ) and Walking capacity will be assessed using the Timed Up and Go test (TUG)--these measures will be conducted under remote supervision via Zoom. Five elements of implementation will be assessed including, reach (target population), effectiveness (effects of SMART), adoption (by setting/staff), implementation (dose delivered and fidelity), and maintenance of the behavior (in target population and settings). Online one-on-one semi-structured interviews with 20 participants (SMART group) will be used to assess the participants' experience. The interviews will be conducted using Zoom video calls. Analyses: Outcomes will be disaggregated for sex and gender differences. Between- and within- group differences will be assessed by covariance analysis. Thematic analyses of qualitative data will explore participants' experience.

Noah Tregobov's role will be that of the research assistant. Elham Esfandiari will be coordinating most of the research as a graduate student.

William Miller is the PI and will oversee the overall execution of the project. All other team members will serve as resources for information, recruitment, research design, etc. but will not directly interact with participants.

Eligibility criteria: Inclusion Criteria:

* Has a unilateral LLA (transtibial or transfemoral) due to diabetes or vascular disease
* Received initial casting of their prosthesis within the past 2 years
* Be aged ≥ 50 years (85% of adults with LLA)
* Self-identifies as being able to speak and read English.
* Has access to computer or tablet and internet.
* Individuals living in British Columbia or Ontario, Canada.

Exclusion Criteria:

* Substantial health conditions (e.g., congestive heart failure, diagnosed dementia)
* Those anticipating further surgery (e.g. LLA revision) as identified by our study sites' physiatrists
* an inability to use a tablet (e.g. using hands for typing).

Primary outcomes:
measure: TUG, Timed Up and Go test
timeFrame: Ten weeks
measure: ASCQ, the Ambulatory Self-Confidence Questionnaire
timeFrame: Ten weeks
Secondary outcomes:
measure: Self-Report Habit Index (SRHI)
timeFrame: Ten weeks
measure: Physical Activity Identity (PAI)
timeFrame: Ten weeks
measure: The Revised Amputee Body Image Scale (ABIS-R)
timeFrame: Ten weeks
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: Ten weeks
measure: Self-Report Habit Index (SRH)
timeFrame: Ten weeks
measure: Activities Specific Balance Confidence (ABC) Scale
timeFrame: Ten weeks
measure: Residual limb pain, phantom pain, and non-painful phantom limb sensations
timeFrame: Ten weeks
measure: Short Musculoskeletal Function Assessment (SMFA)
timeFrame: Ten weeks
measure: Euro Quality of Life
timeFrame: Ten weeks
measure: Tenacious goal pursuit (TGP)
timeFrame: Ten weeks
measure: Action Planning Scale (AP)
timeFrame: Ten weeks
measure: Self-Management Assessment Scale (SMASc)
timeFrame: Ten weeks
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: GF Strong Rehabilitation Centre
state: British Columbia
Study officials:
affiliation: The University of British Columbia
name: William C Miller, PhD
role: PRINCIPAL_INVESTIGATOR
References: