search
Back to results

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
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Gestational Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    July 14, 2017
    Last Updated
    August 1, 2017
    Sponsor
    Northwestern University
    search

    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

    Learn more about this trial

    Texting for Diabetes Success in Pregnancy

    We'll reach out to this number within 24 hrs