- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04953364
Self-Management for Amputee Rehabilitation Using Technology. (SMART)
Self-management for Amputee Rehabilitation Using Technology (SMART) Program: a Peer Supported mHealth Approach for Rehabilitation After Lower Limb Amputation
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SMART
The 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.
|
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.
|
Active Comparator: Control
The control group will receive a care booklet and weekly contacts for 6 weeks.
|
The control group will receive a care booklet and weekly contacts for 6 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
TUG, Timed Up and Go test
Time Frame: Ten weeks
|
The patient stands up upon therapist's command: walks 3 meters, turns around, walks back to the chair and sits down.
|
Ten weeks
|
ASCQ, the Ambulatory Self-Confidence Questionnaire
Time Frame: Ten weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-Report Habit Index (SRHI)
Time Frame: Ten weeks
|
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
|
Physical Activity Identity (PAI)
Time Frame: Ten weeks
|
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
|
The Revised Amputee Body Image Scale (ABIS-R)
Time Frame: Ten weeks
|
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
|
Center for Epidemiologic Studies Depression Scale (CES-D)
Time Frame: Ten weeks
|
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
|
Self-Report Habit Index (SRH)
Time Frame: Ten weeks
|
Self report of limb cleaning tendencies
|
Ten weeks
|
Activities Specific Balance Confidence (ABC) Scale
Time Frame: Ten weeks
|
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
|
Residual limb pain, phantom pain, and non-painful phantom limb sensations
Time Frame: Ten weeks
|
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
|
Short Musculoskeletal Function Assessment (SMFA)
Time Frame: Ten weeks
|
Items 1-34 of a questionnaire to assess the difficulty with daily activities and experiencing problems because of injury.
|
Ten weeks
|
Euro Quality of Life
Time Frame: Ten weeks
|
Five Level Instrument (EQ-5D-5L) assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
|
Ten weeks
|
Tenacious goal pursuit (TGP)
Time Frame: Ten weeks
|
Assesses tendency to persist and increase effort in pursuing goals facing obstacles
|
Ten weeks
|
Action Planning Scale (AP)
Time Frame: Ten weeks
|
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
|
Self-Management Assessment Scale (SMASc)
Time Frame: Ten weeks
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H20-03316
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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