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临床试验/NCT04078854
NCT04078854终止不适用

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

Montefiore Medical Center1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2020年7月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
21
试验地点
1
主要终点
Change in hemoglobin A1c (HbA1c) levels

研究概览

简要总结

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

详细描述

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)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • HbA1c 6.5 and above
  • had minor foot amputation this hospitalization
  • Age 18 years old and older
  • All ethnicities
  • Both genders

排除标准

  • 未提供

研究组 & 干预措施

Foot amputation, sexual health

Experimental

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

干预措施: Diabetes education (Behavioral)

Foot amputation, no sexual health

Active Comparator

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

干预措施: Diabetes education (Behavioral)

结局指标

主要结局

Change in hemoglobin A1c (HbA1c) levels

时间窗: 3 months, 6 months, 1 year, 2 years

HbA1c measures the amount of blood sugar (glucose) attached to hemoglobin

次要结局

  • 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)
  • Change in LDL Cholesterol levels(3 months, 6 months, 1 year, 2 years)
  • Number of Deaths(3 months, 6 months, 1 year, 2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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