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STEP UP to Avert Amputation in Diabetes

NCT02356848 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 241

Last updated 2021-10-08

No results posted yet for this study

Summary

This study will evaluate a comprehensive tailored behavioral intervention aimed to improve foot self-care and self-monitoring (combined with dermal thermometry) to prevent recurrent ulcers in Veterans at highest risk of amputation. This intervention may be a novel strategy for improving self-care and early detection of foot abnormalities in this at-risk population using psychological theories to target multiple health behaviors simultaneously. This could be an efficient and cost-effective approach to improve diabetes-related foot health behavior, and other risk factors in patients who are vulnerable to devastating consequences related to amputation.

Conditions

Interventions

BEHAVIORAL

Tailored Intervention (TI)

Participants in this arm will receive a comprehensive intervention based on the Transtheoretical Model and Prospect Theory with the counseling being delivered by health counselors using MI principles.

BEHAVIORAL

Current Practice (CP)

this group will receive calls and mailings focusing on providing education and prevention strategies for health conditions such as colorectal cancer, influenza, insomnia, vision, dementia, and oral disease.

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
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-03
Primary Completion
2021-06-30
Completion
2021-09-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT02356848 on ClinicalTrials.gov