The Impact of Sexual Health and Amputation Focused Education on Regulation of Glucose and Amputation Prevention
Purpose
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
Conditions
- Diabetic Ulcers on Both Feet
- Amputation; Traumatic, Limb
- Sexual Dysfunction
- Diabetic Foot Ulcer Ischemic
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- 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.
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
- 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.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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 |
|
|
Active Comparator 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 |
|
More Details
- Status
- Terminated
- Sponsor
- Montefiore Medical Center
Study Contact
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)