Self-Management for Amputee Rehabilitation Using Technology.

Amputation Clinical Trial

— SMART  

Official title:

Self-management for Amputee Rehabilitation Using Technology (SMART) Program: a Peer Supported mHealth Approach for Rehabilitation After Lower Limb Amputation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04953364
• Other study ID #: H20-03316
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 15, 2022
• Est. completion date: March 2, 2024

Study information

• Verified date: July 2022
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 82
• Est. completion date: March 2, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Amputation
• Behavior
• Lower Limb Amputation Above Knee (Injury)
• Lower Limb Amputation Below Knee (Injury)
• Lower Limb Amputation Knee
• Wounds and Injuries

Intervention

Behavioral:
• SMART
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.
• Control
The control group will receive a care booklet and weekly contacts for 6 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Canadian Institutes of Health Research (CIHR)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TUG, Timed Up and Go test	The patient stands up upon therapist's command: walks 3 meters, turns around, walks back to the chair and sits down.	Ten weeks
Primary	ASCQ, the Ambulatory Self-Confidence Questionnaire	This questionnaire measures how confident you are in your ability to walk.; Type of Administration: Self-Report.; Response Scale: 0 (not confident at all) - 10 (extremely confident); Scoring: Participants' total score is derived by calculating a mean score; Interpretation: Higher scores = higher level of self-confidence regarding ambulation	Ten weeks
Secondary	Self-Report Habit Index (SRHI)	12-item questionnaire based on the 7-point Likert scale with the range of total score between 0 to 84, which higher scores show the stronger habit strength	Ten weeks
Secondary	Physical Activity Identity (PAI)	Physical activity self-identification 7 point likert scale. Higher score = higher physical activity identification PAI items relate to how much the participant identifies with being physically active.	Ten weeks
Secondary	The Revised Amputee Body Image Scale (ABIS-R)	This questionnaire is designed to measure how you see and feel about your body image. It is not a test so there are no right or wrong answers. Please answer each item as carefully and as accurately as you can by placing the appropriate number beside each question as follows.; Scale of 0, 1, 2. 0 = none of the time, 2 = most of the time High scores indicate high body image disturbance.	Ten weeks
Secondary	Center for Epidemiologic Studies Depression Scale (CES-D)	Below is a list of the ways you might have felt or behaved. Please tell me how often you have felt this way during the past week.; 20 items Scoring: 0, 1, 2, 3 representing "rarely" to "most of the time", respectively. The scoring of positive items is reversed. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.	Ten weeks
Secondary	Self-Report Habit Index (SRH)	Self report of limb cleaning tendencies	Ten weeks
Secondary	Activities Specific Balance Confidence (ABC) Scale	Assesses confidence in balance during different activities 16 items Each item is rated from 0% - 100% 100% indicates the participant is "completely confident" in the activity described in the item.	Ten weeks
Secondary	Residual limb pain, phantom pain, and non-painful phantom limb sensations	Residual limb pain, phantom pain, and non-painful phantom limb sensations; Participants rate their pain on each of the 3 items. Scale of 1-10 Higher score means greater reported pain	Ten weeks
Secondary	Short Musculoskeletal Function Assessment (SMFA)	Items 1-34 of a questionnaire to assess the difficulty with daily activities and experiencing problems because of injury.	Ten weeks
Secondary	Euro Quality of Life	Five Level Instrument (EQ-5D-5L) assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.	Ten weeks
Secondary	Tenacious goal pursuit (TGP)	Assesses tendency to persist and increase effort in pursuing goals facing obstacles	Ten weeks
Secondary	Action Planning Scale (AP)	Assesses whether people had formed a plan which links goal-directed behavior to environmental cues by indentifying when, where and how to act.; We will specifically assess for 'exercising', 'skin monitoring', and 'cleaning the prosthesis'.	Ten weeks
Secondary	Self-Management Assessment Scale (SMASc)	Assesses five domains that are important for an effective self-management, including "knowledge, goals for future, daily routines, emotional adjustment, and social support".	Ten weeks