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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 : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Diabetes Foot Ulcer Behavioral: Tailored Intervention (TI) Behavioral: Current Practice (CP) Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 238 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: STEP UP to Avert Amputation in Diabetes
Actual Study Start Date : September 3, 2015
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. General Quality of Life [ Time Frame: 18 months ]
    The SF-36 will assess general well-being, and physical and mental health

  3. 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.

  4. 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.

  5. step count [ Time Frame: 18 months ]
    Step count will be assessed via accelerometer



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults (21 years) with Type 2 diabetes
  • History of healed diabetic foot ulcer (>3 months)
  • Diabetes drug 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

Information from the National Library of Medicine

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


Contacts
Contact: Sundar Natarajan, MD MSc (212) 686-5000 sundar.natarajan@va.gov
Contact: Sangmin J Hyoung, EdM (212) 686-7500 sangmin.hyoung@va.gov

Locations
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    john.hay@va.gov   
Contact: David S Goldfarb, MD    (212) 686-7500 ext 3877    David.Goldfarb@va.gov   
Principal Investigator: Sundar Natarajan, MD MSc         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Sundar Natarajan, MD MSc Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02356848     History of Changes
Other Study ID Numbers: E1858-R
First Posted: February 5, 2015    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
self-care
self-monitoring
secondary prevention
foot ulcer

Additional relevant MeSH terms:
Diabetes Mellitus
Foot Ulcer
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer