Brief Summary
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
Brief Title
The Impact of Sexual Health and Amputation Focused Education on Regulation of Glucose and Amputation Prevention
Detailed Description
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)
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)
Categories
Completion Date
Completion Date Type
Actual
Conditions
Diabetic Ulcers on Both Feet
Amputation; Traumatic, Limb
Sexual Dysfunction
Diabetic Foot Ulcer Ischemic
Eligibility Criteria
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
* HbA1c 6.5 and above
* had minor foot amputation this hospitalization
* Age 18 years old and older
* All ethnicities
* Both genders
Exclusion Criteria:
None
Inclusion Criteria
Inclusion Criteria:
* HbA1c 6.5 and above
* had minor foot amputation this hospitalization
* Age 18 years old and older
* All ethnicities
* Both genders
* HbA1c 6.5 and above
* had minor foot amputation this hospitalization
* Age 18 years old and older
* All ethnicities
* Both genders
Gender
All
Gender Based
false
Keywords
Diabetic Foot
Sexual Dysfunction
Amputation
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04078854
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2019-10489
Overall Status
Terminated
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
The Impact of Sexual Health and Amputation Focused Education on Regulation of Glucose and Amputation Prevention (SAFER GAP)
Primary Outcomes
Outcome Description
HbA1c measures the amount of blood sugar (glucose) attached to hemoglobin
Outcome Measure
Change in hemoglobin A1c (HbA1c) levels
Outcome Time Frame
3 months, 6 months, 1 year, 2 years
Secondary Outcomes
Outcome Description
LDL
Outcome Time Frame
3 months, 6 months, 1 year, 2 years
Outcome Measure
Change in LDL Cholesterol levels
Outcome Description
Mortality
Outcome Time Frame
3 months, 6 months, 1 year, 2 years
Outcome Measure
Number of Deaths
Outcome Description
Amputation
Outcome Time Frame
3 months, 6 months, 1 year, 2 years
Outcome Measure
Number of amputations of lower extremities
Outcome Description
higher level or contralateral leg
Outcome Time Frame
3 months, 6 months, 1 year, 2 years
Outcome Measure
Number of re-amputations
Outcome Description
Number of blocks patient can walk before claudication
Outcome Time Frame
3 months, 6 months, 1 year, 2 years
Outcome Measure
Number of patients with mobility problems
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jeffrey Indes
Investigator Email
jindes@montefiore.org
Investigator Phone