Mobile Health Interventions to Prevent Heart Disease After Hypertensive Disorders of Pregnancy
- Conditions
- Gestational HypertensionEclampsiaHypertension in PregnancyPre-Eclampsia
- Interventions
- Other: Remote patient monitoring (RPM) systemOther: Mobile health application
- Registration Number
- NCT06523569
- Lead Sponsor
- Northwestern University
- Brief 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).
- 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 remote patient 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 120
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bundled digital health intervention Mobile health application Participant will be enrolled in a remote patient monitoring program (Omron) and receive a subscription to a mobile health lifestyle change application (Noom) alongside usual care. Bundled digital health intervention Remote patient monitoring (RPM) system Participant will be enrolled in a remote patient monitoring program (Omron) and receive a subscription to a mobile health lifestyle change application (Noom) alongside usual care.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Participant engagement 12 months postpartum The investigators will assess participant engagement (% continuing to actively use digital health interventions) at the end of the study
Study feasibility 12 months postpartum The investigators will assess study feasibility (% enrolled in digital health intervention) 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
Trial Locations
- Locations (1)
Northwestern University, Dept. of Cardiology
🇺🇸Chicago, Illinois, United States