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

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

Sponsors

Lead Sponsor: Montefiore Medical Center

Source Montefiore Medical Center
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)

Overall Status Recruiting
Start Date 2020-07-08
Completion Date 2022-07-01
Primary Completion Date 2022-07-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in hemoglobin A1c (HbA1c) levels 3 months, 6 months, 1 year, 2 years
Secondary Outcome
Measure Time Frame
Change in LDL Cholesterol levels 3 months, 6 months, 1 year, 2 years
Number of Deaths 3 months, 6 months, 1 year, 2 years
Number of amputations of lower extremities 3 months, 6 months, 1 year, 2 years
Number of re-amputations 3 months, 6 months, 1 year, 2 years
Number of patients with mobility problems 3 months, 6 months, 1 year, 2 years
Enrollment 180
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Diabetes education

Description: 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.

Other Name: Sexual dysfunction in diabetes

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

Gender:

All

Gender Based:

Yes

Gender Description:

Yes all genders are eligible

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Issam Koleilat, MD Principal Investigator Montefiore Medical Center
Overall Contact

Last Name: Eelin Wilson, MD

Phone: 201-360-1316

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Montefiore Medical Center Eelin Wilson, MD 201-360-1316 [email protected]
Location Countries

United States

Verification Date

2021-05-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Montefiore Medical Center

Investigator Full Name: Jeffrey Indes

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Foot amputation, sexual health

Type: Experimental

Description: Group 1, Experimental arm: inpatient diabetics after initial minor foot amputation, who will be shown video on diabetes and foot amputations plus sexual health

Label: Foot amputation, no sexual health

Type: Active Comparator

Description: 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

Patient Data No
Study Design Info

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.

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