Text-message Reminders to Increase Rates of Postpartum Diabetes Screening in Women With Gestational Diabetes
Primary Purpose
Diabetes, Gestational
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text-message reminder
Sponsored by
About this trial
This is an interventional screening trial for Diabetes, Gestational focused on measuring Gestational Diabetes, Postpartum screening, Text-messages, 75-g oral glucose tolerance test
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.
Sites / Locations
- Tampa General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group
Control group
Arm Description
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.
This arm will only receive the test text-message reminder at the time of enrollment. Otherwise they will receive usual postpartum care.
Outcomes
Primary Outcome Measures
Percentage of patients that receive the 2-hour 75-g oral glucose tolerance test
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02013557
First Posted
December 11, 2013
Last Updated
January 5, 2016
Sponsor
University of South Florida
1. Study Identification
Unique Protocol Identification Number
NCT02013557
Brief Title
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
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
Resources allocated elsewhere.
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Gestational
Keywords
Gestational Diabetes, Postpartum screening, Text-messages, 75-g oral glucose tolerance test
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
This arm will only receive the test text-message reminder at the time of enrollment. Otherwise they will receive usual postpartum care.
Intervention Type
Behavioral
Intervention Name(s)
Text-message reminder
Primary Outcome Measure Information:
Title
Percentage of patients that receive the 2-hour 75-g oral glucose tolerance test
Time Frame
Within six months of their delivery date
Secondary Outcome Measure Information:
Title
Percentage of patients that receive any type of postpartum diabetes screening
Description
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.
Time Frame
Within six months of their delivery date
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judette Louis, MD
Organizational Affiliation
University of South Florida Department of Obstetrics and Gynecology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Angela Gonzalez, MD
Organizational Affiliation
University of South Florida Department of Obstetrics and Gynecology
Official's Role
Study Chair
Facility Information:
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Text-message Reminders to Increase Rates of Postpartum Diabetes Screening in Women With Gestational Diabetes
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