STEP UP to Avert Amputation in Diabetes
STEP UP
1 other identifier
interventional
241
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes
Started Sep 2015
Longer than P75 for not_applicable diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2015
CompletedFirst Posted
Study publicly available on registry
February 5, 2015
CompletedStudy Start
First participant enrolled
September 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2021
CompletedOctober 8, 2021
October 1, 2021
5.8 years
February 2, 2015
October 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ulceration
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.
18 months
Secondary Outcomes (5)
Foot care skills
18 months
General Quality of Life
18 months
Foot health-specific quality of life
18 months
plantar pressure
18 months
step count
18 months
Study Arms (2)
Tailored intervention (TI)
EXPERIMENTALParticipants 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.
Current Practice (CP)
PLACEBO COMPARATORThis 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
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
New York, New York, 10010, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sundar Natarajan, MD MSc
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2015
First Posted
February 5, 2015
Study Start
September 3, 2015
Primary Completion
June 30, 2021
Study Completion
September 30, 2021
Last Updated
October 8, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share