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

NCT06523569 — Not applicable, Active not recruiting, 120 participants, Northwestern University

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RegistryNCT06523569, acronym mHEART
StatusActive not recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, prevention
Enrollment120 (Estimated)
SponsorNorthwestern University (Other); collaborators: Friends of Prentice, Senior Faculty Academy
ConditionsHypertension in Pregnancy, Pre-Eclampsia, Eclampsia, Gestational Hypertension
InterventionsDigital Blood Pressure Monitoring System, Mobile health application (Other)
Datesstart 2024-11-07, primary completion 2026-12-01 (estimated), completion 2026-12-01 (estimated), first posted 2024-07-26, last updated 2026-06-08
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Hypertension in Pregnancy All trials for Pre-Eclampsia All trials of Digital Blood Pressure Monitoring System All trials of Mobile health application

-Summary

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).

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+Detailed description

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.

+Arms and interventions

ArmTypeInterventionsDescription
Usual Care (Control)No interventionParticipant will receive usual care.
Bundled digital health interventionExperimentalOther: Digital Blood Pressure Monitoring System; Other: Mobile health applicationParticipant 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.
  • Digital Blood Pressure Monitoring System (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 (Other): As a part of the bundled digital health intervention, the participant will be given a lifestyle change mobile health application.

+Outcome measures

Primary outcomes

  • Systolic blood pressure [3 months postpartum; 12 months postpartum]: All participants will have systolic blood pressure measured at 3 months and 12 months postpartum

Secondary outcomes

  • Weight [3 months postpartum; 12 months postpartum]: All participants will have weight measured at 3 months and 12 months postpartum
  • Subclinical cardiovascular dysfunction via echocardiography [3 months postpartum; 12 months postpartum]: All participants will have echocardiography performed at 3 months and 12 months postpartum to assess subclinical cardiovascular dysfunction
  • Study feasibility [12 months postpartum]: The investigators will assess study feasibility (% enrolled in digital health intervention) at the end of the study
  • Participant engagement [12 months postpartum]: The investigators will assess participant engagement (% continuing to actively use digital health interventions) at the end of the study
  • Anti-hypertensive medication use (%) [3 months postpartum; 12 months postpartum]: The investigators will assess participant anti-hypertensive medication use (%) at 3 months and 12 months

+Eligibility

Sex: Female, ages: 18 Years to 99 Years

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

+Locations (1)

FacilityCityCountryStatus
Northwestern University, Dept. of CardiologyChicago, IllinoisUnited States

+Investigators