Dysvascular Amputation Self-Management of Health (DASH)
|ClinicalTrials.gov Identifier: NCT04083456|
Recruitment Status : Active, not recruiting
First Posted : September 10, 2019
Last Update Posted : April 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Amputation Diabetes Mellitus Peripheral Artery Disease||Behavioral: Walking Biobehavioral Intervention Other: Attention Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized controlled futility design|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Improving Health Self-Management Using Walking Biobehavioral Intervention for People With Dysvascular Lower Limb Amputation|
|Actual Study Start Date :||November 1, 2019|
|Estimated Primary Completion Date :||March 1, 2024|
|Estimated Study Completion Date :||May 31, 2024|
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.
- Physical Activity [ Time Frame: Day 0 (start of conventional prosthetic rehabilitation), prosthetic rehabilitation end (3 months), intervention end (6 months), and 6 months after intervention end (12 months) ]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.
- Patient Reported Outcomes Measurement Information System (PROMIS): Self-Efficacy for Managing Symptoms [ Time Frame: Day 0, 3 months, 6 months and 12 months ]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).
- PROMIS: Self-Efficacy for Managing Daily Activities [ Time Frame: Day 0, 3 months, 6 months and 12 months ]Change in participant's confidence in managing daily activities. Final scores range from 4 points (not at all confident) to 20 points (very confident).
- PROMIS: Ability to participate in social roles and activities [ Time Frame: Day 0, 3 months, 6 months and 12 months ]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).
- Prosthesis Evaluation Questionnaire - Mobility Score [ Time Frame: Day 0, 3 months, 6 months and 12 months ]Change in self-reported mobility. Final scores range from 0 (lowest mobility) to 4 (highest mobility)
- Timed Up-and-Go test [ Time Frame: Day 0, 3 months, 6 months and 12 months ]Change in time required to rise from chair, walk 10 feet, turn around and return to sitting in same chair.
- World Health Organization-Disability Assessment Schedule 2.0 [ Time Frame: Day 0, 3 months, 6 months and 12 months ]Change in self-reported disability. Final scores range from 0 (no disability) to 100 (full disability).
- Self-Efficacy for Managing Chronic Disease [ Time Frame: Day 0, 3 months, 6 months and 12 months ]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).
- Activities-specific Balance Confidence Scale [ Time Frame: Day 0, 3 months, 6 months and 12 months ]Change in self-reported balance confidence. Final scores range from 0% (no confidence in balance) to 100% (complete confidence in balance).
- Two-Minute Walk Test [ Time Frame: Day 0, 3 months, 6 months and 12 months ]Change in the distance a participant can walk in two minutes. Use of assistive device is noted
- Five Meter Walk [ Time Frame: Day 0, 3 months, 6 months and 12 months ]Change in the length of time it takes a participant to walk 5 meters, at a comfortable walking pace.
- Study Intervention Reach [ Time Frame: Day 0 ]Percentage of eligible participants enrolled
- Outpatient Practitioner Intervention Fidelity [ Time Frame: Day 0 through 3 months ]An individual practitioner's percent adherence to outpatient intervention protocol
- Biobehavioral Practitioner Intervention Fidelity [ Time Frame: Day 0 through 6 months ]An individual interventionist's percent adherence to biobehavioral intervention protocol
- FitBit Use Adherence [ Time Frame: Month 12 ]Number of days participant uses FitBit during the no-contact phase of the study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04083456
|United States, Colorado|
|University of Colorado Hospital|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Cory Christiansen, PT, PhD||University of Colorado, Denver|