Dysvascular Amputation Self-Management of Health

Study Overview
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Brief Summary
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The purpose of this study is to determine if walking biobehavioral intervention improves physical activity after dysvascular lower limb amputation.

Detailed Description
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Sedentary lifestyles and high levels of disability are relevant public and personal health issues resulting from the chronic comorbid condition of dysvascular lower limb amputation. This study examines the use of an evidence-based walking biobehavioral intervention to increase physical activity after dysvascular amputation. The proposed intervention leverages successes in conventional prosthetic rehabilitation, while addressing the complex health conditions and chronic sedentary behaviors that underlie dysvascular amputation, with the ultimate goal of improved physical activity self-management to minimize disability.

Official Title
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Improving Health Self-Management Using Walking Biobehavioral Intervention for People With Dysvascular Lower Limb Amputation

Conditions
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Diabetes Mellitus, Amputation, Peripheral Artery Disease

Intervention / Treatment
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* Behavioral: Walking Biobehavioral Intervention
* Other: Attention Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Within the age range of 50-85 years Confirmed diagnosis of Type II Diabetes Mellitus (DM) and/or Peripheral Artery Disease (PAD) Transtibial, knee disarticulation, or transfemoral lower-limb amputation (LLA) (or re-amputation) within the past 12 months Participant goal of household walking or better using a prosthesis Exclusion Criteria: Trauma or cancer-related etiology of the LLA Decisionally challenged individuals (MMSE score below 24) Prisoners Active cancer treatment Recent stroke (within 2 years) Clinical discretion of principal investigator to exclude patients who are determined to be unsafe and/or inappropriate to participate in the described intervention.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled futility design
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Walking Biobehavioral Intervention (EXP)<br>The EXP group will receive biobehavioral training that is integrated into the conventional outpatient training component and is delivered over 5 months. There will be 10 biobehavioral sessions, 1 of which will be a combined biobehavioral/conventional outpatient session and the other 9 being telehealth sessions. | Behavioral: Walking Biobehavioral Intervention<br>* Each walking biobehavioral training session includes self-monitoring, tailored feedback, identification of barriers and facilitators, problem solving, action planning and encouragement. Self-monitoring of walking behavior will occur with participant use of the FitBit sensor and software, reviewed with the interventionist at each session. Tailored feedback from the FitBit sensor, as well as feedback from the interventionist, will detail progress over time and be compared to baseline data. Barriers and facilitators of reaching activity goals will be discussed with emphasis on problem solving to take advantage of facilitators and minimize/remove participant-specific barriers. Action planning will be based on weekly step goals set collaboratively by the interventionist and participant, based the FitBit data. Finally, encouragement will be provided by the interventionist by putting progress or lack of progress in perspective of the efforts made by the participant.<br>|
| Active Comparator: Attention Control (CTL)<br>The CTL group intervention will include the same conventional outpatient training (10 sessions) as the EXP group and receive the same computer tablets with telehealth software as the EXP group (week 3 of prosthetic training). | Other: Attention Control<br>* Attention control sessions will include a brief review of the conventional home-exercises, a summary of all healthcare visits and falls, and interventionist-delivered education on safety topics (e.g., fall prevention, wound care, assistive device use). Outpatient therapists will provide home-based exercises to ensure that the participant receives adequate training and demonstrates safe performance prior to home use. The CTL interventionist will assess and discuss the safe performance of each home-based exercise with CTL group participants. Exercises in the CTL group will only be progressed by the outpatient physical therapist and not during the telehealth sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity | Change in 10 day physical activity step count with ActivPAL activity monitor between the beginning of conventional prosthetic rehabilitation to the end of intervention. Maintenance will be observed at six months after the end of the intervention. | Day 0 (start of conventional prosthetic rehabilitation), prosthetic rehabilitation end (3 months), intervention end (6 months), and 6 months after intervention end (12 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Reported Outcomes Measurement Information System (PROMIS): Self-Efficacy for Managing Symptoms | Change in participant's confidence in managing symptoms of chronic disease. Final scores range from 4 points (not at all confident) to 20 points (very confident). | Day 0, 3 months, 6 months and 12 months | 
| PROMIS: Self-Efficacy for Managing Daily Activities | Change in participant's confidence in managing daily activities. Final scores range from 4 points (not at all confident) to 20 points (very confident). | Day 0, 3 months, 6 months and 12 months | 
| PROMIS: Ability to participate in social roles and activities | Change in participant's ability to participate in social roles and activities. Final scores range from 8 points (never participates) to 40 points (always participates). | Day 0, 3 months, 6 months and 12 months | 
| Prosthesis Evaluation Questionnaire - Mobility Score | Change in self-reported mobility. Final scores range from 0 (lowest mobility) to 4 (highest mobility) | Day 0, 3 months, 6 months and 12 months | 
| Timed Up-and-Go test | Change in time required to rise from chair, walk 10 feet, turn around and return to sitting in same chair. | Day 0, 3 months, 6 months and 12 months | 
| World Health Organization-Disability Assessment Schedule 2.0 | Change in self-reported disability. Final scores range from 0 (no disability) to 100 (full disability). | Day 0, 3 months, 6 months and 12 months | 
| Self-Efficacy for Managing Chronic Disease | Change in self-reported confidence in managing different aspects of chronic disease. Final scores range from 1 (not at all confident in managing chronic disease) to 10 (totally confident in managing chronic disease). | Day 0, 3 months, 6 months and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amputation, Dysvascular Amputation, Diabetes, Peripheral Artery Disease, Physical Activity