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Preventing Amputations by Tailored Risk-based Intervention to Optimize Therapy

NCT02356757 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 406

Last updated 2021-10-22

No results posted yet for this study

Summary

The PATRIOT study will evaluate a risk-based personalized behavioral intervention to improve foot self-care, self-monitoring, and modifiable risks for amputation such as blood glucose, blood pressure and cholesterol in order to prevent diabetic foot ulcers in patients at higher than normal risk for amputation. This novel intervention aims to improve self-care and early detection of foot abnormalities in at-risk patients with diabetes and poor foot self-care using advanced behavioral approaches to target adherence to multiple health behaviors, including foot self-care, self-monitoring, medication adherence, dietary adherence, and physical activity simultaneously. If this promising behavioral theory-driven approach delivered using common technology (phone) to the patient at home can work in a setting where improvements in foot care are so urgent, it will be an important scientific contribution.

Conditions

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.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Sundar Natarajan, MD MSc · Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-24
Primary Completion
2021-06-30
Completion
2021-09-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02356757 on ClinicalTrials.gov