STEP UP to Avert Amputation in Diabetes

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT02356848
Collaborator
(none)
241
Enrollment
1
Location
2
Arms
72.9
Actual Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
  • Behavioral: Tailored Intervention (TI)
  • Behavioral: Current Practice (CP)
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
241 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 :
Sep 3, 2015
Actual Primary Completion Date :
Jun 30, 2021
Actual Study Completion Date :
Sep 30, 2021

Arms and Interventions

ArmIntervention/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.

Outcome Measures

Primary Outcome Measures

  1. Ulceration [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 [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 [18 months]

    The SF-36 will assess general well-being, and physical and mental health

  3. Foot health-specific quality of life [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 [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 [18 months]

    Step count will be assessed via accelerometer

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Manhattan Campus of the VA NY Harbor Healthcare System, New York, NYNew YorkNew YorkUnited States10010

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT02356848
Other Study ID Numbers:
  • E1858-R
First Posted:
Feb 5, 2015
Last Update Posted:
Oct 8, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 8, 2021