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

Diabetes, Gestational Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02013557
• Other study ID #: Pro00015015
• Status: Terminated
• Phase: N/A
• First received: December 11, 2013
• Last updated: January 5, 2016
• Start date: January 2014
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 57
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Screening

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational

Intervention

Behavioral:
• Text-message reminder

Locations

Country	Name	City	State
United States	Tampa General Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients that receive the 2-hour 75-g oral glucose tolerance test		Within six months of their delivery date	No
Secondary	Percentage of patients that receive any type of postpartum diabetes screening	This can include any of the multiple forms of diabetes screening tests including: 75-g oral glucose tolerance test, Hemoglobin A1c, fasting plasma glucose test or others.	Within six months of their delivery date	No