Anticipated Impacts on Veterans' Healthcare: While amputation rates for veterans with diabetes have been reduced with system and provider intervention, they continue to be high. Amputation is a devastating complication that is preceded in > 80% of cases by a diabetic foot ulcer. This study applies advanced behavioral theories to intervene to improve care for Veterans at risk for amputation combined with dermal thermometry. If this promising theory-driven approach can work in a clinical setting where improvements in foot care are urgently needed for these vulnerable Veterans with a previous ulcer, it will be an important scientific contribution that coud lower the risk of recurrent ulcers and amputation in Veterans with diabetes. Project Background: Veterans with diabetes who have had a previous ulcer are at highest risk for new ulcers and amputation, particularly if they have neuropathy or vascular disease and have poor foot self-care or non- adherence to diet, medication, and exercise recommendations. It is difficult to activate at-risk patients to improve self-care and detect foot abnormalities or inflammation at an early stage, particularly when they have other risks to manage. Interventions targeting mediators of amputation risk (ulcer recurrence) promise to lower risk and improve outcomes in these high-risk Veterans. Dermal thermometry effectively allows for early identification of inflammation and is a warning sign to contact a healthcare professional. Interventions are more effective when they are behaviorally tailored and combine multiple behavioral theories. This study will evaluate a comprehensive risk-stratified personalized tailored intervention aimed to improve self-care and reduce ulcer recurrence in Veterans with diabetes and prior diabetic foot ulcer. Project Objectives: Proposed is a randomized controlled trial (RCT) testing the effectiveness of a comprehensive tailored intervention (TI) aimed to improve self-care and self-monitoring (including dermal thermometry) through behavioral counseling. The primary specific aim is to evaluate if TI reduces the proportion of recurrent ulcers at 18 months compared to the current practice (CP) group. The secondary specific aims are to evaluate the impact of TI on foot care skills, quality of life (QOL), peak plantar pressure, and step count compared to CP at 18 months. Exploratory aims will be to examine the impact of TI on amputation, gait temporal-spatial parameters, C-reactive protein, glycosylated hemoglobin (A1c) and depression at 18 months compared to CP. Project Methods: We will recruit adults with diabetes who have had a previously healed foot ulcer. Using a blinded RCT, we will test the effect of TI in relation to CP. Participants in TI will receive a comprehensive intervention including telephone counseling and tailored mailings from health counselors. The TI is an integrated, personalized intervention targeting foot self-care and self-monitoring that includes dermal thermometry as well as diet, exercise, and medication-taking incorporating the Transtheoretical Model and Prospect Theory and delivered using Motivational Interviewing principles. The intervention will be standardized and fidelity of the intervention will be maintained. Participants randomized to CP will receive enhancements current VA best practices for improving foot risk as well as telephone counseling and mailings from health counselors providing education about health prevention strategies not related to diabetes or foot care. Key outcomes are ulceration, QOL, plantar pressure, physical activity and foot care skills. Outcomes will be measured at baseline, 6, 12 and 18 months. All analyses will be intent-to-treat.

Public Health Relevance

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 improving diabetes-related foot health behavior, and other risk factors in patients who are vulnerable to devastating consequences related to amputation.

Agency
National Institute of Health (NIH)
Institute
Veterans Affairs (VA)
Type
Non-HHS Research Projects (I01)
Project #
5I01RX001858-04
Application #
9418515
Study Section
Musculoskeletal/Orthopedic Rehabilitation (RRD2)
Project Start
2015-03-01
Project End
2019-02-28
Budget Start
2018-03-01
Budget End
2019-02-28
Support Year
4
Fiscal Year
2018
Total Cost
Indirect Cost
Name
VA Medical Center
Department
Type
DUNS #
070501002
City
New York
State
NY
Country
United States
Zip Code
10010