Promoting Preconception Care and Diabetes Self-Management Among Reproductive-Aged Women With Diabetes: The PREPARED Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Northwestern University
- Enrollment
- 840
- Locations
- 1
- Primary Endpoint
- Average difference in HbA1c values between Intervention and Control Patients
- Status
- Recruiting
- Last Updated
- 5 months ago
Overview
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.
Investigators
Stacy C Bailey
Associate Professor
Northwestern University
Eligibility Criteria
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
- •severe, uncorrectable vision, hearing, or cognitive impairments that would preclude study consent or participation
Outcomes
Primary Outcomes
Average difference in HbA1c values between Intervention and Control Patients
Time Frame: 6 months
We will abstract HbA1c values from performance sites EHRs to investigate effects of PREPARED.
Knowledge of reproductive risks
Time Frame: 1 month
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.
Secondary Outcomes
- Average difference in cholesterol values between Intervention and Control Patients(6 months)
- Contraceptive use(at 1 month and 3 months)
- Average difference in blood pressure values between Intervention and Control Patients(6 months)
- Engagement in diabetes self-care activities(at 1 month and 3 months)
- Folic acid use(at 1 month and 3 months)