Health TrialsbyHealthPanel

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

ConditionsDiabetes Mellitus, Type 2Electronic Health RecordPrimary Health CareReproductive Behavior
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-44
SponsorNorthwestern University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

female

age 18-44

English or Spanish-speaking

have a chart diagnosis of type 2 diabetes

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Medication Reconciliation (MedRec) Tool

    Behavioral

    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

    Behavioral

    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

    Behavioral

    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

    Behavioral

    Within \~5 days of their index clinic visit, intervention patients will begin to receive daily, unidirectional text messages to reinforce diabetes self-care behaviors.

Treatment groups

840 Participants
are divided into 2 treatment groups
Group A: Usual CareNo intervention 0 interventions
Group B: PREPARED StrategyActive comparator 4 interventions

Trial outcomes

Primary outcomes

1

Average difference in HbA1c values between Intervention and Control Patients

We will abstract HbA1c values from performance sites EHRs to investigate effects of PREPARED.

Time frame
6 months
2

Knowledge of reproductive risks

We will use a questionnaire, developed by our team and the scientific literature, to evaluate patient knowledge of reproductive risks and recommended health behaviors for women with type 2 diabetes. It includes items assessing knowledge of pregnancy planning, reproductive risks, and desired diabetes self-care behaviors. Correctly answered questions will be summed and a total knowledge score will be generated. Higher scores indicate greater knowledge.

Time frame
1 month

Secondary outcomes

1

Average difference in blood pressure values between Intervention and Control Patients

We will abstract blood pressure values (systolic and diastolic) from performance sites EHRs to investigate effects of PREPARED.

Time frame
6 months
2

Average difference in cholesterol values between Intervention and Control Patients

We will abstract cholesterol values from performance sites EHRs to investigate effects of PREPARED.

Time frame
6 months
3

Engagement in diabetes self-care activities

We will use the validated Summary of Diabetes Self Care Activities (SDSCA) measure. Scores range from 0 to 7 for each domain, with higher scores reflect greater engagement.

Time frame
at 1 month and 3 months
4

Contraceptive use

we will use validated items to assess patient contraceptive use, which is categorized into use of a 'most or moderately effective' form of contraception or 'less effective/no contraception'

Time frame
at 1 month and 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwestern University

Lead sponsor

Northwestern Memorial Hospital

Collaborator

AllianceChicago

Collaborator

Source ClinicalTrials.gov
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