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App-based Remote Blood Pressure Monitoring

Primary Purpose

Gestational Hypertension, Preeclampsia, Chronic Hypertension Complicating Pregnancy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
App-based remote blood pressure monitoring
text-message based remote blood pressure monitoring
Sponsored by
Women and Infants Hospital of Rhode Island
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gestational Hypertension focused on measuring chronic or gestational hypertension, preeclampsia, remote blood pressure monitoring, smartphone application

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Women & Infants Hospital of Rhode Island

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Text-message based remote blood pressure monitoring

App-based remote blood pressure monitoring

Arm Description

Women in this group will receive current standard of care: remote blood pressure monitoring via text message. Specifically, they will receive automatic blood pressure cuffs, instructions how to obtain their blood pressures and log them into our Electronic Medical Record, and contact information for the nurse practitioner and community health worker managing the program. The NP will respond via text message to each individual measurement with instructions as to next steps.

Women in this group will receive a Bluetooth-enabled automatic blood pressure cuff that synchs automatically to a smartphone application that incorporates Artificial Intelligence to respond to each recorded measurements with recommended next steps and also document the measurement and response in a secure platform. 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.

Outcomes

Primary Outcome Measures

Blood pressure ascertainment
Adherence to recommended blood pressure check after hospital discharge

Secondary Outcome Measures

postpartum readmission for hypertension or preeclampsia
Readmission rate for HTN/preeclampsia
Adherence to evidence-based practice
Medication initiation/titration, postpartum blood pressure goal of <150/100
Postpartum severe maternal morbidity composite
Stroke, seizure/eclampsia, acute fatty liver of pregnancy, posterior reversible encephalopathy syndrome, pulmonary edema, heart failure, hemolysis elevated liver enzymes and low platelets, placental abruption, postpartum hemorrhage, acute kidney injury, transaminitis
Agency for Healthcare Research and Quality Consumer Assessment of Healthcare Providers and Systems survey (AHRQ CAHPS)
Patient preference of treatment group
Decisional Regret Scale
Extent to which participant regrets participating in a treatment group. To help interpret the score more readily with other scales ranging from 0 to 100, these scores can then be converted to a 0-100 scale by subtracting 1 from each item then multiply by 25. To obtain a final score, the items are summed and averaged. A score of 0 means no regret; a score of 100 means high regret.

Full Information

First Posted
October 4, 2022
Last Updated
September 12, 2023
Sponsor
Women and Infants Hospital of Rhode Island
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1. Study Identification

Unique Protocol Identification Number
NCT05595629
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 7, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
August 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Women and Infants Hospital of Rhode Island

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Hypertension, Preeclampsia, Chronic Hypertension Complicating Pregnancy
Keywords
chronic or gestational hypertension, preeclampsia, remote blood pressure monitoring, smartphone application

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Participants who consent will be unaware of the existence of the other remote blood pressure monitoring program. The nurse practitioner who manages postpartum hypertension for all participants will be aware of randomization group but will manage each participant per a standard treatment algorithm regardless of randomization group. The research team and outcomes assessors will be blinded to the randomization group.
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Text-message based remote blood pressure monitoring
Arm Type
Active Comparator
Arm Description
Women in this group will receive current standard of care: remote blood pressure monitoring via text message. Specifically, they will receive automatic blood pressure cuffs, instructions how to obtain their blood pressures and log them into our Electronic Medical Record, and contact information for the nurse practitioner and community health worker managing the program. The NP will respond via text message to each individual measurement with instructions as to next steps.
Arm Title
App-based remote blood pressure monitoring
Arm Type
Experimental
Arm Description
Women in this group will receive a Bluetooth-enabled automatic blood pressure cuff that synchs automatically to a smartphone application that incorporates Artificial Intelligence to respond to each recorded measurements with recommended next steps and also document the measurement and response in a secure platform. 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.
Intervention Type
Behavioral
Intervention Name(s)
App-based remote blood pressure monitoring
Other Intervention Name(s)
Twistle
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
text-message based remote blood pressure monitoring
Intervention Description
Participants will receive automatic blood pressure cuffs and instructions as to how to upload their measurements to the Electronic Medical Record.
Primary Outcome Measure Information:
Title
Blood pressure ascertainment
Description
Adherence to recommended blood pressure check after hospital discharge
Time Frame
3-10 days postpartum
Secondary Outcome Measure Information:
Title
postpartum readmission for hypertension or preeclampsia
Description
Readmission rate for HTN/preeclampsia
Time Frame
Within 30 days of hospital discharge, patient is readmitted for complications related to hypertension or preeclampsia
Title
Adherence to evidence-based practice
Description
Medication initiation/titration, postpartum blood pressure goal of <150/100
Time Frame
From randomization until 6 weeks postpartum
Title
Postpartum severe maternal morbidity composite
Description
Stroke, seizure/eclampsia, acute fatty liver of pregnancy, posterior reversible encephalopathy syndrome, pulmonary edema, heart failure, hemolysis elevated liver enzymes and low platelets, placental abruption, postpartum hemorrhage, acute kidney injury, transaminitis
Time Frame
From randomization until 6 weeks postpartum
Title
Agency for Healthcare Research and Quality Consumer Assessment of Healthcare Providers and Systems survey (AHRQ CAHPS)
Description
Patient preference of treatment group
Time Frame
At randomization and again at 40 days postpartum
Title
Decisional Regret Scale
Description
Extent to which participant regrets participating in a treatment group. To help interpret the score more readily with other scales ranging from 0 to 100, these scores can then be converted to a 0-100 scale by subtracting 1 from each item then multiply by 25. To obtain a final score, the items are summed and averaged. A score of 0 means no regret; a score of 100 means high regret.
Time Frame
At randomization and again at 40 days postpartum

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Anyone who is postpartum--regardless of gender identity--will be eliglble to participate
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Lewkowitz, MD, MPHS
Organizational Affiliation
Women and Infants Hospital of Rhode Island
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women & Infants Hospital of Rhode Island
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data from this small pilot will not be made available to other researchers.

Learn more about this trial

App-based Remote Blood Pressure Monitoring

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