Amputation; Traumatic, Limb, Diabetic Foot Ulcer Ischemic, Diabetic Ulcers on Both Feet, Sexual Dysfunction
Conditions
Keywords
Diabetic Foot, Sexual Dysfunction, Amputation
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
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)
Interventions
BEHAVIORALDiabetes 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.
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Participants do not know that there are two types of presentations. When a potential enrollee has been identified, while still inpatient, one research associate from a group of trained residents or medical students will spend 15 to 30 minutes with the patient to enroll and give one of the two education video presentations. The patients will be randomized to one of the two presentations.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in hemoglobin A1c (HbA1c) levels | 3 months, 6 months, 1 year, 2 years | HbA1c measures the amount of blood sugar (glucose) attached to hemoglobin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in LDL Cholesterol levels | 3 months, 6 months, 1 year, 2 years | LDL |
| Number of Deaths | 3 months, 6 months, 1 year, 2 years | Mortality |
| Number of amputations of lower extremities | 3 months, 6 months, 1 year, 2 years | Amputation |
| Number of re-amputations | 3 months, 6 months, 1 year, 2 years | higher level or contralateral leg |
| Number of patients with mobility problems | 3 months, 6 months, 1 year, 2 years | Number of blocks patient can walk before claudication |
Countries
United States
Outcome results
None listed