RecruitingNot ApplicableNCT04976881

Promoting Preconception Care and Diabetes Self-Management Among Reproductive-Aged Women With Diabetes

Promoting Preconception Care and Diabetes Self-Management Among Reproductive-Aged Women With Diabetes: The PREPARED Trial


Sponsor

Northwestern University

Enrollment

840 participants

Start Date

May 6, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 44 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a text message-based health program to help women of reproductive age who have type 2 diabetes better manage their condition and prepare for a healthy pregnancy. Researchers want to see if this kind of digital support can improve diabetes control and awareness of preconception care. **You may be eligible if...** - You are a woman between 18 and 44 years old - You speak English or Spanish - You have a diagnosis of type 2 diabetes - You are not currently pregnant - You can still become pregnant (not sterilized) - You have a cell phone with text messaging **You may NOT be eligible if...** - You have severe vision, hearing, or cognitive impairments that would prevent you from participating Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALMedication 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.

BEHAVIORALProvider 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.

BEHAVIORALPREPSheet

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.

BEHAVIORALText 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.


Locations(1)

Northwestern University

Chicago, Illinois, United States

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NCT04976881


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