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

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.

Study Overview

• Status: Terminated
• Conditions: Diabetes, Gestational
• Intervention / Treatment: Behavioral: Text-message reminder

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention 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.	Behavioral: Text-message reminder
No Intervention: Control group; This arm will only receive the test text-message reminder at the time of enrollment. Otherwise they will receive usual postpartum care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients that receive the 2-hour 75-g oral glucose tolerance test	Within six months of their delivery date

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of South Florida
• Investigators: Principal Investigator: Judette Louis, MD, University of South Florida Department of Obstetrics and Gynecology; Study Chair: Angela Gonzalez, MD, University of South Florida Department of Obstetrics and Gynecology

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: December 11, 2013
• First Submitted That Met QC Criteria: December 11, 2013
• First Posted (Estimate): December 17, 2013

Study Record Updates

• Last Update Posted (Estimate): January 6, 2016
• Last Update Submitted That Met QC Criteria: January 5, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Gestational Diabetes; Text-messages; Postpartum screening; 75-g oral glucose tolerance test
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: Pro00015015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO