Self-Management for Amputee Rehabilitation Using Technology.

NCT ID: NCT04953364

Last Updated: 2024-07-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-14
• Study Completion Date: 2026-02-01

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.

Conditions

Behavior; Amputation; Lower Limb Amputation Above Knee (Injury); Lower Limb Amputation Below Knee (Injury); Lower Limb Amputation Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

SMART

Intervention Type: BEHAVIORAL

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.

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: BEHAVIORAL

The control group will receive a care booklet and weekly contacts for 6 weeks.

Interventions

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.

Intervention Type: BEHAVIORAL

Control

The control group will receive a care booklet and weekly contacts for 6 weeks.

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

William C. Miller

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William C Miller, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of British Columbia

Locations

GF Strong Rehabilitation Centre

Vancouver, British Columbia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

William C Miller, PhD

Role: CONTACT

bill.miller@ubc.ca

+1 (604) 312-5245

Facility Contacts

William C Miller, PhD

Role: primary

bill.miller@ubc.ca

+1 (604) 312-5245

References

Esfandiari E, Miller WC, King S, Payne M, Mortenson WB, Underwood H, MacKay C, Ashe MC. Protocol for a randomized controlled trial to assess the effect of Self-Management for Amputee Rehabilitation using Technology (SMART): An online self-management program for individuals with lower limb loss. PLoS One. 2023 Mar 23;18(3):e0278418. doi: 10.1371/journal.pone.0278418. eCollection 2023.

Reference Type: DERIVED

PMID: 36952517 (View on PubMed)

Other Identifiers

H20-03316

Identifier Type: -

Identifier Source: org_study_id