Better Understanding Patient Perspectives of an Educational Tool for Postpartum Hypertensive Patients

NCT06996496 | Active Not Recruiting

• 2 other identifiers: 2024P000730GR0127667
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if an educational tool helps postpartum patients after having high blood pressure during their pregnancy. The main question it aims to answer is: Does receiving this educational tool improve patient activation in the postpartum period? Researchers will compare a group of postpartum patients who get the tool 0-2 weeks after delivery with patients who do not get the tool to see if there is a difference in their activation scores 4-12 weeks later. Participants will: Complete a survey at first contact with study staff Complete a similar follow-up survey 4-12 weeks later

Conditions

Hypertension, Pregnancy Induced

Keywords

hypertension, pregnancy induced; patient satisfaction; maternal health; postpartum period; cardiovascular diseases; hypertension

Outcome Measures

Primary Outcomes (1)

• patient activation measure

  Patient Activation Measure (PAM)-13 questionnaire. Range is 0-100, with higher scores representing higher patient activation.

  From enrollment to 4-12 weeks after initial contact

Study Arms (2)

Postpartum patients after hypertensive disorders of pregnancy exposed to an educational tool

EXPERIMENTAL

Postpartum patients after hypertensive disorders of pregnancy exposed to an educational tool

Other: Postpartum educational tool after hypertensive pregnancy

Postpartum patients after hypertensive disorders of pregnancy not exposed to an educational tool

NO INTERVENTION

Postpartum patients after hypertensive disorders of pregnancy not exposed to an educational tool

Interventions

Postpartum educational tool after hypertensive pregnancy OTHER

postpartum educational tool for patients having experienced a hypertensive disorder of pregnancy

Postpartum patients after hypertensive disorders of pregnancy exposed to an educational tool

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical diagnosis of a hypertensive disorder of pregnancy, defined as having blood pressure reading greater than 130/80
• be postpartum
• or older at the time of enrollment
• able to speak, read, and understand English or Spanish.

You may not qualify if:

• no clinical diagnosis of hypertension before, during, or after their pregnancy defined as having blood pressure reading greater than 130/80
• under the age of 18
• only able to speak and read in a language other than English or Spanish
• unable to legally consent to participate

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• CVS Health Foundation: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Links

• link to educational tool being studied

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Patient Satisfaction; Cardiovascular Diseases; Hypertension

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Ann Celi, MD, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Physician

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: May 30, 2025
• Study Start: September 18, 2024
• Primary Completion: September 2, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)