| Registry | NCT06523569, acronym mHEART |
|---|---|
| Status | Active not recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, prevention |
| Enrollment | 120 (Estimated) |
| Sponsor | Northwestern University (Other); collaborators: Friends of Prentice, Senior Faculty Academy |
| Conditions | Hypertension in Pregnancy, Pre-Eclampsia, Eclampsia, Gestational Hypertension |
| Interventions | Digital Blood Pressure Monitoring System, Mobile health application (Other) |
| Dates | start 2024-11-07, primary completion 2026-12-01 (estimated), completion 2026-12-01 (estimated), first posted 2024-07-26, last updated 2026-06-08 |
| Locations | 1 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
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).
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Usual Care (Control) | No intervention | Participant will receive usual care. | |
| Bundled digital health intervention | Experimental | Other: Digital Blood Pressure Monitoring System; Other: Mobile health application | 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. |
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
| Facility | City | Country | Status |
|---|---|---|---|
| Northwestern University, Dept. of Cardiology | Chicago, Illinois | United States |