The Impact of Sexual Health and Amputation Focused Education on Regulation of Glucose and Amputation Prevention

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effect of two types of education on HbA1c level and future amputations in inpatient diabetics after initial minor foot amputation

Detailed Description
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This is a single center prospective randomized study evaluating inpatient diabetics after initial minor foot amputations. 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)

Official Title
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The Impact of Sexual Health and Amputation Focused Education on Regulation of Glucose and Amputation Prevention (SAFER GAP)

Conditions
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Diabetic Ulcers on Both Feet, Amputation; Traumatic, Limb, Sexual Dysfunction, Diabetic Foot Ulcer Ischemic

Intervention / Treatment
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* Behavioral: Diabetes education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HbA1c 6.5 and above had minor foot amputation this hospitalization Age 18 years old and older All ethnicities Both genders Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Foot amputation, sexual health<br>Group 1, Experimental arm: inpatient diabetics after initial minor foot amputation, who will be shown video on diabetes and foot amputations plus sexual health | Behavioral: Diabetes education<br>* 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.<br>* Other names: Sexual dysfunction in diabetes;|
| Active Comparator: Foot amputation, no sexual health<br>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 | Behavioral: Diabetes education<br>* 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.<br>* Other names: Sexual dysfunction in diabetes;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hemoglobin A1c (HbA1c) levels | HbA1c measures the amount of blood sugar (glucose) attached to hemoglobin | 3 months, 6 months, 1 year, 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in LDL Cholesterol levels | LDL | 3 months, 6 months, 1 year, 2 years | 
| Number of Deaths | Mortality | 3 months, 6 months, 1 year, 2 years | 
| Number of amputations of lower extremities | Amputation | 3 months, 6 months, 1 year, 2 years | 
| Number of re-amputations | higher level or contralateral leg | 3 months, 6 months, 1 year, 2 years | 
| Number of patients with mobility problems | Number of blocks patient can walk before claudication | 3 months, 6 months, 1 year, 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Foot, Sexual Dysfunction, Amputation