Clinical trial NCT05595629: App-based Remote Blood Pressure Monitoring
Official title: Implementing an App-based Remote Blood Pressure Monitoring Program to Reduce Health Disparities Among Women With Hypertension During Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Hypertension
Preeclampsia
Chronic Hypertension Complicating Pregnancy
Keywords: chronic or gestational hypertension, preeclampsia
remote blood pressure monitoring
smartphone application
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
First posted: 2022-10-27
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Remote postpartum blood pressure monitoring program with text messages has been shown to increase adherence to recommended postpartum blood pressure checks among those with hypertension at discharge from birth hospitalization, but these programs require medically trained professionals to respond to each individual text message. A bluetooth-enabled blood pressure cuff that synchs automatically a smartphone application that leverages Artificial Intelligence to provide tailored recommendations based on recorded blood pressure measurements--and can also provide on-demand education on hypertension--may be less costly way to provide similar support.

Detailed description: 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. The rates of hypertension in pregnancy have disproportionately affected women of color and may explain why racial minorities have higher maternal morbidity. 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. 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.

The investigators 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). The investigators' 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. The investigators 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 consenting women with hypertension at discharge from delivery hospitalization as part of routine care. In this study, rates of SMM before the hospital-wide implementation of SMS-based remote blood pressure monitoring will be compared to those after. Thus, for this proposal, this proposal exploring whether app-based remote blood pressure monitoring is required to decrease maternal morbidity compared to standard care with remote SMS blood pressure monitoring.

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 at hospital discharge
* 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
* d) inability to consent.

Primary outcomes:
measure: Blood Pressure Ascertainment
timeFrame: 3-10 days postpartum
Secondary outcomes:
measure: Postpartum Readmission for Hypertension or Preeclampsia
timeFrame: Within 30 days of hospital discharge, patient is readmitted for complications related to hypertension or preeclampsia
measure: Adherence to Evidence-based Practice
timeFrame: From randomization until 6 weeks postpartum
measure: Postpartum Severe Maternal Morbidity Composite
timeFrame: From randomization until 6 weeks postpartum
measure: "Using Any Number From 0 to 10 Where 0 is the Worst Possible Experience and 10 is the Best Possible Experience, Please Rate Your Experience in the Postpartum Hypertension Program"
timeFrame: Assessed at randomization and at 40 days postpartum, reported at 40 days postpartum
measure: Decisional Regret Scale
timeFrame: Assessed at randomization and at 40 days postpartum, reported at 40 days postpartum
Other outcomes:
Locations:
city: Providence
country: United States
facility: Women & Infants Hospital of Rhode Island
state: Rhode Island
Study officials:
affiliation: Women and Infants Hospital of Rhode Island
name: Adam Lewkowitz, MD, MPHS
role: PRINCIPAL_INVESTIGATOR
References: