Texting for Diabetes Success in Pregnancy
Primary Purpose
Gestational Diabetes, Pregnancy in Diabetics
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Texting group
Sponsored by
About this trial
This is an interventional other trial for Gestational Diabetes
Eligibility Criteria
Inclusion Criteria:
- Pregnant
- English-speaking
- Have gestational diabetes mellitus, type 2 diabetes mellitus, or type 1 diabetes mellitus
- Age 18 years or older
- Access to a phone that can receive text messages
Exclusion Criteria:
- Gestational age greater than 30 weeks
- Women not meeting the above inclusion criteria
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Texting
Arm Description
Texting group
Outcomes
Primary Outcome Measures
Patient satisfaction and feedback
A single qualitative interview of patient perspectives and areas for improvement in the text messaging program. Interview takes place between 35 weeks gestation and discharge after delivery (postpartum day 2)
Secondary Outcome Measures
Diabetes self-efficacy (Measured using the Diabetes Empowerment Scale-Short Form)
Assessment of diabetes self-efficacy. Survey takes place after 35 weeks gestation and before discharge after delivery (postpartum day 2)
Barriers and facilitators of diabetes self-management
Qualitative interview of patient experiences regarding having diabetes during pregnancy
Study feasibility (as measured by number of participants retained in the study)
Ability to recruit and retain participants
Diabetes self-efficacy (Measured using the Perceived Diabetes Self-Management Scale)
Assessment of diabetes self-efficacy. Survey takes place after 35 weeks gestation and before discharge after delivery (postpartum day 2)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03240289
Brief Title
Texting for Diabetes Success in Pregnancy
Official Title
Use of Text Messaging to Reduce Barriers to Self-care for Low-income Pregnant Women With Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
December 2013 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Diabetes during pregnancy can be a challenging circumstance requiring extensive patient learning and self-care. The purpose of this study is to develop and pilot test a patient-centered diabetes education and self-care tool using text messaging to provide supportive messaging and education to underserved women with a pregnancy complicated by diabetes.
Detailed Description
Low-income, pregnant women in the Chicago area are frequently affected by obesity or diabetes. The addition of a disease in pregnancy amplifies the requirements for optimal self-care during pregnancy. This load of information poses a significant burden, particularly for women with additional socioeconomic barriers to self-care. Preliminary work suggests patients must overcome a number of social, psychological, and knowledge-based barriers to achieve successful diabetic control in pregnancy.
This project involves development and preliminary evaluation of a patient-centered education and self-care tool for use with women whose pregnancies are complicated by diabetes. The study begins with development of a text messaging curriculum to provide motivational and educational support. We will use a one-way, non-interactive text-based educational platform to provide supportive and educational messages to a cohort of 40 women with diabetes. Women receive 3-5 text messages per week until delivery. The goal is to develop a program that can be expanded to a clinical trial in which perinatal outcomes are assessed.
The primary outcome is patient satisfaction and opinions about the texting program, as measured via a qualitative interview upon study completion. Participants underwent an enrollment survey to assess health literacy/numeracy, diabetes self-efficacy, diabetes knowledge, personality, and social hassles. They underwent a baseline in-depth one-on-one interview focusing on barriers to successful self-care with pregnancy and diabetes. Follow-up surveys and an exit interview elicited information about their opinions of the texting program. Additional goals included determining feasibility for future expansion as a trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes, Pregnancy in Diabetics
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single arm feasibility and pilot testing study of a curriculum
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Texting
Arm Type
Other
Arm Description
Texting group
Intervention Type
Behavioral
Intervention Name(s)
Texting group
Intervention Description
Women receive text messages to aid in their diabetes self-care tasks during pregnancy; these included appointment reminders, motivational messages, and nutrition/exercise tips.
Primary Outcome Measure Information:
Title
Patient satisfaction and feedback
Description
A single qualitative interview of patient perspectives and areas for improvement in the text messaging program. Interview takes place between 35 weeks gestation and discharge after delivery (postpartum day 2)
Time Frame
Up to 42 weeks
Secondary Outcome Measure Information:
Title
Diabetes self-efficacy (Measured using the Diabetes Empowerment Scale-Short Form)
Description
Assessment of diabetes self-efficacy. Survey takes place after 35 weeks gestation and before discharge after delivery (postpartum day 2)
Time Frame
Up to 42 weeks
Title
Barriers and facilitators of diabetes self-management
Description
Qualitative interview of patient experiences regarding having diabetes during pregnancy
Time Frame
Study enrollment
Title
Study feasibility (as measured by number of participants retained in the study)
Description
Ability to recruit and retain participants
Time Frame
Up to 42 weeks
Title
Diabetes self-efficacy (Measured using the Perceived Diabetes Self-Management Scale)
Description
Assessment of diabetes self-efficacy. Survey takes place after 35 weeks gestation and before discharge after delivery (postpartum day 2)
Time Frame
Up to 42 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pregnant
English-speaking
Have gestational diabetes mellitus, type 2 diabetes mellitus, or type 1 diabetes mellitus
Age 18 years or older
Access to a phone that can receive text messages
Exclusion Criteria:
Gestational age greater than 30 weeks
Women not meeting the above inclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa A Simon, MD, MPH
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Texting for Diabetes Success in Pregnancy
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