mHealth for Hypertensive Disorder of Pregnancy

Prospective Validation of Usefulness in the Hypertensive Disorder of Pregnancy With Cardiovascular Disease Management Solution Based on Interconnection to Hospital Examination

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.

Study Overview

• Status: Recruiting
• Conditions: Preeclampsia; Hypertensive Disorder of Pregnancy
• Intervention / Treatment: Other: Heart4U

Detailed Description

Inclusion Criteria:

• Diagnosis: 1 or 2

  1. 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.

  2. 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.

• Adult individuals aged 18 years and above who possess a smartphone and are capable of independently utilizing the application, among pregnant women.

• Study Type: Interventional
• Enrollment (Estimated): 580
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jung-Won Suh, MD; Phone Number: +821076615931; Email: suhjw1@gmail.com
• Study Contact Backup: Name: Hye-Jin Kim, RN; Phone Number: +82317877016; Email: kimhj258@gmail.com

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam, Gyeonggi-do, Korea, Republic of, 463707
      • Recruiting
      • Seoul National University Bundang Hospital
      • Contact: Jung-Won Suh; Phone Number: 82-31-787-7016; Email: suhjw1@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis: 1 or 2

  1. 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.

  2. 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: App Group; 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; Mobile app.
No Intervention: Usual Care Group; The app (n=290) and usual care groups (n-290) continue to receive active treatment as previously administered (guideline-based prenatal care).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
delta SBP	Systolic Blood pressure (SBP) difference	between at the time of enrollment and one month postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure (systolic, diastolic, mean) trajectory	BP measured at each visit	between at the time of enrollment and one month postpartum
obstetric outcomes	(The use of antihypertensive medication, progression to eclampsia or preeclampsia, pulmonary edema, fetal growth restriction, oligohydramnios, premature placental abruption, preterm birth (delivery between 20 and less than 37 weeks of gestation)	between at the time of enrollment and one month postpartum
Body mass index (kg/m2) trajectory	BP measured at each visit	between at the time of enrollment and one month postpartum
trajectory of the recorded step counts	on a pedometer application within a mobile phone.	between at the time of enrollment and one month postpartum
Depression evaluation questionnaire	Patient health questionnaires-9, Beck Depression Inventory	at the time of enrollment and one month postpartum

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Jung-Won Suh, MD, Seoul National University Bundang Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: August 9, 2023
• First Submitted That Met QC Criteria: August 9, 2023
• First Posted (Actual): August 16, 2023

Study Record Updates

• Last Update Posted (Estimated): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Infections; Hypertension, Pregnancy-Induced; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Toxemia; Hypertension; Pre-Eclampsia; Pregnancy Complications
• Other Study ID Numbers: B-2308-844-302

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No