Optimizing Cardiovascular Preventive Care for Women Following Hypertensive Disorders of Pregnancy

NCT ID: NCT05826925

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-27
• Study Completion Date: 2027-08-31

Brief Summary

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.

Detailed Description

Current evidence demonstrates that women with hypertensive disorders of pregnancy have 2-fold higher risk for the later development of cardiovascular disease (CVD) compared to women with healthy pregnancies. CVD prevention is a high priority for women's health, as it is the leading cause of death among women in the United States. In order to improve women's cardiovascular health, interventions for cardiovascular prevention could be initiated shortly after a pregnancy complicated by a hypertensive disorder. However, patient-centered interventions to promote preventive care engagement among postpartum women are lacking. Our objective is to address current gaps in knowledge regarding needs, values, and barriers regarding cardiovascular prevention among postpartum women with hypertensive disorders of pregnancy, and to remedy the lack of available evidence-based interventions for this at-risk population. To this end, we will conduct a pilot study to demonstrate feasibility and preliminary efficacy of a patient decision aid to improve patient knowledge and self-efficacy regarding CVD prevention during the postpartum period

Conditions

Hypertension, Pregnancy Induced; Hypertension Complicating Pregnancy; Preeclampsia; Cardiovascular Diseases; Patient Engagement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Decision aid

Participants will use the decision aid in the postpartum period

Group Type: EXPERIMENTAL

Decision aid

Intervention Type: OTHER

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.

Usual care

Participants will receive standard postpartum care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Decision aid

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Lauren Theilen

Assistant Professor, Obstetrics & Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Utah Hospital

Salt Lake City, Utah, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lauren Theilen, MD

Role: CONTACT

lauren.theilen@hsc.utah.edu

801-581-8425

Facility Contacts

Lauren Theilen, MD

Role: primary

lauren.theilen@hsc.utah.edu

801-581-8425

Other Identifiers

K23HL159316

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00151518

Identifier Type: -

Identifier Source: org_study_id