BACKGROUND/RATIONALE:
Veterans with diabetes are at high risk for foot ulcers and amputations, particularly if they have neuropathy, vascular disease or anatomic abnormalities, and have poor foot self-care, poor foot self-monitoring and/or nonadherence to diet, medication, and exercise. It is difficult to activate at-risk Veterans to improve self-care and self-monitoring, and lower other amputation risks such as glycosylated hemoglobin A1c and other risk factors.

OBJECTIVE(S):
We are conducting a randomized controlled trial testing the effectiveness of a comprehensive personalized behavioral intervention (PBI) aimed to improve foot self-care, foot self-monitoring, and modifiable risks for amputation such as peripheral vascular disease (PVD), glycosylated hemoglobin (A1c), blood pressure (BP) and low-density lipoprotein (LDL) using behavioral counseling combined with dermal thermometry. The primary specific aim is to evaluate the effect of PBI on the proportion of ulcerative and non-ulcerative lesions compared to current best practice (CBP) in diabetes. The secondary specific aims are to evaluate the impact of PBI, compared to CBP, on foot self-care skills, foot education and adherence, A1c, BP and LDL, and quality of life at 6 months; its longer-term effects at 12 months on the aforementioned outcomes; and cost-effectiveness.

METHODS:
We will randomize 404 Veterans with diabetes who are at higher than normal risk of foot ulcers [Preventing Amputations in Veterans Everywhere (PAVE) score of 1, 2, or 3 (with no history of ulcers or amputations)]. The interventions will be standardized and fidelity of the intervention will be maintained. Using a blinded randomized controlled trial (RCT) design, we will test the effect of PBI in relation to CBP. Key outcomes are non-ulcerative and ulcerative lesions, foot-care skills, foot care education, adherence to diet and medication, general and foot health-specific quality of life, A1c, BP, and LDL. Outcomes will be measured at baseline, 6 and 12 months. All analyses will be intent-to-treat.

FINDINGS/RESULTS:
Data collection is ongoing. We have enrolled 393 participants and randomized 327 participants by 3/27/18.

IMPACT:
This study evaluates a comprehensive risk-stratified PBI targeting multiple behaviors related to self-care, self-monitoring and amputation risk. This study applies advanced behavioral theories to intervene and improve care for Veterans at risk for amputation. If this promising theory-driven approach can work in a clinical setting where improvements in foot care are urgently needed, it will be an important contribution that could lower the risk of amputation in Veterans with diabetes.

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External Links for this Project

NIH Reporter

Grant Number: I01HX001580-01A1
Link: https://reporter.nih.gov/project-details/8868556

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PUBLICATIONS:

Journal Articles

1. Salovaara PK, Li C, Nicholson A, Lipsitz SR, Natarajan S. Navigating COVID-19 and related challenges to completing clinical trials: Lessons from the PATRIOT and STEP-UP randomized prevention trials. Clinical trials (London, England). 2023 Apr 1; 20(2):153-165. [view]

DRA: Aging, Older Veterans' Health and Care, Diabetes and Other Endocrine Disorders
DRE: Prevention
Keywords: Adherence, Cost-Effectiveness, Diabetes, Outcomes - Patient, Self-Care
MeSH Terms: none