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Remote BP Monitoring in the PP Period

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ClinicalTrials.gov Identifier: NCT03728790
Recruitment Status : Not yet recruiting
First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Collaborators:
Philips Healthcare
New York Presbyterian Hospital
Information provided by (Responsible Party):
Leslie Moroz, Columbia University

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.

Condition or disease Intervention/treatment Phase
Hypertensive Disorder of Pregnancy Device: Remote Patient Monitoring Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Control Trial with 2 arms
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Remote Blood Pressure Monitoring in the Postpartum (PP) Period
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care

Arm Intervention/treatment
No Intervention: Usual Care
Usual care group patients will be assigned to the usual care given to patients with hypertensive disorders of pregnancy at Columbia University Irving Medical Center (CUIMC). This involves a prescription for a blood pressure cuff if they do not already have one, with which they will be asked to measure their blood pressure twice per day. They will be asked to keep a log of their blood pressure measurements and to bring that log to their next provider visit.
Experimental: Remote Patient Monitoring
Remote Patient Monitoring patients will use a Bluetooth-enabled blood pressure cuff, which will transmit blood pressure measurements via Bluetooth from the monitor to a tablet, which is able to be accessed by nurses staffing a remote clinical care center. Patients will also be prompted to answer surveys assessing symptoms of preeclampsia. The nurses will review measurements and survey results, which will be flagged in order of urgency. The measurements uploaded into the remote monitoring system will also be reviewed at the patient's next provider visit.
Device: Remote Patient Monitoring
Bluetooth-enabled blood pressure cuff to assess whether this technology helps providers collect more data regarding their patients' blood pressures in the postpartum period.




Primary Outcome Measures :
  1. Blood Pressure Measurement Percentage [ Time Frame: Up to 10 days from delivery ]
    Percentage of the recommended twice daily blood pressures recorded between hospital discharge and the 7-10 day postpartum blood pressure check in-person visit.


Secondary Outcome Measures :
  1. Elevated Blood Pressure Percentage [ Time Frame: Up to 10 days from delivery ]
    Percentage of recorded blood pressure values in 7-10 days postpartum that are elevated (>140 systolic OR >90 diastolic)

  2. Percentage of Elevated Blood Pressure Leading to Conversation between Patient and Provider [ Time Frame: Up to 10 days from delivery ]
    Percentage of elevated blood pressures that triggered a phone call or conversation with an obstetric provider

  3. Visit Compliance Rate [ Time Frame: Up to 10 days from delivery ]
    Rate of attendance at 7-10 day blood pressure check visit

  4. Incidence of BP Elevations [ Time Frame: Up to 10 days from delivery ]
    Incidence of elevated blood pressure at the 7-10 day blood pressure check visit

  5. Visit Compliance Rate [ Time Frame: 6 weeks from delivery ]
    Rate of attendance at 6 week postpartum visit

  6. Incidence of BP Elevations [ Time Frame: 6 weeks from delivery ]
    Incidence of elevated blood pressure (BP) at the 6-week postpartum visit

  7. Time to Medication Initiation [ Time Frame: 6 weeks from delivery ]
    Time to initiation of antihypertensive medications (in patients who were not on medications at time of discharge)

  8. Final Antihypertensive Dosage [ Time Frame: 6 weeks from delivery ]
    Final dosage of antihypertensive medications at 6 weeks postpartum

  9. Readmission Rate [ Time Frame: 6 weeks from delivery ]
    Rate of readmission in the postpartum period

  10. ED Visit Rate [ Time Frame: 6 weeks from delivery ]
    Rate of emergency department (ED) visits

  11. Rate of Morbidity [ Time Frame: 6 weeks from delivery ]
    Incidence of hypertension-related morbidities (eg: stroke, seizure, PRES)

  12. Percentage with Primary Care Referrals [ Time Frame: 6 weeks from delivery ]
    Percentage of patients who require a referral to primary care physicians after being discharged from obstetric care at the 6-week postpartum visit

  13. Score on the Modified Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ) [ Time Frame: 6 weeks from delivery ]
    The modified TSUQ is an 18-item survey that will be used to measure patient satisfaction with remote blood pressure monitoring. Individuals score each of the items based on their satisfaction, with 1=strongly disagree to 5=strongly agree. The responses would then be used to calculate a mean score on the 5-point scale, with 5 indicating the most satisfaction.

  14. Change in Score on the Philips Program Survey [ Time Frame: 6 weeks from delivery ]
    The Philips program start survey is a 4 question survey to gauge how patients relate to their care and their doctors prior to initiation of their blood pressure monitoring program. Individuals score each of the items based on the perception of their care, with 5 being best and 1 being worst. The responses would then be used to calculate a mean score on the 5-point scale, with 5 indicating the most satisfaction, and compared between the 2 groups. The Philips program end survey is a 6 question survey to gauge how patients related to their care and their doctors after the completion of their blood pressure monitoring program. Individuals score each of the items based on the perception of their care, with 5 being best and 1 being worst. The responses would then be used to calculate a mean score on the 5-point scale, with 5 indicating the most satisfaction, and compared between the 2 groups.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postpartum women
  • 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 remain hospitalized (as part of their delivery hospitalization) at 7 days postpartum
  • Women who are physically unable to hold or use the tablet
  • Women who do not have a working phone

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03728790


Contacts
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Contact: Jessica Spiegelman, MD 646-992-0944 js5129@cumc.columbia.edu

Locations
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United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Philips Healthcare
New York Presbyterian Hospital
Investigators
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Principal Investigator: Leslie Moroz, MD Columbia University

Publications:

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Responsible Party: Leslie Moroz, Assistant Professor of Obstetrics & Gynecology, Columbia University
ClinicalTrials.gov Identifier: NCT03728790     History of Changes
Other Study ID Numbers: AAAS0065
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Leslie Moroz, Columbia University:
hypertensive disorders of pregnancy
preeclampsia
gestational hypertension
HELLP

Additional relevant MeSH terms:
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Hypertension
Pregnancy Complications
Toxemia
Pre-Eclampsia
Vascular Diseases
Cardiovascular Diseases
Infection
Hypertension, Pregnancy-Induced