Dysvascular Amputation Self-Management of Health

PHASE2CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

November 1, 2019

Primary Completion Date

May 31, 2025

Study Completion Date

May 31, 2025

Conditions
AmputationDiabetes MellitusPeripheral Artery Disease
Interventions
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.

Trial Locations (1)

80045

University of Colorado Hospital, Aurora

All Listed Sponsors
collaborator

National Institute of Nursing Research (NINR)

NIH

lead

University of Colorado, Denver

OTHER

NCT04083456 - Dysvascular Amputation Self-Management of Health | Biotech Hunter | Biotech Hunter