Preventing Amputations by Tailored Risk-based Intervention to Optimize Therapy

NACompletedINTERVENTIONAL
Enrollment

406

Participants

Timeline

Start Date

August 24, 2015

Primary Completion Date

June 30, 2021

Study Completion Date

September 30, 2021

Conditions
DiabetesFoot Ulcer
Interventions
BEHAVIORAL

Personalized Behavioral Intervention

The PBI is based on self-regulation theory, the Transtheoretical Model and Prospect Theory, and will be delivered using Motivational Interviewing principles and the teach-back method. Participants will receive monthly calls targeting foot self-care, foot self-monitoring, diet, medication and physical activity for 6 months. Call/mailing frequency during the next 6 months will depend on adherence level to foot self-care and self-monitoring at 6 months.

BEHAVIORAL

Current Best Practice

CBP will include monthly calls from a counselor focusing on preventing conditions like colorectal cancer, flu, insomnia, vision problems, memory loss and oral disease for the first 6 months. Frequency of calls and mailings from counselors during the next 6 months will be determined by level of adherence to preventive strategies during the first 6 months.

Trial Locations (1)

10010

Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY, New York

All Listed Sponsors
lead

VA Office of Research and Development

FED

NCT02356757 - Preventing Amputations by Tailored Risk-based Intervention to Optimize Therapy | Biotech Hunter | Biotech Hunter