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

Montefiore Medicine Academic Health System

Status: Terminated

Conditions: Diabetic Foot Ulcer Ischemic; Amputation; Traumatic, Limb; Sexual Dysfunction; Diabetic Ulcers on Both Feet

Treatments: Behavioral: Diabetes education

Study type: Interventional

Funder types: Other

Identifiers

NCT04078854

2019-10489

Details and patient eligibility

About

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

Full 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)

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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21 participants in 2 patient groups

Foot amputation, sexual health

Experimental group

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

Treatment:

Behavioral: Diabetes education

Foot amputation, no sexual health

Active Comparator group

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

Treatment:

Behavioral: Diabetes education