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mHealth for Hypertensive Disorder of Pregnancy

Primary Purpose

Hypertensive Disorder of Pregnancy, Preeclampsia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Heart4U
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertensive Disorder of Pregnancy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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. 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    App Group

    Usual Care Group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    delta SBP
    Systolic Blood pressure (SBP) difference

    Secondary Outcome Measures

    Blood pressure (systolic, diastolic, mean) trajectory
    BP measured at each visit
    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)
    Body mass index (kg/m2) trajectory
    BP measured at each visit
    trajectory of the recorded step counts
    on a pedometer application within a mobile phone.
    Depression evaluation questionnaire
    Patient health questionnaires-9, Beck Depression Inventory
    Drug compliance
    MMAS scale

    Full Information

    First Posted
    August 9, 2023
    Last Updated
    August 9, 2023
    Sponsor
    Seoul National University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05995106
    Brief Title
    mHealth for Hypertensive Disorder of Pregnancy
    Official Title
    Prospective Validation of Usefulness in the Hypertensive Disorder of Pregnancy With Cardiovascular Disease Management Solution Based on Interconnection to Hospital Examination
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    August 2026 (Anticipated)
    Study Completion Date
    June 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul National University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Inclusion Criteria: 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. Adult individuals aged 18 years and above who possess a smartphone and are capable of independently utilizing the application, among pregnant women.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertensive Disorder of Pregnancy, Preeclampsia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    580 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    App Group
    Arm Type
    Experimental
    Arm Description
    Patients assigned to the app group receive assistance from the research team to install the Heart4U application and familiarize themselves with its usage.
    Arm Title
    Usual Care Group
    Arm Type
    No Intervention
    Arm Description
    The app (n=290) and usual care groups (n-290) continue to receive active treatment as previously administered (guideline-based prenatal care).
    Intervention Type
    Other
    Intervention Name(s)
    Heart4U
    Intervention Description
    Mobile app.
    Primary Outcome Measure Information:
    Title
    delta SBP
    Description
    Systolic Blood pressure (SBP) difference
    Time Frame
    between at the time of enrollment and one month postpartum
    Secondary Outcome Measure Information:
    Title
    Blood pressure (systolic, diastolic, mean) trajectory
    Description
    BP measured at each visit
    Time Frame
    between at the time of enrollment and one month postpartum
    Title
    obstetric outcomes
    Description
    (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)
    Time Frame
    between at the time of enrollment and one month postpartum
    Title
    Body mass index (kg/m2) trajectory
    Description
    BP measured at each visit
    Time Frame
    between at the time of enrollment and one month postpartum
    Title
    trajectory of the recorded step counts
    Description
    on a pedometer application within a mobile phone.
    Time Frame
    between at the time of enrollment and one month postpartum
    Title
    Depression evaluation questionnaire
    Description
    Patient health questionnaires-9, Beck Depression Inventory
    Time Frame
    at the time of enrollment and one month postpartum
    Title
    Drug compliance
    Description
    MMAS scale
    Time Frame
    at the time of enrollment and one month postpartum

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jung-Won Suh, MD
    Phone
    +821076615931
    Email
    suhjw1@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hye-Jin Kim, RN
    Phone
    +82317877016
    Email
    kimhj258@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jung-Won Suh, MD
    Organizational Affiliation
    Seoul National University Bundang Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34862449
    Citation
    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.
    Results Reference
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    mHealth for Hypertensive Disorder of Pregnancy

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