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Randomized Controlled Trial of Two Mobile Health Strategies to Manage Postpartum Hypertension (SMART BP)

J

Jennifer Lewey, MD, MPH

Status

Not yet enrolling

Conditions

Hypertension, Pregnancy Induced

Treatments

Other: Low-touch blood pressure management
Other: High-touch blood pressure management

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

A multicenter randomized trial that will compare the effectiveness of two postpartum blood pressure (BP) management strategies in improving blood pressure and cardiac function and increasing patient engagement and feeling of control over one's health

Enrollment

770 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age ≥18 years
  • Delivery within 14 days
  • Diagnosis of preeclampsia or gestational hypertension with or without severe features during pregnancy or within 14 days postpartum
  • Initiation of blood pressure medication prior to hospital discharge and up to 14 days postpartum
  • English or Spanish speaking (able to read/understand consent and instructions)
  • Has phone texting capabilities

Exclusion criteria

  • Diagnosis of chronic hypertension prior to delivery (would therefore include super imposed preeclampsia)
  • Pre-existing cardiovascular disease (including prior myocardial infarction, stroke, heart failure with reduced ejection fraction, ventricular tachycardia, prior cardiac arrest, pacemaker, severe valvular heart disease, or prior cardiac surgery)
  • Chronic kidney disease (stage 3 or higher)
  • Using ≥3 BP medications at time of enrollment

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

770 participants in 2 patient groups

High-touch blood pressure management
Experimental group
Treatment:
Other: High-touch blood pressure management
Low-touch blood pressure management
Experimental group
Treatment:
Other: Low-touch blood pressure management

Trial contacts and locations

3

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Central trial contact

Jennifer Lewey, MD, MPH; Alexis Giron, M.S

Data sourced from clinicaltrials.gov

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