Promoting Preconception Care and Diabetes Self-Management Among Reproductive-Aged Women With Diabetes
NCT ID: NCT04976881
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
840 participants
INTERVENTIONAL
2022-05-06
2026-05-31
Brief Summary
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Detailed Description
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Aim 1: Test the effectiveness of PREPARED, compared to usual care, to improve patient: a) knowledge of reproductive risks associated with T2DM and recommended self-care activities b) engagement in self-care behaviors, including: i) diet, ii) physical activity, iii) adherence to diabetes medications; and use of iv) folic acid, and v) most or moderately effective contraception, when indicated; and c) clinical measures, including hemoglobin A1c, blood pressure, and LDL cholesterol.
Aim 2: Assess whether PREPARED reduces disparities in the above outcomes versus usual care.
Aim 3: Evaluate the fidelity of PREPARED to prompt medication reconciliation and preconception counseling, and to deliver patient education and post-visit support of diabetes self-care behaviors.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Usual Care
Usual care includes: 1) no specific materials to promote medication reconciliation, reproductive planning, or patient education on diabetes self-management within the context of preconception care, 2) variable physician preconception counseling without any EHR notifications or counseling support; and 3) no specific patient support or prompts to promote healthy behaviors post-visits.
No interventions assigned to this group
PREPARED Strategy
Our PREPARED strategy will utilize health information and consumer technologies to 'hardwire' preconception care and promote diabetes self-management among reproductive-aged, adult women with T2DM in primary care. PREPARED will leverage electronic health record technology at clinic visits to: \[1\] promote medication reconciliation and safety, \[2\] prompt provider preconception counseling, and \[3\] deliver low literacy print tools to reinforce counseling and promote diabetes self-care. Post-visit, text messaging will be used to: \[4\] encourage healthy lifestyle behaviors.
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.
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.
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.
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.
Interventions
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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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
18 Years
44 Years
FEMALE
No
Sponsors
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Northwestern Memorial Hospital
OTHER
AllianceChicago
OTHER
Northwestern University
OTHER
Responsible Party
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Stacy C Bailey
Associate Professor
Principal Investigators
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Stacy Bailey, PhD MPH
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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Northwestern University
Chicago, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Bailey SC, Pack AP, Wismer G, Calderon N, Velazquez E, Batio S, Ekong A, Eggleston A, Wallia A, Wolf MS, Schauer JM, Tenfelde S, Liebovitz DM, Grobman WA. Promoting REproductive Planning And REadiness in Diabetes (PREPARED) Study protocol: a clinic-randomised controlled trial testing a technology-based strategy to promote preconception care for women with type 2 diabetes. BMJ Open. 2023 Nov 8;13(11):e078282. doi: 10.1136/bmjopen-2023-078282.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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STU00214604
Identifier Type: -
Identifier Source: org_study_id
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