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

NCT ID: NCT02013557

Last Updated: 2016-01-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-12-31

Brief 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.

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.

Conditions

Diabetes, Gestational

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Text-message reminder

Intervention Type: BEHAVIORAL

Control group

This arm will only receive the test text-message reminder at the time of enrollment. Otherwise they will receive usual postpartum care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Text-message reminder

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of South Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Judette Louis, MD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida Department of Obstetrics and Gynecology

Angela Gonzalez, MD

Role: STUDY_CHAIR

University of South Florida Department of Obstetrics and Gynecology

Locations

Tampa General Hospital

Tampa, Florida, United States

Countries

United States

Other Identifiers

Pro00015015

Identifier Type: -

Identifier Source: org_study_id