Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Inclusion Criteria:
Diagnosis: 1 or 2
Pregnant women diagnosed with hypertensive disorders of pregnancy at or beyond 12 weeks of gestation:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heart4U | Other | Mobile app. |
|
| Measure | Description | Time Frame |
|---|---|---|
| delta SBP | Systolic Blood pressure (SBP) difference | between at the time of enrollment and one month postpartum |
| 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) |
Not provided
Inclusion Criteria:
Diagnosis: 1 or 2
Pregnant women diagnosed with hypertensive disorders of pregnancy at or beyond 12 weeks of gestation:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jung-Won Suh, MD | Contact | +821076615931 | suhjw1@gmail.com | |
| Hye-Jin Kim, RN | Contact | +82317877016 | kimhj258@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jung-Won Suh, MD | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | Gyeonggi-do | 463707 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34862449 | Background | 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. | |
| 38956675 | Derived |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014115 | Toxemia |
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D007239 | Infections |
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| 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. |
| D000091642 | Urogenital Diseases |