NCT02356848

STEP UP to Avert Amputation in Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 241 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 nonadherence 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. Proposed is a randomized controlled trial 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 time to ulceration, quality of life (QOL), plantar pressure, physical activity and foot care skills compared to the CP group. The investigators will recruit adults with diabetes who have had a previously healed ulcer. The intervention will be standardized and fidelity of the intervention will be maintained. Using a blinded randomized controlled trial (RCT), the investigators will test the effect of TI in relation to CP. Key outcomes are ulceration, quality of life (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. This study will evaluate a comprehensive tailored intervention targeting multiple behaviors related to self-care and amputation risk. 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 could lower the risk of recurrent ulcers and amputation in Veterans with diabetes.

Conditions

• Diabetes
• Foot Ulcer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-09-03
• Primary completion: 2021-06-30
• Completion: 2021-09-30
• First posted: 2015-02-05
• Last updated: 2021-10-08

Locations

1 site across 1 country: United States