STEP UP to Avert Amputation in Diabetes

NCT ID: NCT02356848

Last Updated: 2021-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 241 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-03
• Study Completion Date: 2021-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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. This arm will have biweekly calls for the first two months and then monthly calls for the next four months followed by texts or mailings for months 7-18 with the frequency determine by level of treatment adherence.

Group Type: EXPERIMENTAL

Tailored Intervention (TI)

Intervention Type: BEHAVIORAL

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.

Current Practice (CP)

This group will receive all the enhancements that the VA has targeted to improve foot risk in diabetes including full EMR functionality, clinical reminders to improve care, and Patient-Centered Medical Home (PCMH) implementation with its benefits for diabetes care. To control for attention and preserve blinding, 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. This arm will have biweekly calls for the first two months and then monthly calls for the next four months followed by texts or mailings for months 7-18 with the frequency determine by level of treatment adherence to general health recommendations

Group Type: PLACEBO_COMPARATOR

Current Practice (CP)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Adults (21 years) with Type 2 diabetes
• History of healed diabetic foot ulcer (>3 months)
• Diabetes therapy for > 6 months
• An available phone and receiving continuity of care at the VA (at least 2 primary care visits in the previous 1.5 years at the recruitment site)

Exclusion Criteria

• Patients with an active foot ulcer
• Acute cardiovascular disease (CVD) events < 3 months ago
• Poor estimated short-term survival (< 1 year)
• Recent major surgery (< 3 months)
• Prior foot amputation
• Inability to exercise
• Temporary residence in the area
• Inability to provide consent will be excluded

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sundar Natarajan, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

Locations

Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

New York, New York, United States

Countries

United States

Other Identifiers

E1858-R

Identifier Type: -

Identifier Source: org_study_id