App-based Remote Blood Pressure Monitoring

NCT05595629 | Completed Results

• 1 other identifier: WIH 21-0101
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Hypertension; Preeclampsia; Chronic Hypertension Complicating Pregnancy

Keywords

chronic or gestational hypertension, preeclampsia; remote blood pressure monitoring; smartphone application

Outcome Measures

Primary Outcomes (1)

• Blood Pressure Ascertainment

  Number of participants who adhere to recommended blood pressure check after hospital discharge

  3-10 days postpartum

Secondary Outcomes (5)

• Postpartum Readmission for Hypertension or Preeclampsia

  Within 30 days of hospital discharge, patient is readmitted for complications related to hypertension or preeclampsia

• Adherence to Evidence-based Practice

  From randomization until 6 weeks postpartum

• Postpartum Severe Maternal Morbidity Composite

  From randomization until 6 weeks postpartum

• "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"

  Assessed at randomization and at 40 days postpartum, reported at 40 days postpartum

• Decisional Regret Scale

  Assessed at randomization and at 40 days postpartum, reported at 40 days postpartum

Study Arms (2)

Text-message based remote blood pressure monitoring

ACTIVE COMPARATOR

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.

Behavioral: text-message based remote blood pressure monitoring

App-based remote blood pressure monitoring

EXPERIMENTAL

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.

Behavioral: App-based remote blood pressure monitoring

Interventions

App-based remote blood pressure monitoring BEHAVIORAL

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.

Also known as: Twistle

App-based remote blood pressure monitoring

text-message based remote blood pressure monitoring BEHAVIORAL

Participants will receive automatic blood pressure cuffs and instructions as to how to upload their measurements to the Electronic Medical Record.

Text-message based remote blood pressure monitoring

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Anyone who is postpartum--regardless of gender identity--will be eliglble to participate
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• a) fetal anomaly
• b) prisoners
• c) lack of smartphone
• d) inability to consent.

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead

Study Sites (1)

Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

Related Publications (1)

• Lewkowitz AK, Schlichting LE, Ayala NK, O'Neill A, McCleary KD, Hardy EJ, Hamel M, Tuuli MG. Association Between Hispanic Ethnicity and Engagement in a Remote Postpartum Blood Pressure Monitoring Programs: Secondary Analysis of a Pilot Randomized Trial. R I Med J (2013). 2024 Jun 3;107(6):17-18.

  PMID: 38810010 DERIVED

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Pre-Eclampsia; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Results Point of Contact

• Title: Adam Lewkowitz
• Organization: Women & Infants Hospital of Rhode Island

alewkowitz@kentri.org

401-274-1122

Study Officials

• Adam Lewkowitz, MD, MPHS

  Women and Infants Hospital of Rhode Island

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: October 27, 2022
• Study Start: November 7, 2022
• Primary Completion: June 30, 2023
• Study Completion: August 30, 2023
• Last Updated: February 19, 2025
• Results First Posted: February 19, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)