Clinical trial NCT03240289: 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
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Pregnancy in Diabetics
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2017-08-07
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm feasibility and pilot testing study of a curriculum
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Patient satisfaction and feedback
timeFrame: Up to 42 weeks
Secondary outcomes:
measure: Diabetes self-efficacy (Measured using the Diabetes Empowerment Scale-Short Form)
timeFrame: Up to 42 weeks
measure: Barriers and facilitators of diabetes self-management
timeFrame: Study enrollment
measure: Study feasibility (as measured by number of participants retained in the study)
timeFrame: Up to 42 weeks
measure: Diabetes self-efficacy (Measured using the Perceived Diabetes Self-Management Scale)
timeFrame: Up to 42 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Northwestern University
name: Melissa A Simon, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: