The Impact of Sexual Health and Amputation Focused Education on Regulation of Glucose and Amputation Prevention
NCT ID: NCT04078854
Last Updated: 2023-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
21 participants
INTERVENTIONAL
2020-07-08
2022-03-16
Brief Summary
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Detailed Description
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b) When a potential enrollee has been identified, while still inpatient, one research associate from a group of trained residents and medical students will spend 15-30 minutes with the patient to enroll and give one of the two education video presentations. The video presentations are the narrated versions of the slides attached to the IRB application. We will have both English and Spanish videos available. Because we are using video education, the education provided will be standardized across all patients, and there will be minimal variation in education provided despite using different research associates. The patients will be randomized to one of the two presentations. Both presentations are identical in educating patients how to control diabetes and the risk of future amputations in diabetes, but the experimental arm presentation will also include information regarding sexual dysfunction in diabetes. Each enrollee will also be asked if they are receiving structured diabetes education at the Montefiore Diabetic Center and will be encouraged to follow up to receive structured education there.
The education presentation will occur after post-operative day 1 after minor foot amputations.
Primary Outcome: HbA1c level Secondary Outcomes: LDL level, Mortality, Re-amputation (higher level or contralateral leg)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Foot amputation, sexual health
Group 1, Experimental arm: inpatient diabetics after initial minor foot amputation, who will be shown video on diabetes and foot amputations plus sexual health
Diabetes education
Both presentations are identical in educating patients how to control diabetes and the risk of future amputations in diabetes, but the experimental arm presentation will also include information regarding sexual dysfunction in diabetes.
Foot amputation, no sexual health
Group 2, Control arm: inpatient diabetics after initial minor foot amputation, who will be shown video on diabetes and foot amputations, with no mention about sexual health
Diabetes education
Both presentations are identical in educating patients how to control diabetes and the risk of future amputations in diabetes, but the experimental arm presentation will also include information regarding sexual dysfunction in diabetes.
Interventions
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Diabetes education
Both presentations are identical in educating patients how to control diabetes and the risk of future amputations in diabetes, but the experimental arm presentation will also include information regarding sexual dysfunction in diabetes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* had minor foot amputation this hospitalization
* Age 18 years old and older
* All ethnicities
* Both genders
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Montefiore Medical Center
OTHER
Responsible Party
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Principal Investigators
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Issam Koleilat, MD
Role: PRINCIPAL_INVESTIGATOR
Montefiore Medical Center
Locations
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Montefiore Medical Center
The Bronx, New York, United States
Countries
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Other Identifiers
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2019-10489
Identifier Type: -
Identifier Source: org_study_id
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