App-based Remote Blood Pressure Monitoring
Condition: Gestational Hypertension; Preeclampsia; Chronic Hypertension Complicating Pregnancy
MeSH terms: Pre-Eclampsia; Hypertension, Pregnancy-Induced; Pregnancy Complications; Hypertension
Study type: Interventional

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.
    

Intervention name(s): App-based remote blood pressure monitoring; text-message based remote blood pressure monitoring
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Fully synched bluetooth-enabled remote blood pressure monitoring using a smartphone application. The digital health company, Twistle, has modified an existing postpartum hypertension pathway in their app according to our hospital's management algorithm.; Participants will receive automatic blood pressure cuffs and instructions as to how to upload their measurements to the Electronic Medical Record.
Other intervention name(s): Twistle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: chronic or gestational hypertension, preeclampsia; remote blood pressure monitoring; smartphone application