Optimizing Cardiovascular Preventive Care for Women Following Hypertensive Disorders of Pregnancy

Sponsor

University of Utah (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05826925

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension, Pregnancy Induced Hypertension Complicating Pregnancy Preeclampsia Cardiovascular Diseases Patient Engagement	Other: Decision aid	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Optimizing Cardiovascular Preventive Care for Women Following Hypertensive Disorders of Pregnancy

Anticipated Study Start Date :

Mar 1, 2025

Anticipated Primary Completion Date :

Aug 1, 2027

Anticipated Study Completion Date :

Aug 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Decision aid Participants will use the decision aid in the postpartum period	Other: 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.
No Intervention: Usual care Participants will receive standard postpartum care

Arm

Intervention/Treatment

Experimental: Decision aid

Participants will use the decision aid in the postpartum period

Other: 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.

No Intervention: Usual care

Participants will receive standard postpartum care

Outcome Measures

Primary Outcome Measures

Decisional conflict [6-8 weeks postpartum]
Measured via the validated Decisional Conflict Scale. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict)

Secondary Outcome Measures

Decisional conflict [One month after the initial assessment]
Measured via the validated Decisional Conflict Scale. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.