Dysvascular Amputation Self-Management of Health (DASH)

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

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Amputation; Peripheral Artery Disease
• Intervention / Treatment: Behavioral: Walking Biobehavioral Intervention; Other: Attention Control

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Walking Biobehavioral Intervention (EXP); 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; 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.
Active Comparator: Attention Control (CTL); 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; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activities-specific Balance Confidence Scale	Change in self-reported balance confidence. Final scores range from 0% (no confidence in balance) to 100% (complete confidence in balance).	Day 0, 3 months, 6 months and 12 months
Two-Minute Walk Test	Change in the distance a participant can walk in two minutes. Use of assistive device is noted	Day 0, 3 months, 6 months and 12 months
Five Meter Walk	Change in the length of time it takes a participant to walk 5 meters, at a comfortable walking pace.	Day 0, 3 months, 6 months and 12 months
Study Intervention Reach	Percentage of eligible participants enrolled	Day 0
Outpatient Practitioner Intervention Fidelity	An individual practitioner's percent adherence to outpatient intervention protocol	Day 0 through 3 months
Biobehavioral Practitioner Intervention Fidelity	An individual interventionist's percent adherence to biobehavioral intervention protocol	Day 0 through 6 months
FitBit Use Adherence	Number of days participant uses FitBit during the no-contact phase of the study	Month 12

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Cory Christiansen, PT, PhD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): May 31, 2025
• Study Completion (Actual): May 31, 2025

Study Registration Dates

• First Submitted: August 19, 2019
• First Submitted That Met QC Criteria: September 5, 2019
• First Posted (Actual): September 10, 2019

Study Record Updates

• Last Update Posted (Actual): July 29, 2025
• Last Update Submitted That Met QC Criteria: July 28, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Diabetes; Physical Activity; Peripheral Artery Disease; Amputation; Dysvascular Amputation
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: 19-0534; R01NR018450 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The investigators will publish the trial results data on the ClinicalTrials.gov website, on which the clinical trial will be registered. Sharing of data will include the potential of sharing raw data generated from all clinical assessments under a data-sharing agreement.
• IPD Sharing Time Frame: The investigators will publish the trial results within one year of testing the final participant.
• IPD Sharing Access Criteria: User registration will be required to access/download any data and will require agreement to conditions of use in accordance with NIH Data Sharing Policy Guidelines.
• IPD Sharing Supporting Information Type: ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No