STEP UP to Avert Amputation in Diabetes (STEP UP)
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|ClinicalTrials.gov Identifier: NCT02356848|
Recruitment Status : Recruiting
First Posted : February 5, 2015
Last Update Posted : February 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Foot Ulcer||Behavioral: Tailored Intervention (TI) Behavioral: Current Practice (CP)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||238 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||STEP UP to Avert Amputation in Diabetes|
|Actual Study Start Date :||September 3, 2015|
|Estimated Primary Completion Date :||May 1, 2020|
|Estimated Study Completion Date :||May 31, 2020|
Experimental: 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.
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.
Placebo Comparator: 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
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.
- Ulceration [ Time Frame: 18 months ]High-resolution standard view digital photographs of the feet and footwear will be obtained and reviewed by the investigators blinded to group assignment, and a suspected ulcer or nonulcerative plantar lesion below the malleoli will be referred to a panel of three blinded (as to group assignment) adjudicators, all clinical experts. Lesions will be judged as absent/nonulcerative lesion/ulcer; involving/not involving the plantar surface (defined as involving the weight-bearing surface of the foot); and related to metatarsal head (MTH)/not related to MTH. Adjudicators will not confer with each other or with the study staff, and the majority opinion will be taken as the final judgment. Ulcers will be judged to be present if the integrity of both the epidermis and dermis is broken. When ulcers occur in between study visits, the adjudication committee will review the medical records and make the determination.
- Foot care skills [ Time Frame: 18 months ]The investigators will use the Veterans foot self-care education and behavior survey to assess different subscales of foot care. The investigators will measure basic foot-care education, extended foot-care education, basic professional foot care, extended professional foot care, basic foot self-care, and extended foot self-care using this survey that was developed and validated in high-risk Veterans.
- General Quality of Life [ Time Frame: 18 months ]The SF-36 will assess general well-being, and physical and mental health
- Foot health-specific quality of life [ Time Frame: 18 months ]The Foot Health Status Questionnaire (FHSQ),93 a reliable and valid instrument, will measure foot health-related quality of life.
- plantar pressure [ Time Frame: 18 months ]Plantar pressure measurements will be used to identify specific areas of high pressure under the foot. Plantar forces and pressures will be recorded during level barefoot walking using the TekScan High Resolution (HR) MatScan system.
- step count [ Time Frame: 18 months ]Step count will be assessed via accelerometer
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02356848
|Contact: Sundar Natarajan, MD MSc||(212) firstname.lastname@example.org|
|Contact: Sangmin J Hyoung, EdM||(212) email@example.com|
|United States, New York|
|Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY||Recruiting|
|New York, New York, United States, 10010|
|Contact: John G Hay, MD 212-686-7500 ext 3860 firstname.lastname@example.org|
|Contact: David S Goldfarb, MD (212) 686-7500 ext 3877 David.Goldfarb@va.gov|
|Principal Investigator: Sundar Natarajan, MD MSc|
|Principal Investigator:||Sundar Natarajan, MD MSc||Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY|