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

No results posted yet for this study

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
  • Northwestern University

    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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04976881 on ClinicalTrials.gov