Clinical trial NCT04976881: Promoting Preconception Care and Diabetes Self-Management Among Reproductive-Aged Women With Diabetes
Official title: Promoting Preconception Care and Diabetes Self-Management Among Reproductive-Aged Women With Diabetes: The PREPARED Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Electronic Health Record
Primary Health Care
Reproductive Behavior
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Northwestern Memorial Hospital
name: AllianceChicago
First posted: 2021-07-26
Enrollment: 840
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: Our Promoting REproductive Planning, And REadiness in Diabetes (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. Specifically, PREPARED will leverage electronic health record (EHR) technology at clinic visits to: \[1\] promote medication reconciliation and safety, \[2\] prompt patient-provider preconception counseling and reproductive planning, and \[3\] deliver low literacy print tools to reinforce counseling and promote goal-setting for diabetes self-care activities. Post-visit, a widely-available text messaging platforms will be used to: \[4\] encourage healthy lifestyle behaviors through goal-setting and daily reminders. Our randomized trial will assess the effectiveness and fidelity of a technology-based strategy to promote preconception care and diabetes self-management among women with type 2 diabetes in primary care.

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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

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

Primary outcomes:
measure: Average difference in HbA1c values between Intervention and Control Patients
timeFrame: 6 months
measure: Knowledge of reproductive risks
timeFrame: 1 month
Secondary outcomes:
measure: Average difference in blood pressure values between Intervention and Control Patients
timeFrame: 6 months
measure: Average difference in cholesterol values between Intervention and Control Patients
timeFrame: 6 months
measure: Engagement in diabetes self-care activities
timeFrame: at 1 month and 3 months
measure: Contraceptive use
timeFrame: at 1 month and 3 months
measure: Folic acid use
timeFrame: at 1 month and 3 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Stacy Bailey, PhD MPH
role: PRINCIPAL_INVESTIGATOR
References: