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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-touch blood pressure management | Experimental |
| |
| Low-touch blood pressure management | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-touch blood pressure management | Other | Twelve weeks of text-based home blood pressure monitoring with BP self-management and team-based care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean diastolic blood pressure (DBP) | Assessed by 24-hour ambulatory blood pressure monitor (ABPM) | 12 months postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure outcome: Mean systolic blood pressure (SBP) | Assessed by 24-hour ambulatory blood pressure monitor (ABPM) | 12 months postpartum |
| Blood pressure outcome: Mean nocturnal DBP | Assessed by ABPM |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Lewey, MD, MPH | Contact | 215-662-7700 | Jennifer.Lewey@pennmedicine.upenn.edu | |
| Alexis Giron, M.S | Contact | Alexis.Giron@Pennmedicine.upenn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jennifer Lewey, MD, MPH | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 10022 | United States |
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| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006973 | Hypertension |
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| Low-touch blood pressure management | Other | 10 days of text-based home blood pressure monitoring |
|
| 12 months postpartum |
| Blood pressure outcome: Mean nocturnal SBP | Assessed by ABPM | 12 months postpartum |
| Blood pressure outcome: Mean DBP | Assessed by home blood pressure monitor and office measurement | 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 | 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. | 12 months postpartum |
| Patient Reported Outcome - Patient Activation Measure | 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 | 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. | 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. | 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. | From 6 weeks postpartum through 1 year postpartum |
| The Ohio State University | Not yet recruiting | Columbus | Ohio | 43210 | United States |
|
| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |