Clinical trial NCT02013557: Text-message Reminders to Increase Rates of Postpartum Diabetes Screening in Women With Gestational Diabetes
Official title: Text-message Reminders to Increase Rates of Postpartum Diabetes Screening in Women With Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes, Gestational
Keywords: Gestational Diabetes
Postpartum screening
Text-messages
75-g oral glucose tolerance test
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2013-12-17
Enrollment: 57
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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.

Primary outcomes:
measure: Percentage of patients that receive the 2-hour 75-g oral glucose tolerance test
timeFrame: Within six months of their delivery date
Secondary outcomes:
measure: Percentage of patients that receive any type of postpartum diabetes screening
timeFrame: Within six months of their delivery date
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
Study officials:
affiliation: University of South Florida Department of Obstetrics and Gynecology
name: Judette Louis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of South Florida Department of Obstetrics and Gynecology
name: Angela Gonzalez, MD
role: STUDY_CHAIR
References: