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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
770
Twelve weeks of text-based home blood pressure monitoring with BP self-management and team-based care
10 days of text-based home blood pressure monitoring
NYU Langone Health
New York, New York, United States
RECRUITINGThe Ohio State University
Columbus, Ohio, United States
NOT_YET_RECRUITINGUniversity of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGMean diastolic blood pressure (DBP)
Assessed by 24-hour ambulatory blood pressure monitor (ABPM)
Time frame: 12 months postpartum
Blood pressure outcome: Mean systolic blood pressure (SBP)
Assessed by 24-hour ambulatory blood pressure monitor (ABPM)
Time frame: 12 months postpartum
Blood pressure outcome: Mean nocturnal DBP
Assessed by ABPM
Time frame: 12 months postpartum
Blood pressure outcome: Mean nocturnal SBP
Assessed by ABPM
Time frame: 12 months postpartum
Blood pressure outcome: Mean DBP
Assessed by home blood pressure monitor and office measurement
Time frame: 12 months postpartum
Chronic Hypertension
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
Time frame: 12 months postpartum
Echocardiogram Outcomes
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.
Time frame: 12 months postpartum
Patient Reported Outcome - Patient Activation Measure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Time frame: Post-randomization to 1 year postpartum
Patient Reported Outcome - Perceived Stress
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.
Time frame: Post-randomization to 1 year postpartum
Patient Reported Outcome - Self-Efficacy
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.
Time frame: Post randomization to 1 year postpartum
Implementation Outcome: Acceptability of Intervention
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.
Time frame: From 6 weeks postpartum through 1 year postpartum