Implementing an App-based Remote Blood Pressure Monitoring Program to Reduce Health Disparities Among Women With Hypertension During Pregnancy
Phase: NA
Conditions: Gestational Hypertension, Preeclampsia, Chronic Hypertension Complicating Pregnancy
Sponsor: Women and Infants Hospital of Rhode Island

 
 
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STUDY TITLE:   Implementing an app-based remote blood pressure monitoring program to reduce health 
disparities among women with hypertension during pregnancy 
 
PI NAME:  Adam Lewkowitz, MD, MPHS 
 
1. OBJECTIVES, SPECIFIC AIMS, BACKGROUND, AND SIGNIFICANCE 
Preeclampsia or gestational hypertension—described as hypertension in pregnancy—affects up to 10% of all 
pregnancies and is a main driver of maternal morbidity in Rhode Island and the United States.1-14 The rates of 
hypertension in pregnancy have disproportionately affected women of color and may explain why racial 
minorities have higher maternal morbidity.1,12 The American College of Obstetricians and Gynecologists has 
called for novel interventions to improve health equity and maternal morbidity outcomes among women 
hypertension in pregnancy. Technology-based interventions (i.e. remote blood pressure monitoring, telehealth 
visits, text-based communication) have improved access to care but, to date, have not yet demonstrated an 
effect on reducing maternal morbidity outcomes.15-17 It is possible that the lack of effect on maternal morbidity 
is due to the simplicity of the technology-based interventions previously employed (i.e. text message-based 
systems). Advanced digital health interventions on blood pressure--namely remote blood pressure monitoring 
through Bluetooth-enabled blood pressure cuffs and incorporation of a commercially available smartphone 
application that includes education and patient support as part of a "hypertension in pregnancy pathway"—may 
more effectively improve perinatal health equity compared to standard SMS-based messaging by reducing 
perinatal morbidity/mortality among women of color hypertension during their pregnancy. We propose a pilot 
randomized control trial to examine the feasibility, acceptability, and preliminary estimates of effects of 
smartphone application-based (app-based) Bluetooth enabled remote blood pressure monitoring (intervention 
group) when compared to a SMS (short message system such as text message) based remote blood pressure 
monitoring group (control group). Our long-term goal is to use the most cost-effective intervention (app-based 
vs SMS-based remote blood pressure monitoring) to improve health equity and maternal morbidity outcomes 
for pregnant women with hypertension during pregnancy who live in Rhode Island and beyond. We plan to use 
pilot data from this proposal to support an efficacy trial powered to detect differences in maternal morbidity 
outcomes between app-based remote blood pressure monitoring and routine care with SMS monitoring.  
In addition, this proposal stems from a hospital-wide effort at Women & Infants Hospital (WIH) to reduce racial 
disparities among women of color in terms of frequency of severe maternal morbidity (SMM). SMM is a metric 
created by the Centers for Disease Control and Prevention that includes blood transfusion as well as adverse 
outcomes ranging from arrhythmia to eclampsia to intubation.  SMM associated with hypertension is driven by 
asymptomatic postpartum hypertension. This is easily identified and managed prior to becoming SMM when 
patients adhere to recommended blood pressure checks after discharge. Excluding blood transfusion (which 
does not pertain to hypertension), the overall rate of SMM among women with hypertension during pregnancy 
who deliver at WIH is 6.6%. However, there is a significant difference along racial and ethnic lines: the rate of 
SMM in the setting of hypertension among black women is 6.8% compared to 4.5% among white women, and 
the rate of SMM in the setting of preeclampsia is 9.4% among Hispanic women compared to 4.9% among non-
Hispanic women. The overall dual aim of the initiative is to reduce the disparity in rates of SMM among those 
with hypertension between black and white women and between Hispanic and non-Hispanic women by at least 
33% by December 31, 2022. As part of WIH's equity initiative, automatic blood pressure cuffs (non Bluetooth 
enabled) will be provided to all women with hypertension at discharge from delivery hospitalization as part of 

 
 
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routine care. We plan to compare rates of SMM before versus after the hospital-wide implementation of SMS-
based remote blood pressure monitoring. Thus, for this proposal, we will build the foundation for our long-term 
goal and for hospital-wide equity projects by exploring whether app-based remote blood pressure monitoring is 
required to decrease maternal morbidity compared to standard care with remote SMS blood pressure 
monitoring. 
For this pilot study, sample size limitations will require the use of surrogate markers of maternal morbidity to 
serve as patient outcomes, which have been selected based on evidence-based best-practices.1-14  The 
primary clinical outcome for this study will be blood pressure measurement obtained three to ten days 
postpartum. Prespecified secondary outcomes include postpartum readmission for blood pressure 
management (e.g. rehospitalizations within 30 days of discharge), adherence to evidence-based best-practices 
(e.g. medications, antepartum surveillance, blood pressure ascertainment, postpartum blood pressure goal of 
<140/90), composite severe maternal morbidity (i.e. stroke, seizure/eclampsia, posterior reversible 
encephalopathy syndrome, pulmonary edema, heart failure, myocardial infarction, acute fatty liver of 
pregnancy, hemolysis, elevated liver enzymes and low platelets, placental abruption, post-partum hemorrhage, 
blood transfusion, acute kidney injury, and transaminitis), postpartum maternal mortality, and composite 
neonatal morbidity (i.e. umbilical artery pH <7.10, umbilical artery lactate, seizures, therapeutic hypothermia, 
hypoxic-ischemic encephalopathy, mechanical ventilation, intrauterine fetal death, neonatal death). We will 
also explore patient preferences as to treatment group via the Agency for Healthcare Research and Quality 
Consumer Assessment of Healthcare Providers and Systems (AHRQ CAHPS) survey and compared between 
both intervention groups and standard prenatal care.25 CAHPS survey will provide mixed quantitative and 
qualitative assessments. Our central hypothesis is that app-based Bluetooth enabled blood pressure 
monitoring will improve adherence to evidence-based best practices and will demonstrate signals towards 
improved health equity and maternal morbidity outcomes compared to SMS-based remote blood pressure 
monitoring. 
2. STUDY DESIGN, METHODS, AND PROCEDURES 
 
Study Design  
2.1 Study Design: We will conduct a pilot randomized control trial of 120 women who deliver at Women and 
Infant’s Hospital of Rhode Island (WIHRI) and plan to receive postpartum care at a WIHRI-affiliated clinic. We 
will use broad inclusion criteria and analyze data using the intention-to-treat principle to increase 
generalizability of the findings. 
2.2 Eligibility criteria: Inclusion criteria: a) English- or Spanish-speaking b) maternal age >18 years old, c) 
smartphone ownership for remote blood pressure ascertainment, d) diagnosis of gestational hypertension, 
preeclampsia, or chronic hypertension, e) plan to receive postpartum care at a Women & Infants Hospital 
(WIH)-affiliated clinic. Exclusion criteria: a) fetal anomaly, b) prisoners, c) lack of smartphone, and d) inability to 
consent.  
2.3 Screening, consent, and recruitment: Eligible women will be recruited at the Women and Infant’s Hospital 
of Rhode Island (WIHRI) ’s obstetrics units (obstetric triage, labor & delivery, antepartum care unit, and 
postpartum care unit) during their delivery hospitalization.  Recruitment will be conducted by a research 
assistant or study principal investigator or co-investigator. 
2.4 Randomization and blinding: Regardless of when their diagnosis of chronic hypertension, gestational 
hypertension, or preeclampsia with or without features occurs before or during delivery hospitalization, upon 
hospital discharge all patients will receive an automatic blood pressure cuff from WIHRI if their insurance does 
not cover this (or if they do not have one already); for patients whose insurance does cover automatic blood 
pressure cuffs, the provider will provide them with a prescription for this device at time of diagnosis. This is part 
of WIHRI’s equity initiative related to hypertension: as stated previously, WIHRI has committed to provide non-
Bluetooth enabled blood pressure cuffs to all eligible patients.  
Those who consent to participate in the study, complete baseline study surveys, and receive a blood 
pressure cuff prior to discharge will be randomized 1:1 via a computer-generated randomization sequence to 
one of two protocols: app based remote blood pressure monitoring (intervention group) or and standard PNC 
with SMS-based monitoring (comparison group). The study staff will remain blinded to intervention, except for 
the research assistant who will be, by necessity, unblinded.  

 
 
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They will receive the following per their randomization group: 
Standard care (comparison group) 
All women will receive education and counseling from their physician providers on evidence-based best-
practices and red-flags for pregnancy’s complicated by chronic hypertension, preeclampsia, or gestational 
hypertension. They will participate in WIHRI’s ongoing equity initiative using automatic blood pressure cuffs in 
a remote hypertension monitoring program supported by a nurse practitioner and community health worker. 
App-based remote blood pressure monitoring (intervention group) 
Women in this group will receive a Bluetooth-enabled automatic blood pressure cuff that sends messages 
through an affiliated smartphone application to providers upon recording each measurement. This affiliated 
smartphone application will also contain education on hypertension management. Upon receipt of the blood 
pressure cuff, participants will be instructed to set up the program/app such that the research assistant (RA) 
will receive all recorded blood pressure managements. All patients will receive instructions on how to obtain 
blood pressure and will be instructed to call their on-call provider if the blood pressure is >160/110 mmHg. The 
RA will review each patient’s blood pressure log daily to ensure blood pressures remain mild-range (i.e. 140-
159/90-109 mmHg) or less.  
2.5 Study procedures: Perinatal data will be collected and directly entered by the research assistant or 
principal investigators into REDCap, a secure database hosted by WIHRI. Data will be collected on a rolling 
basis to ensure timely collection and monitoring for unseen adverse events. 
Potential challenges and alternative approaches: Obtaining our target sample size may be challenging due to 
the incidence of hypertension diseases of pregnancy in the literature. However, we anticipate having a 
sufficient population from which to recruit for this pilot study given the 18 month study period and the relatively 
small sample study. However, should our target sample size be lower than expected, we may expand 
recruitment into private practice groups who have separate admitting privileges.  
 
Since starting recruitment, an additional challenge has developed: up to 10% of participants in the 
equity program (who may or may not be in the study) are discharged without blood pressure cuffs with the plan 
for a home visit to provide a BP cuff within 3-7 days after discharge. In addition, about 10% of patients who 
participated in the study did not complete their baseline study survey. To ensure we obtain a study population 
of 120 who follow the study protocol, we have developed an alternative approach by changing our inclusion 
criteria. Specifically, eligible people may be consented and randomized but only those who receive a BP cuff 
and complete their intake survey prior to discharge will be included in the trial’s analytic population. We 
anticipate needed to randomize up to 160 patients in order to obtain our desired study population of 120 
participants.  
 
2.6 Study outcomes and Power:  
Primary outcome: The primary outcomes will be adherence to recommended blood pressure check 3-10 days 
postpartum, as is recommended per standard of care. Our sample size of 120 pregnant women with 
gestational hypertension or preeclampsia will allow us to detect a 60% increase in adherence to recommended 
blood pressure check from the baseline rate of 50%, using a two-tailed alpha of 0.05. The 60% improvement 
(i.e. from 50% to 80% adherence) is conservative as it is less than has been reported in the medical 
literature.15-17 Secondary outcomes: Secondary outcomes will be surrogate markers of maternal morbidity.  
Prespecified secondary outcomes include postpartum readmission for blood pressure management (e.g. 
hospital admission for blood pressure management within 30 days of discharge), adherence to evidence-based 
best-practices (e.g. medications, blood pressure ascertainment, postpartum blood pressure goal of <140/90), 
composite severe maternal morbidity (Table 2), and composite neonatal morbidity (Table 1).  Our study will 
likely not be powered to detect differences in secondary outcomes due to the rarity of the individual patient 
outcomes but will provide us crucial pilot data for the subsequent study. 

 
 
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We will also explore patient preferences as to 
treatment group via the Agency for Healthcare 
Research and Quality Consumer Assessment of 
Healthcare Providers and Systems (AHRQ 
CAHPS) survey and compared between both 
intervention groups and standard prenatal care.25 
Per AHRQ guidelines, 100 CAHPS surveys must 
be completed in a pilot study to determine a 
difference in patient experience between care 
models.25 Our study population of 60 women per 
group (120 women total) is anticipated to 
generate ~100 completed surveys per group (200 
total), based on an anticipated response rate of 
80% and each participant completing two 
surveys. Upon enrollment, participants will 
choose whether they desire to complete the 
AHRQ CAHPS surveys in paper, online through 
email, or via a text-message platform; regardless 
of route, surveys will be collected at 
randomization and at ~30-45 days postpartum. 
On the second survey, participants will also complete a validated scale, the Decision Regret Scale.26 Of note, 
both the AHRQ CAHPS study and the Decision Regret Study are already validated in Spanish. 
2.6 Data Management, Sources of Materials, Records/Data to be reviewed: Antepartum, maternal/neonatal, 
pregnancy, and perinatal data will be collected and directly entered by the research assistant or principal 
investigator into REDCap, a secure database hosted by WIHRI. All primary and secondary outcomes will 
entered into REDCap by the RA or study team. Thus, the data to be reviewed will only be collected by key 
study personnel. In addition, pregnancy characteristics (maternal weight, disease comorbidities, etc.) and 
demographic information (reported race/ethnicity, insurance type, zip code) will be collected post-delivery and 
entered into REDCap.  Prior to data analysis, all patient identifiable information will be stripped to ensure 
patient confidentiality. Our REDCap database will be encrypted by multiple levels of password protection 
(accessing computer, network, and logging into database) that will only be accessible by key research 
personell. Anti-virus software is installed and up to date and the operating system is up to date with all 
Windows and Apple updates.  
Material/Specimen Management: No specimens will be stored outside of standard care (such as umbilical 
cord gases processed by laboratory per usual clinical protocol).  
Provisions to monitor the data to ensure the safety of subjects: Our study does not involve greater than 
minimal risk. However, we will monitor for unanticipated adverse outcomes. As a part of this, key study 
personnel (Drs. Polnaszek, Lewkowitz) will monitor for adverse outcomes on a weekly basis. Should any 
unanticipated outcomes be found, this will be reported back to the IRB. Beyond the weekly monitoring of 
patients/data, this will also be performed globally on a quarterly basis.  
Withdrawal of subjects: Patients will not be withdrawn from the study.  
2.7 Data analysis: Analysis will follow the intention-to-treat principle. Continuous variables will be compared 
using the Student’s t-test or Mann Whitney U test, as appropriate. Categorical variables will be compared using 
the χ2 or Fisher’s exact test, as appropriate. We will calculate crude and unadjusted risk ratios and differences. 
We will use multivariable logistic regression to adjust for potential confounders. Qualitative data obtained from 
CAHPS survey will also be analyzed using Nvivo, a computer-assisted qualitative data analysis software 
provided by Brown University. This software promotes inquiry beyond coding, sorting and retrieval of data. It is 
designed to integrate coding with qualitative linking, shaping, and modeling that may inform health equitable 
care. Dr. Lewkowitz and Polnaszek have used Nvivo softward. In addition, Dr. Polnaszek has utilized this 
procedure to capture qualitative data previously to successfully design, implement, and launch a new model of 
health care for vulnerable patients transitioning from the hospital to sub-acute care facilities.27  
2.8 Plan to include a diverse population 

 
 
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Inclusion of minorities: This proposal aims to reduce health inequity among women of color with gestational 
hypertension, preeclampsia, or chronic hypertension. Rates of hypertensive disease in pregnancy are higher 
among minority women. Given this is our target population, we anticipate that a significant proportion of women 
included in our study will be minorities.  Recruitment will be conducted at prenatal clinics by a research 
assistant or member of the study team. 
Inclusion of fetuses, neonates, and pregnant women: Recent data suggests utilizing remote blood pressure 
monitoring via text messaging and automatic blood pressure cuffs improves adherence to recommended 
care.15-17 As this practice should become standard of care, WIHRI plans to implement SMS-based remote 
blood pressure monitoring hospital wide for all eligible patients. However, the effect of SMS-based messaging 
on reducing maternal morbidity outcomes pertaining to hypertension is unknown. In this pilot study, we will 
compare standard of care (SMS-based remote blood pressure monitoring) to a high quality digital health 
intervention (smartphone app provided patient education and linked Bluetooth-enabled blood pressure 
monitoring). This innovative study will allow us to obtain pilot data to determine whether additional digital health 
support (Bluetooth enabled cuff and app-provided education) is more effective at improve health equity among 
women of color who deliver at WIH when compared to standard care (SMS-based remote blood pressure 
monitoring). 
3.9 Participant Reimbursement: No reimbursement will be provided for participation, but all participants who 
complete all required surveys will be entered into a raffle with a prize of $100 
 
 
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