Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID05995106

Prospective Validation of Heart4U App Use for Hypertensive Disorder of Pregnancy Linked to Hospital Examinations

Led by Seoul National University Hospital · Updated on 2023-12-21

580

Participants Needed

1

Research Sites

43 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of a mobile application called Heart4U to help pregnant women with hypertensive cardiovascular conditions manage their risk factors. The study aims to assess how effective this self-management approach is compared to usual care. It focuses on pregnant individuals diagnosed with hypertensive disorders of pregnancy, including chronic hypertension, gestational hypertension, preeclampsia, and superimposed preeclampsia, as well as those at elevated risk for these conditions. Participants are randomly assigned to either an app group or a usual care group. The app group receives help installing and learning to use Heart4U, which integrates with the hospital's electronic medical records. Both groups continue to receive guideline-based prenatal care and active treatment as usual. Follow-up occurs at each obstetric visit before delivery and again one month postpartum. Throughout the study, participants will have their systolic blood pressure monitored from enrollment through one month after delivery. Researchers will also track other outcomes such as blood pressure trends, obstetric results, body mass index, recorded step counts, and depression assessments. The study includes safety monitoring and aims to understand the app's role in managing hypertensive disorders during pregnancy. Participation lasts from enrollment through the postpartum follow-up period.

CONDITIONS

Brief Title

mHealth for Hypertensive Disorder of Pregnancy

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant women diagnosed with hypertensive disorders of pregnancy at or beyond 12 weeks of gestation, including chronic hypertension, gestational hypertension, preeclampsia, or superimposed preeclampsia
  • Pregnant women at elevated risk for hypertensive disorders, such as multifetal gestation, obesity, uncontrolled diabetes, history of hypertensive disorder causing preterm birth, or borderline high blood pressure during pregnancy
  • Adults aged 18 years or older who have a smartphone and can use the Heart4U mobile application independently
  • Female gender (pregnant women)
Not Eligible

You will not qualify if you...

  • Patients with delusions, confusion, or other cognitive disorders
  • Patients considered difficult to conduct the study on by researchers for various reasons
  • Individuals with very low familiarity with devices making data collection difficult
  • Pregnant patients requiring immediate electronic fetal or maternal monitoring due to imminent delivery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - From enrollment until one month postpartum

Participants either use the Heart4U mobile app with assistance from the research team or continue with guideline-based prenatal care to manage hypertensive disorders of pregnancy.

Visits as per routine prenatal care plus app usage monitoring for the app group

Trial Site Locations

Total: 1 location

1

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea, 463707

Actively Recruiting

Loading map...

Research Team

J

Jung-Won Suh, MD

H

Hye-Jin Kim, RN

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

A Multicenter Cohort Study on Maternal and Infant Microecolo...

Preeclampsia

Actively Recruiting

2 locations

A Prospective Longitudinal Observational Cohort Study of Pre...

Hypertensive Disorder of Pregnancy

Actively Recruiting

2 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Prospective validation of a mobile health application for blood pressure management in patients with hypertensive disorders of pregnancy: study protocol for a randomized controlled trial.

Ju-Seung Kwun, Jina Choi, Yeonyee E Yoon...

https://pubmed.ncbi.nlm.nih.gov/38956675