Clinical trial NCT03728790: Remote BP Monitoring in the PP Period
Official title: A Remote Postpartum (PP) Blood Pressure Surveillance and Reminder System for Hypertensive Disorders of Pregnancy: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertensive Disorder of Pregnancy
Keywords: hypertensive disorders of pregnancy
preeclampsia
gestational hypertension
HELLP
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Philips Healthcare
name: New York Presbyterian Hospital
First posted: 2018-11-02
Enrollment: 213
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial with 2 arms
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to trial remote patient monitoring (RPM) in the postpartum hypertensive population in a randomized control design, with an aim to increase the number of blood pressure measurements taken during the fragile and under-monitored postpartum period and to thereby improve postpartum blood pressure control and reduce severe morbidity and mortality. The investigators plan to compare the number of blood pressures recorded in the first 10 days postpartum between patients who have been enrolled in an RPM trial to those who are being treated with the usual care.

Detailed description: Many women develop high blood pressure as a complication of pregnancy. This high blood pressure can often take many weeks to resolve, and for some women it never resolves completely. If untreated, high blood pressure of pregnancy can lead to serious consequences, such as seizure or stroke. Unfortunately, because most women are sent home from the hospital just 2-3 days after having a baby, the best way of monitoring blood pressure at home is still unknown. Most women are given a prescription for a blood pressure cuff to use at home and an appointment to see their doctor at about one week after delivery to review their blood pressures, but many women have trouble checking their blood pressures, sometimes because they have a new baby at home and sometimes for other reasons like transportation or difficult social situations. Using a Bluetooth blood pressure monitoring system might help women have better blood pressure monitoring after they are discharged from the hospital after delivery, and therefore help to prevent some of the complications that can happen because of high blood pressure related to pregnancy.

Eligibility criteria: Inclusion Criteria:

* Postpartum women
* Previous diagnosis of chronic hypertension, or antepartum diagnosis of hypertensive disorder of pregnancy (defined as documented blood pressure of ≥140 systolic or ≥90 diastolic on at least 2 occasions at least 4 hours apart)
* At least 18 years of age
* English or Spanish speakers

Exclusion Criteria:

* Non-English or Spanish speakers
* Women who are not planning on obtaining their postpartum follow up at CUIMC
* Women who are physically unable to hold or use the tablet
* Women who do not have a working phone
* Provider unwilling or unable to set up escalation pathway
* Women who reside outside of New York State
* Hypertension diagnosed postpartum

Primary outcomes:
measure: Blood Pressure (BP) Surveillance Adherence
timeFrame: Up to 14 days from delivery hospitalization discharge
Secondary outcomes:
measure: Total Percentage of Elevated Blood Pressure Readings
timeFrame: Up to 14 days from delivery hospitalization discharge
measure: Number of Participants With Outpatient BP Assessment Within 14 Days
timeFrame: Up to 14 days from delivery hospitalization discharge
measure: Percentage of Participants With Elevated BP After Discharge
timeFrame: Up to 14 days from delivery hospitalization discharge
measure: Number of Participants With Outpatient PP Assessment
timeFrame: Up to 8 weeks from delivery
measure: Percentage of Participants With Elevated Blood Pressure at the Postpartum Visit
timeFrame: Up to 8 weeks from delivery
measure: Time to Medication Initiation
timeFrame: Up to 8 weeks from delivery
measure: Number of Participants Initiated on Antihypertensive Therapy After Hospital Discharge
timeFrame: Up to 8 weeks from delivery
measure: Number of Participants Readmitted
timeFrame: Up to 8 weeks from delivery
measure: Number of Participants With ED Visit
timeFrame: Up to 8 weeks from delivery
measure: Number of Participants Who Developed Preeclampsia-associated Complications
timeFrame: Up to 8 weeks from delivery
measure: Number of Participants Referred to Primary Care for Continued Blood Pressure Management
timeFrame: Up to 8 weeks from delivery
measure: Score on the Modified Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ)
timeFrame: Up to 8 weeks from delivery
measure: Score on the Philips Program Start Survey and the Philips Program End Survey
timeFrame: Baseline, program end (up to 8 weeks from delivery)
measure: Communications
timeFrame: Up to 14 days post delivery hospitalization discharge
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Leslie Moroz, MD
role: PRINCIPAL_INVESTIGATOR
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