Diabetes, GestationalNCT02013557
Text-message Reminders to Increase Rates of Postpartum Diabetes Screening in Women With Gestational Diabetes
A study testing Text-message reminder in people with Diabetes, Gestational, run by University of South Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Diabetes, Gestational
- What is being tested?
- Text-message reminder
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Women that were ever diagnosed with diabetes outside of pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Text-message reminder
- Keywords
- Gestational Diabetes, Postpartum screening, Text-messages, 75-g oral glucose tolerance test
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text-message reminderBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Behavioral: Text-message reminder |
| Control group | No intervention | This arm will only receive the test text-message reminder at the time of enrollment. Otherwise they will receive usual postpartum care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients that receive the 2-hour 75-g oral glucose tolerance test
Measured: Within six months of their delivery date
Secondary outcomes (1)
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.
Measured: Within six months of their delivery date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Resources allocated elsewhere.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes, GestationalStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Judette Louis, MD, Principal investigator, University of South Florida Department of Obstetrics and GynecologyAngela Gonzalez, MD, Study chair, University of South Florida Department of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02013557
- Sponsor's protocol ID
- Pro00015015
- Status last verified
- Jan 2016
- First submitted
- 11 Dec 2013
- Last updated
- 6 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Text-message Reminders to Increase Rates of Postpartum Diabetes Screening in Women With Gestational Diabetes
- ClinicalTrials.gov ID
- NCT02013557
- Acronym / sponsor ID
- Pro00015015
- Conditions
- Diabetes, Gestational
- Keywords
- Gestational Diabetes, Postpartum screening, Text-messages, 75-g oral glucose tolerance test
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Resources allocated elsewhere.
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Text-message reminderWomen 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. |
| Control group | No intervention | –This arm will only receive the test text-message reminder at the time of enrollment. Otherwise they will receive usual postpartum care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Women that were ever diagnosed with diabetes outside of pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text-message reminder | Behavioural | Intervention Group |
Primary outcome
Percentage of patients that receive the 2-hour 75-g oral glucose tolerance test
Time frame: Within six months of their delivery date
1 secondary outcome
Percentage of patients that receive any type of postpartum diabetes screening
Time frame: Within six months of their delivery date
Results and safety
The study was stopped early (reason given: Resources allocated elsewhere.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judette Louis, MD principal investigator
University of South Florida Department of Obstetrics and Gynecology
Angela Gonzalez, MD study chair
University of South Florida Department of Obstetrics and Gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text-message reminder in people with Diabetes, Gestational, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Resources allocated elsewhere.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients that receive the 2-hour 75-g oral glucose tolerance test (time frame: Within six months of their delivery date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2016.