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

Inclusion Criteria7

  • female
  • age 18-44
  • English or Spanish-speaking
  • have a chart diagnosis of type 2 diabetes
  • not currently pregnant
  • not infecund, sterilized, or in a monogamous relationship with a sterilized partner
  • have a private cell phone with text messaging capability.

Exclusion Criteria1

  • severe, uncorrectable vision, hearing, or cognitive impairments that would preclude study consent or participation

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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