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NCT Number: NCT07209254

Randomized Controlled Trial of Two Mobile Health Strategies to Manage Postpartum Hypertension

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

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Key information

Conditions

Hypertension, Pregnancy Induced Cardiovascular Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health, New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-touch blood pressure management

Other

Twelve weeks of text-based home blood pressure monitoring with BP self-management and team-based care

Low-touch blood pressure management

Other

10 days of text-based home blood pressure monitoring

Primary outcomes

  1. Mean diastolic blood pressure (DBP)

    Time frame: 12 months postpartum

    Assessed by 24-hour ambulatory blood pressure monitor (ABPM)

Secondary outcomes

  1. Blood pressure outcome: Mean systolic blood pressure (SBP)

    Time frame: 12 months postpartum

    Assessed by 24-hour ambulatory blood pressure monitor (ABPM)

  2. Blood pressure outcome: Mean nocturnal DBP

    Time frame: 12 months postpartum

    Assessed by ABPM

  3. Blood pressure outcome: Mean nocturnal SBP

    Time frame: 12 months postpartum

    Assessed by ABPM

  4. Blood pressure outcome: Mean DBP

    Time frame: 12 months postpartum

    Assessed by home blood pressure monitor and office measurement

  5. Chronic Hypertension

    Time frame: 12 months postpartum

    Defined as 24-hour mean systolic blood pressure greater than or equal to 12mmHg, mean diastolic blood pressure greater than or equal to 75mmHg as assessed by ABPM or taking BP medication

  6. Echocardiogram Outcomes

    Time frame: 12 months postpartum

    Patients will all undergo a routine transthoracic echocardiogram. Measurements include: Left ventricle (LV) mass index, Relative wall thickness, mean E/e' ratio, left atrial (LA) volume index, global longitudinal strain.

  7. Patient Reported Outcome - Patient Activation Measure

    Time frame: Post-randomization to 1 year postpartum

    Patient Activation Measure (PAM) is a 10 survey that assesses an individual's knowledge, skills and confidence integral to managing one's own health and healthcare. Scored on a scale from 0-100 that correlates to one of four levels of patient activation. PAM Levels 1 and 2 indicate lower patient activation, while PAM Levels 3 and 4 indicate higher patient activation.

    Survey will be completed at 3 timepoints: at randomization, 6-10 weeks postpartum, and 12 months postpartum

  8. Patient Reported Outcome - Perceived Stress

    Time frame: Post-randomization to 1 year postpartum

    Scores from the validated Perceived Stress Scale (PSS-10) will be calculated using standard scoring criteria for each of the 10 items. Higher scores are correlated with more perceived stress.

    Survey to be completed at randomization, at 6-10 weeks postpartum, and at 1 year postpartum.

  9. Patient Reported Outcome - Self-Efficacy

    Time frame: Post randomization to 1 year postpartum

    New General Self-Efficacy Scale is an 8-item measure that assesses how much people believe they can achieve their goals, despite difficulties. Using a 5-point rating scale where 1=strongly disagree and 5=strongly agree, scores are calculated by taking the average of their ratings. Survey to be completed at randomization, at 6-10 weeks postpartum, and at 1 year postpartum.

  10. Implementation Outcome: Acceptability of Intervention

    Time frame: From 6 weeks postpartum through 1 year postpartum

    Patients will be asked questions to assess the acceptability of the intervention. The questions will be scored on a Likert response scales from 1 to 5. Higher scores represent higher acceptability. Asked at two time points, 6 weeks and 12 months postpartum.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexis Giron, M.S

CONTACT

[email protected]

Jennifer Lewey, MD, MPH

CONTACT

[email protected]

215-662-7700

Sponsors and collaborators

Lead sponsor

Jennifer Lewey, MD, MPH

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Acronym: SMART BP

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Oct 6, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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