Promoting Preconception Care and Diabetes Self-Management Among Reproductive-Aged Women With Diabetes
NCT04976881 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 840
Last updated 2025-11-18
Summary
This study is being done to investigate strategies that may improve patient's knowledge of type 2 diabetes during reproductive age and improve knowledge and engagement in self-care activities.
Conditions
- Diabetes Mellitus, Type 2
- Electronic Health Record
- Primary Health Care
- Reproductive Behavior
Interventions
- BEHAVIORAL
-
Medication Reconciliation (MedRec) Tool
Patients will receive a print MedRec tool, generated via the EHR, which includes a list of medications prescribed according to the patient record. Patients are asked to review this list, to add/remove drugs to reflect actual use, to note how they are taking each medication, and to describe any concerns.
- BEHAVIORAL
-
Provider Alert and Decision Support
During the clinic visit, an automated, EHR alert will notify the provider that the patient is a woman of reproductive age with T2DM and should receive counseling on the importance of glycemic control, the use of contraception until glycemic control is achieved, and the benefits of folic acid.
- BEHAVIORAL
-
PREPSheet
When patients leave an encounter, they will receive a patient-friendly educational material (a.k.a. the PREPSheet) that reviews potential risks of pregnancy in the context of T2DM and highlights the importance of: 1) achieving glycemic control through diabetes self-care, 2) using effective contraception until glycemic control is achieved and pregnancy is desired, 3) discussing medication use with a provider if planning or becoming pregnant, and 4) taking folic acid daily to reduce increased risk of neural tube defects.
- BEHAVIORAL
-
Text Messaging
Within \~5 days of their index clinic visit, intervention patients will begin to receive daily, unidirectional text messages to reinforce diabetes self-care behaviors.
Sponsors & Collaborators
-
Northwestern Memorial Hospital
collaborator OTHER -
AllianceChicago
collaborator OTHER - lead OTHER
Principal Investigators
-
Stacy Bailey, PhD MPH · Northwestern University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 44 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-05-06
- Primary Completion
- 2026-05-31
- Completion
- 2026-05-31
Countries
- United States
Study Locations
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