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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University of South Florida
Sponsor:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT02013557
First received: December 11, 2013
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Diabetes, Gestational
Behavioral: Text-message reminder

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 316
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)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02013557

Contacts
Contact: Elisabeth Sappenfield, MD (850) 544-5237 esappenf@health.usf.edu
Contact: Carolyn Young, MSN, ARNP (813) 259-8685 ObGynClinicalResearch@health.usf.edu

Locations
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         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT02013557     History of Changes
Other Study ID Numbers: Pro00015015
Study First Received: December 11, 2013
Last Updated: October 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Florida:
Gestational Diabetes
Postpartum screening
Text-messages
75-g oral glucose tolerance test

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on November 20, 2014