Mobile Health Interventions to Prevent Heart Disease After Hypertensive Disorders of Pregnancy

NCT ID: NCT06523569

Last Updated: 2025-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-07

Study Completion Date

2026-06-30

Brief Summary

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The purpose of this research is to study digital health interventions to prevent cardiovascular disease in individuals who have had a hypertensive disorder of pregnancy (HDP).

Detailed Description

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The purpose of this research is to test the effect of two digital health interventions on cardiovascular health and subclinical cardiac dysfunction in postpartum individuals after pregnancies complicated by new-onset hypertensive disorder of pregnancy (HDP). All participants will undergo echocardiography and have their blood pressure/weight captured at 3 months and 12 months postpartum. If randomized to the intervention arm, the participant will be given a subscription to a mobile health application and a digital blood pressure monitoring system, and asked to utilize these at home during the one year of the study along with usual care. If randomized to the control arm, the participant will receive care as usual.

Conditions

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Hypertension in Pregnancy Pre-Eclampsia Eclampsia Gestational Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Usual Care (Control)

Participant will receive usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Bundled digital health intervention

Participant will be enrolled in a digital blood pressure monitoring program and receive a subscription to a mobile health lifestyle change application (Noom) alongside usual care.

Group Type EXPERIMENTAL

Digital Blood Pressure Monitoring System

Intervention Type OTHER

As a part of the bundled digital health intervention, the participant will receive instructions on how to follow a link in their electronic patient portal that will allow direct input of home blood pressure readings for clinical review.

Mobile health application

Intervention Type OTHER

As a part of the bundled digital health intervention, the participant will be given a lifestyle change mobile health application.

Interventions

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Digital Blood Pressure Monitoring System

As a part of the bundled digital health intervention, the participant will receive instructions on how to follow a link in their electronic patient portal that will allow direct input of home blood pressure readings for clinical review.

Intervention Type OTHER

Mobile health application

As a part of the bundled digital health intervention, the participant will be given a lifestyle change mobile health application.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Delivery at Northwestern Memorial Hospital (Prentice Women's Hospital)
* Live birth at any gestational age
* Pregnancy complicated by new-onset HDP (pre-eclampsia, eclampsia, or gestational hypertension)

Exclusion Criteria

* HELLP syndrome
* History of chronic diseases pre-pregnancy (hypertension, diabetes, cardiovascular disease, chronic renal disease)
* Current Omron remote patient monitoring or Noom user
* BMI\<18.5 kg/m2 at enrollment
* Inadequate gestational weight gain or gestational weight loss
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Friends of Prentice

OTHER

Sponsor Role collaborator

Senior Faculty Academy

UNKNOWN

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Priya Freaney

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Priya M Freaney, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University, Dept. of Cardiology

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Priya M Freaney, MD

Role: CONTACT

(312) 664-3278

Facility Contacts

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Kathleen Flores

Role: primary

312-503-1069

Other Identifiers

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STU00219095

Identifier Type: -

Identifier Source: org_study_id

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