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
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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
21
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.
Montefiore Medical Center
The Bronx, New York, United States
Change in hemoglobin A1c (HbA1c) levels
HbA1c measures the amount of blood sugar (glucose) attached to hemoglobin
Time frame: 3 months, 6 months, 1 year, 2 years
Change in LDL Cholesterol levels
LDL
Time frame: 3 months, 6 months, 1 year, 2 years
Number of Deaths
Mortality
Time frame: 3 months, 6 months, 1 year, 2 years
Number of amputations of lower extremities
Amputation
Time frame: 3 months, 6 months, 1 year, 2 years
Number of re-amputations
higher level or contralateral leg
Time frame: 3 months, 6 months, 1 year, 2 years
Number of patients with mobility problems
Number of blocks patient can walk before claudication
Time frame: 3 months, 6 months, 1 year, 2 years
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