- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03728790
Remote BP Monitoring in the PP Period
September 5, 2020 updated by: Leslie Moroz, Columbia University
A Remote Postpartum (PP) Blood Pressure Surveillance and Reminder System for Hypertensive Disorders of Pregnancy: A Randomized Clinical Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
213
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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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.
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Bluetooth-enabled blood pressure cuff to assess whether this technology helps providers collect more data regarding their patients' blood pressures in the postpartum period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood Pressure (BP) Surveillance Adherence
Time Frame: Up to 14 days from delivery hospitalization discharge
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Percentage of recommended twice-daily blood pressures reported between hospital discharge and first outpatient blood pressure assessment
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Up to 14 days from delivery hospitalization discharge
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Elevated Blood Pressure Percentage
Time Frame: Up to 14 days from delivery hospitalization discharge
|
Percentage of recorded blood pressure values at first outpatient blood pressure assessment that are elevated (>140 systolic or >90 diastolic)
|
Up to 14 days from delivery hospitalization discharge
|
Number of Participants With Outpatient BP Assessment Within 14 Days
Time Frame: Up to 14 days from delivery hospitalization discharge
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Number of participants who had a documented outpatient BP assessment within 14 days of hospital discharge
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Up to 14 days from delivery hospitalization discharge
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Incidence of BP Elevations
Time Frame: Up to 14 days from delivery hospitalization discharge
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Incidence of elevated blood pressure at outpatient blood pressure assessment
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Up to 14 days from delivery hospitalization discharge
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Number of Participants With Outpatient PP Assessment
Time Frame: Up to 8 weeks from delivery
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Number of participants who had an outpatient postpartum (PP) assessment
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Up to 8 weeks from delivery
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Incidence of BP Elevations
Time Frame: Up to 8 weeks from delivery
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Incidence of elevated blood pressure (BP) at the postpartum visit
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Up to 8 weeks from delivery
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Time to Medication Initiation
Time Frame: Up to 8 weeks from delivery
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Time to initiation of antihypertensive medications (in patients who were not on medications at time of discharge)
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Up to 8 weeks from delivery
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Number of Participants Initiated on Antihypertensive Therapy After Hospital Discharge
Time Frame: Up to 8 weeks from delivery
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Number of participants discharged from delivery hospitalization without antihypertensive therapy, who were subsequently started on antihypertensive therapy
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Up to 8 weeks from delivery
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Number of Participants Readmitted
Time Frame: Up to 8 weeks from delivery
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Number of participants who were readmitted after delivery hospitalization discharge
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Up to 8 weeks from delivery
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Number of Participants With ED Visit
Time Frame: Up to 8 weeks from delivery
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Number of participants who had an Emergency Department (ED) visit after delivery hospitalization discharge
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Up to 8 weeks from delivery
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Number of Participants Who Developed Preeclampsia-associated Complications
Time Frame: Up to 8 weeks from delivery
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Number of patients who experienced preeclampsia-related morbidity (eg: stroke, seizure, posterior reversible encephalopathy syndrome (PRES) , pulmonary edema, liver function abnormality, reversible cerebral vasoconstriction syndrome (RCVS) , renal insufficiency, thrombocytopenia) after delivery hospitalization discharge.
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Up to 8 weeks from delivery
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Number of Participants Referred to Primary Care for Continued Blood Pressure Management
Time Frame: Up to 8 weeks from delivery
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Number of participants who require a referral to primary care physicians for continued blood pressure management after being discharged from obstetric care at the postpartum visit
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Up to 8 weeks from delivery
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Score on the Modified Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ)
Time Frame: Up to 8 weeks from delivery
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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.
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Up to 8 weeks from delivery
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Change in Score on the Philips Program Survey
Time Frame: Up to 8 weeks from delivery
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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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Up to 8 weeks from delivery
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Communications
Time Frame: Up to 14 days post delivery hospitalization discharge
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Elevated blood pressures that led to communication with an obstetric provider
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Up to 14 days post delivery hospitalization discharge
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Leslie Moroz, MD, Columbia University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88. No abstract available.
- Bushnell C, McCullough LD, Awad IA, Chireau MV, Fedder WN, Furie KL, Howard VJ, Lichtman JH, Lisabeth LD, Pina IL, Reeves MJ, Rexrode KM, Saposnik G, Singh V, Towfighi A, Vaccarino V, Walters MR; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Council for High Blood Pressure Research. Guidelines for the prevention of stroke in women: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 May;45(5):1545-88. doi: 10.1161/01.str.0000442009.06663.48. Epub 2014 Feb 6. Erratum In: Stroke. 2014 Oct;45(10);e214. Stroke.2014 May;45(5):e95.
- Walters BN, Thompson ME, Lee A, de Swiet M. Blood pressure in the puerperium. Clin Sci (Lond). 1986 Nov;71(5):589-94. doi: 10.1042/cs0710589.
- Sibai BM. Etiology and management of postpartum hypertension-preeclampsia. Am J Obstet Gynecol. 2012 Jun;206(6):470-5. doi: 10.1016/j.ajog.2011.09.002. Epub 2011 Sep 16.
- Creanga AA, Berg CJ, Syverson C, Seed K, Bruce FC, Callaghan WM. Pregnancy-related mortality in the United States, 2006-2010. Obstet Gynecol. 2015 Jan;125(1):5-12. doi: 10.1097/AOG.0000000000000564.
- Clapp MA, Little SE, Zheng J, Robinson JN. A multi-state analysis of postpartum readmissions in the United States. Am J Obstet Gynecol. 2016 Jul;215(1):113.e1-113.e10. doi: 10.1016/j.ajog.2016.01.174.
- Levine LD, Nkonde-Price C, Limaye M, Srinivas SK. Factors associated with postpartum follow-up and persistent hypertension among women with severe preeclampsia. J Perinatol. 2016 Dec;36(12):1079-1082. doi: 10.1038/jp.2016.137. Epub 2016 Sep 1.
- Gandapur Y, Kianoush S, Kelli HM, Misra S, Urrea B, Blaha MJ, Graham G, Marvel FA, Martin SS. The role of mHealth for improving medication adherence in patients with cardiovascular disease: a systematic review. Eur Heart J Qual Care Clin Outcomes. 2016 Oct 1;2(4):237-244. doi: 10.1093/ehjqcco/qcw018.
- Goel A, Maski MR, Bajracharya S, Wenger JB, Zhang D, Salahuddin S, Shahul SS, Thadhani R, Seely EW, Karumanchi SA, Rana S. Epidemiology and Mechanisms of De Novo and Persistent Hypertension in the Postpartum Period. Circulation. 2015 Nov 3;132(18):1726-33. doi: 10.1161/CIRCULATIONAHA.115.015721. Epub 2015 Sep 28.
- Bryant AS, Haas JS, McElrath TF, McCormick MC. Predictors of compliance with the postpartum visit among women living in healthy start project areas. Matern Child Health J. 2006 Nov;10(6):511-6. doi: 10.1007/s10995-006-0128-5.
- Albini F, Xiaoqiu Liu, Torlasco C, Soranna D, Faini A, Ciminaghi R, Celsi A, Benedetti M, Zambon A, di Rienzo M, Parati G. An ICT and mobile health integrated approach to optimize patients' education on hypertension and its management by physicians: The Patients Optimal Strategy of Treatment(POST) pilot study. Annu Int Conf IEEE Eng Med Biol Soc. 2016 Aug;2016:517-520. doi: 10.1109/EMBC.2016.7590753.
- Clark SL, Belfort MA, Dildy GA, Englebright J, Meints L, Meyers JA, Frye DK, Perlin JA. Emergency department use during the postpartum period: implications for current management of the puerperium. Am J Obstet Gynecol. 2010 Jul;203(1):38.e1-6. doi: 10.1016/j.ajog.2010.02.033. Epub 2010 Apr 24.
- Al-Safi Z, Imudia AN, Filetti LC, Hobson DT, Bahado-Singh RO, Awonuga AO. Delayed postpartum preeclampsia and eclampsia: demographics, clinical course, and complications. Obstet Gynecol. 2011 Nov;118(5):1102-1107. doi: 10.1097/AOG.0b013e318231934c.
- Wenger NK, Arnold A, Bairey Merz CN, Cooper-DeHoff RM, Ferdinand KC, Fleg JL, Gulati M, Isiadinso I, Itchhaporia D, Light-McGroary K, Lindley KJ, Mieres JH, Rosser ML, Saade GR, Walsh MN, Pepine CJ. Hypertension Across a Woman's Life Cycle. J Am Coll Cardiol. 2018 Apr 24;71(16):1797-1813. doi: 10.1016/j.jacc.2018.02.033.
- Hirshberg A, Downes K, Srinivas S. Comparing standard office-based follow-up with text-based remote monitoring in the management of postpartum hypertension: a randomised clinical trial. BMJ Qual Saf. 2018 Nov;27(11):871-877. doi: 10.1136/bmjqs-2018-007837. Epub 2018 Apr 27.
- Tully KP, Stuebe AM, Verbiest SB. The fourth trimester: a critical transition period with unmet maternal health needs. Am J Obstet Gynecol. 2017 Jul;217(1):37-41. doi: 10.1016/j.ajog.2017.03.032. Epub 2017 Apr 5.
- ACOG Committee Opinion No. 736: Optimizing Postpartum Care. Obstet Gynecol. 2018 May;131(5):e140-e150. doi: 10.1097/AOG.0000000000002633.
- Too G, Wen T, Boehme AK, Miller EC, Leffert LR, Attenello FJ, Mack WJ, D'Alton ME, Friedman AM. Timing and Risk Factors of Postpartum Stroke. Obstet Gynecol. 2018 Jan;131(1):70-78. doi: 10.1097/AOG.0000000000002372.
- Arnhold M, Quade M, Kirch W. Mobile applications for diabetics: a systematic review and expert-based usability evaluation considering the special requirements of diabetes patients age 50 years or older. J Med Internet Res. 2014 Apr 9;16(4):e104. doi: 10.2196/jmir.2968.
- Rhoads SJ, Serrano CI, Lynch CE, Ounpraseuth ST, Gauss CH, Payakachat N, Lowery CL, Eswaran H. Exploring Implementation of m-Health Monitoring in Postpartum Women with Hypertension. Telemed J E Health. 2017 Oct;23(10):833-841. doi: 10.1089/tmj.2016.0272. Epub 2017 May 5.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 9, 2018
Primary Completion (Actual)
July 28, 2019
Study Completion (Actual)
May 11, 2020
Study Registration Dates
First Submitted
October 28, 2018
First Submitted That Met QC Criteria
October 31, 2018
First Posted (Actual)
November 2, 2018
Study Record Updates
Last Update Posted (Actual)
September 28, 2020
Last Update Submitted That Met QC Criteria
September 5, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAS0065
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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