Optimizing Cardiovascular Preventive Care for Women Following Hypertensive Disorders of Pregnancy

Not Applicable

Not yet recruiting

• Conditions: Preeclampsia; Hypertension, Pregnancy Induced; Hypertension Complicating Pregnancy; Patient Engagement; Cardiovascular Diseases
• Interventions: Other: Decision aid

• Registration Number: NCT05826925
• Lead Sponsor: University of Utah

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

Study Timeline

• Study First Submitted: 2023-04-10
• Study First Submitted QC: 2023-04-10
• Study First Posted: 2023-04-24
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-21
• Study Start: 2025-06-01
• Primary Completion: 2027-08
• Study Completion: 2027-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Decision aid	Decision aid	Participants will use the decision aid in the postpartum period

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

University of Utah Hospital; 🇺🇸 Salt Lake City, Utah, United States