Optimizing Cardiovascular Preventive Care for Women Following Hypertensive Disorders of Pregnancy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Utah

About this trial

Cardiovascular disease is the leading cause of death among women in the United States, and women with hypertensive disorders of pregnancy have a 2-fold higher risk for cardiovascular disease later in life compared to women with uncomplicated pregnancies. This research investigates a patient-centered intervention during the postpartum period to promote engagement in cardiovascular preventive care.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Delivered a pregnancy complicated by a hypertensive disorder of pregnancy at the University of Utah during the current hospital admission

Ability to speak and read English or Spanish

Written informed consent obtained

Disqualifiers

Cardiovascular disease diagnosis (history of peripheral artery disease, stroke, or myocardial infarction)

Impairment of cognitive function or vision that prohibits communication and/or reading the decision aid.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Decision aid

    Other intervention

    A decision aid will be developed based on qualitative data from Aim 1 and iterative refinement with input from stakeholders from Aim 2. Anticipated content includes: 1) information about cardiovascular risk following hypertensive disorders of pregnancy; 2) goal-setting exercises for blood pressure, weight management, glucose control, physical activity, and smoking cessation; 3) self-care steps to achieve management targets; 4) values clarification exercises to identify values related to cardiovascular risk management and identify priority areas for focus and improvement; and 5) discussion of how to communicate questions and goals of treatment to their provider.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Decision aidExperimental treatment 1 intervention
Group B: Usual careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Decisional conflict

Measured via the validated Decisional Conflict Scale. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict)

Time frame
6-8 weeks postpartum

Secondary outcomes

1

Decisional conflict

Measured via the validated Decisional Conflict Scale. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict)

Time frame
One month after the initial assessment

Other outcomes

Sponsors and contacts

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University of Utah

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator