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临床试验/NCT02013557
NCT02013557终止不适用

Text-message Reminders to Increase Rates of Postpartum Diabetes Screening in Women With Gestational Diabetes

University of South Florida2 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
57
试验地点
2
主要终点
Percentage of patients that receive the 2-hour 75-g oral glucose tolerance test

研究概览

简要总结

Purpose: The purpose of this study is to see whether a text-message reminder system will increase the number of women who complete their diabetes screening after delivery.

Study Design: Prospective randomized control trial

Hypothesis: Gestational diabetics will be significantly more likely to follow up with their postpartum screening for diabetes if they receive text-message reminders to set up their lab appointment compared to those who receive usual care.

详细描述

Eligible participants will be recruited after delivery while on the postpartum ward. Recruitment will be conducted by the PI or a member of the study team. After informed consent is obtained, the patients will be randomized into one of two study groups: the intervention group or the control group. Women in the intervention group will receive a test text-message reminder at the time of enrollment. They will then receive a text-reminder to schedule their oral glucose tolerance test at 6 weeks postpartum, with further reminders at 3 months and 6 months if they have not completed their testing. Women in the control group will only receive the test text-message reminder. The PI or member of the study team obtaining the informed consent will verify the participant has received the text-message prior to completing enrollment. A computer-generated randomization list will be generated according to intervention vs. control group. Simple randomization will be used for the purposes of this study. 316 participants will be recruited based on the sample size calculations already performed. One group of 316 randomized opaque envelopes will be prepared. These sealed envelopes will be stored in a secured designated area at Tampa General Hospital. Once a patient has agreed to participate and is consented an envelope will be selected from the next sequentially numbered envelope and the number on the envelope will be recorded on their study sheet. Enrollment will continue until 316 participants have been recruited.

研究设计

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

入排标准

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

入选标准

  • Women diagnosed with gestational diabetes (GDM) based on a 100-g, 3-hour glucose tolerance test with 2 or more abnormal values according to the Carpenter-Coustan criteria OR Women with a 50-g, 1-hour loading test >200mg/dl.
  • Diagnosed with GDM at least at 24 weeks gestation or later
  • Access to a personal mobile phone with text-messaging capabilities.
  • Age 18 or greater
  • Able to provide written and informed consent in English or Spanish language

排除标准

  • Women that were ever diagnosed with diabetes outside of pregnancy.

结局指标

主要结局

Percentage of patients that receive the 2-hour 75-g oral glucose tolerance test

时间窗: Within six months of their delivery date

次要结局

  • Percentage of patients that receive any type of postpartum diabetes screening(Within six months of their delivery date)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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