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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Screening
|Official Title:||Text-message Reminders to Increase Rates of Postpartum Diabetes Screening in Women With Gestational Diabetes|
- Percentage of patients that receive the 2-hour 75-g oral glucose tolerance test [ Time Frame: Within six months of their delivery date ] [ Designated as safety issue: No ]
- Percentage of patients that receive any type of postpartum diabetes screening [ Time Frame: Within six months of their delivery date ] [ Designated as safety issue: No ]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.
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02013557
|Contact: Angela Gonzalez, MD||(561) firstname.lastname@example.org|
|Contact: Carolyn Young, MSN, ARNP||(813) 259-8685||ObGynClinicalResearch@health.usf.edu|
|United States, Florida|
|Tampa General Hospital||Recruiting|
|Tampa, Florida, United States, 33606|
|Sub-Investigator: Angela Gonzalez, MD|
|Sub-Investigator: Judette Louis, MD|
|Sub-Investigator: Elisabeth Sappenfield, MD|
|Sub-Investigator: Branko Miladinovic, PhD|
|Sub-Investigator: Melissa Cardenas|
|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|