mHealth for Hypertensive Disorder of Pregnancy

NCT05995106 | Recruiting

• 1 other identifier: B-2308-844-302
• Study Type: interventional
• Target: 580
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: We have developed a cardiovascular disease management application named Heart4U, with the capability of integrating with the Electronic Medical Records (EMR) system within the hospital. The main goal of this study is to evaluate the clinical effectiveness of a treatment approach that entails self-management of risk factors through a mobile application among pregnant individuals diagnosed with hypertensive cardiovascular conditions. Methods: Patients assigned to the app group receive assistance from the research team to install the Heart4U application and familiarize themselves with its usage. Both the app group and the usual care group continue to receive active treatment as previously administered (guideline-based prenatal care). Follow-up observations occur at each obstetric examination prior to delivery and are conducted again at the first month postpartum. The primary endpoint of observation pertains to the difference in systolic blood pressure between the enrollment and study completion time points.

Conditions

Hypertensive Disorder of Pregnancy; Preeclampsia

Outcome Measures

Primary Outcomes (1)

• delta SBP

  Systolic Blood pressure (SBP) difference

  between at the time of enrollment and one month postpartum

Secondary Outcomes (5)

• Blood pressure (systolic, diastolic, mean) trajectory

  between at the time of enrollment and one month postpartum

• obstetric outcomes

  between at the time of enrollment and one month postpartum

• Body mass index (kg/m2) trajectory

  between at the time of enrollment and one month postpartum

• trajectory of the recorded step counts

  between at the time of enrollment and one month postpartum

• Depression evaluation questionnaire

  at the time of enrollment and one month postpartum

Study Arms (2)

App Group

EXPERIMENTAL

Patients assigned to the app group receive assistance from the research team to install the Heart4U application and familiarize themselves with its usage.

Other: Heart4U

Usual Care Group

NO INTERVENTION

The app (n=290) and usual care groups (n-290) continue to receive active treatment as previously administered (guideline-based prenatal care).

Interventions

Heart4U OTHER

Mobile app.

App Group

Eligibility Criteria

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

You may qualify if:

• Diagnosis: 1 or 2
• Pregnant women diagnosed with hypertensive disorders of pregnancy at or beyond 12 weeks of gestation:
• Chronic hypertension: Diagnosed with hypertension within 20 weeks of gestation (elevated office/clinic blood pressure ≥140/90 mm Hg) or currently on antihypertensive medication.
• Gestational hypertension: Newly diagnosed with hypertension after 20 weeks of gestation (elevated office/clinic blood pressure ≥140/90 mm Hg) or currently on antihypertensive medication.
• Preeclampsia: Newly diagnosed with hypertension after 20 weeks of gestation (elevated office/clinic blood pressure ≥140/90 mm Hg) or currently on antihypertensive medication, and presents with proteinuria (300 mg/24 hours or urine protein-to-creatinine ratio ≥0.3), thrombocytopenia (less than 100,000 platelets per microliter), abnormal renal function (creatinine exceeding 1.1 or doubling of baseline), elevated liver enzymes (twice normal levels), neurological symptoms (headache, visual disturbances, seizures, etc.), and/or pulmonary edema.
• Superimposed preeclampsia: Diagnosed with hypertension within 20 weeks of gestation (elevated office/clinic blood pressure ≥140/90 mm Hg) or currently on antihypertensive medication and experiences symptoms or signs related to superimposed preeclampsia.
• Pregnant women at elevated risk for hypertensive disorders of pregnancy:
• Multifetal gestation, obesity, uncontrolled gestational or pre-existing diabetes, history of hypertensive disorder of pregnancy leading to preterm birth, presence of borderline blood pressure readings during antepartum care (elevated office/clinic blood pressure ≥130/80 mm Hg) following a previous diagnosis of hypertension-related disorder in a prior pregnancy.
• , and
• Adult individuals aged 18 years and above who possess a smartphone and are capable of independently utilizing the application among pregnant women.

You may not qualify if:

• Patients with evidence of delusions, confusion, or other cognitive disorders.
• Patients deemed difficult to conduct this study on by the researchers due to various reasons.
• Cases where device familiarity is significantly low, making data collection challenging.
• Pregnant patients requiring immediate electronic fetal monitoring or maternal monitoring due to imminent delivery.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

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

RECRUITING

Related Publications (2)

• Kang SH, Baek H, Cho J, Kim S, Hwang H, Lee W, Park JJ, Yoon YE, Yoon CH, Cho YS, Youn TJ, Cho GY, Chae IH, Choi DJ, Yoo S, Suh JW. Management of cardiovascular disease using an mHealth tool: a randomized clinical trial. NPJ Digit Med. 2021 Dec 3;4(1):165. doi: 10.1038/s41746-021-00535-z.

  PMID: 34862449 BACKGROUND

• Kwun JS, Choi J, Yoon YE, Choi HM, Park JY, Kim HJ, Lee MJ, Choi BY, Yoo S, Suh JW. 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. Trials. 2024 Jul 2;25(1):435. doi: 10.1186/s13063-024-08200-y.

  PMID: 38956675 DERIVED

MeSH Terms

Conditions

Toxemia; Pre-Eclampsia

Condition Hierarchy (Ancestors)

Infections; Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Jung-Won Suh, MD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jung-Won Suh, MD

CONTACT

+821076615931; suhjw1@gmail.com

Hye-Jin Kim, RN

CONTACT

+82317877016; kimhj258@gmail.com

Study Design

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

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 16, 2023
• Study Start: October 2, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 21, 2023

Record last verified: 2023-12

Locations

KR (1)