Dysvascular Amputation Self-Management of Health

Diabetes Mellitus Clinical Trial

— DASH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04083456
• Other study ID #: 19-0534
• Secondary ID: R01NR018450
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: January 1, 2026

Study information

• Verified date: April 2024
• Source: University of Colorado, Denver
• Contact: Eliza A. Biondi, MS
• Phone: 303-724-6035
• Email: eliza.biondi[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Amputation
• Diabetes Mellitus
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

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.

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.

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	Study Intervention Reach	Percentage of eligible participants enrolled	Day 0
Other	Outpatient Practitioner Intervention Fidelity	An individual practitioner's percent adherence to outpatient intervention protocol	Day 0 through 3 months
Other	Biobehavioral Practitioner Intervention Fidelity	An individual interventionist's percent adherence to biobehavioral intervention protocol	Day 0 through 6 months
Other	FitBit Use Adherence	Number of days participant uses FitBit during the no-contact phase of the study	Month 12
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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