Hypertension in Pregnancy, Pre-Eclampsia, Eclampsia, Gestational Hypertension
Conditions
Keywords
digital health, echocardiogram, blood pressure
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 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.
Interventions
OTHERDigital 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.
As a part of the bundled digital health intervention, the participant will be given a lifestyle change mobile health application.
Sponsors
Friends of Prentice
Senior Faculty Academy
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactPriya M Freaney, MD
Outcome results
None listed