Optimizing Cardiovascular Preventive Care for Women Following Hypertensive Disorders of Pregnancy
Primary Purpose
Hypertension, Pregnancy Induced, Hypertension Complicating Pregnancy, Preeclampsia
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Decision aid
Sponsored by
About this trial
This is an interventional other trial for Hypertension, Pregnancy Induced
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.
Sites / Locations
- University of Utah Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Decision aid
Usual care
Arm Description
Participants will use the decision aid in the postpartum period
Participants will receive standard postpartum care
Outcomes
Primary Outcome Measures
Decisional conflict
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
Measured via the validated Decisional Conflict Scale. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict)
Full Information
NCT ID
NCT05826925
First Posted
April 10, 2023
Last Updated
April 10, 2023
Sponsor
University of Utah
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT05826925
Brief Title
Optimizing Cardiovascular Preventive Care for Women Following Hypertensive Disorders of Pregnancy
Official Title
Optimizing Cardiovascular Preventive Care for Women Following Hypertensive Disorders of Pregnancy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2025 (Anticipated)
Primary Completion Date
August 2027 (Anticipated)
Study Completion Date
August 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Pregnancy Induced, Hypertension Complicating Pregnancy, Preeclampsia, Cardiovascular Diseases, Patient Engagement
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Decision aid
Arm Type
Experimental
Arm Description
Participants will use the decision aid in the postpartum period
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Participants will receive standard postpartum care
Intervention Type
Other
Intervention Name(s)
Decision aid
Intervention Description
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.
Primary Outcome Measure Information:
Title
Decisional conflict
Description
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 Outcome Measure Information:
Title
Decisional conflict
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Theilen, MD
Phone
801-581-8425
Email
lauren.theilen@hsc.utah.edu
Facility Information:
Facility Name
University of Utah Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Theilen, MD
Phone
801-581-8425
Email
lauren.theilen@hsc.utah.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Optimizing Cardiovascular Preventive Care for Women Following Hypertensive Disorders of Pregnancy
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