RI-SPHERES for Postpartum Hypertension

(RI-SPHERES Trial)

Recruiting at 4 trial locations

Overseen By Stephanie Nunez, Research Coordinator

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Women and Infants Hospital of Rhode Island

Disqualifiers: Prior enrollment, Prisoners, Inability to consent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1536 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help postpartum individuals manage high blood pressure. It compares a tech-based care model, RI-SPHERES, where participants use a blood pressure cuff connected to an app, with a standard program where they manually track their blood pressure. The goal is to determine if this new method effectively controls blood pressure and ensures preventive care within a year after delivery. Participants should have experienced high blood pressure during or after pregnancy and own a smartphone. As an unphased trial, this study allows participants to contribute to innovative healthcare solutions that could enhance postpartum care.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the RI-SPHERES model is safe for postpartum hypertension patients?

Research shows that self-measured blood pressure programs, such as RI-SPHERES, can help manage high blood pressure after childbirth. These programs use technology to monitor blood pressure and send reminders. Participants use a blood pressure cuff that connects to a smartphone app, which sends reminders and messages based on their readings.

Although specific safety data for RI-SPHERES is not available, similar programs have been safely used to manage blood pressure, suggesting that RI-SPHERES should also be safe. The technology does not involve new medications or invasive procedures, which typically means fewer safety concerns.

Clinical trials often have different stages to test safety and effectiveness. Although this trial is labeled "Not Applicable" for phases, earlier stages usually focus on safety. Testing RI-SPHERES with many people suggests that earlier tests have shown it to be safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the RI-SPHERES approach for postpartum hypertension because it offers a tech-savvy, personalized care model that stands out from traditional methods. Unlike standard self-measured blood pressure programs, RI-SPHERES uses an LTE-enabled blood pressure cuff that syncs with a smartphone app to send automated reminders and provide tailored messages based on specific blood pressure readings and symptoms. This adaptive approach not only focuses on blood pressure control for the first six weeks but also helps transition participants to preventive care, all guided by a weekly collaborative team led by a nurse practitioner. This innovative use of technology and collaborative care could enhance patient engagement and outcomes, making it a promising advancement in managing postpartum hypertension.

What evidence suggests that RI-SPHERES is effective for postpartum hypertension?

Research has shown that RI-SPHERES, a treatment option in this trial, is a tech-based care model that could help manage high blood pressure after childbirth. This program uses a blood pressure cuff connected to a smartphone app, which sends reminders and messages based on the user's readings. Studies suggest that programs like RI-SPHERES improve blood pressure control and ensure new mothers receive preventive care. By focusing on managing blood pressure for six weeks before shifting to preventive care, RI-SPHERES aims to maintain healthier blood pressure levels in new mothers. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for postpartum patients with hypertension. It's designed to see if a new care model called RI-SPHERES, which uses technology and team-based care, can manage blood pressure as effectively as standard self-monitoring after giving birth.

Inclusion Criteria

I am over 18 and gave birth in a Rhode Island hospital.

Smartphone ownership

I was diagnosed with high blood pressure during or after my pregnancy.

Exclusion Criteria

Prisoners or incarcerated people

Inability or unwillingness to provide informed consent

Prior enrollment in this trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Initial Treatment

Participants use a self-measured blood pressure (SMBP) program with a focus on blood pressure control

6 weeks

Daily self-measurements

Transition to Preventive Care

Participants transition to receiving recommended preventive care with continued monitoring

From 6 weeks postpartum until one year postpartum

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 12 months postpartum

What Are the Treatments Tested in This Trial?

Interventions

• RI-SPHERES
• Standard self-measured blood pressure program

Trial Overview

The study compares RI-SPHERES—a tech-enabled collaborative care approach—to the usual way of monitoring blood pressure by oneself in postpartum women with high blood pressure. The goal is to check if this new method prevents long-term hypertension.

How Is the Trial Designed?

Group I: RI-SPHERES Experimental Treatment 1 Intervention

A technology enabled collaborative care model. Participants will receive a LTE-enabled blood pressure (BP) cuff that syncs to a smartphone application (app) to send automated reminders and provide adaptive messaging tailored to distinct BP values and symptoms. The first six weeks of the program will focus on BP control, and the remaining time will help transition people to receive recommended preventive care. As part of the collaborative care model, the nurse practitioner will lead weekly meetings with a multidisciplinary clinical team about all enrolled people.

Group II: Standard self-measured blood pressure program Active Control 1 Intervention

Our hospital has a remote hypertension monitoring program that recommends daily blood pressure ascertainment for 6 weeks, at which time they are discharged and provided printed resources to encourage preventive care in the next few months. In this program, patients manually enter their self-measured BPs into the electronic medical record for the clinical team to manually review and respond.

Who Is Running the Clinical Trial?

Women and Infants Hospital of Rhode Island

Lead Sponsor

Trials

119

Recruited

59,200+

Kent Hospital, Rhode Island

Collaborator

Trials

4

Recruited

2,000+

Brown University

Collaborator

Trials

480

Recruited

724,000+

Published Research Related to This Trial

In a study of 1,964 women, 2.9% developed a postpartum-onset hypertensive disorder, highlighting the need for awareness of this condition after delivery.

Key risk factors for developing postpartum hypertension include assisted reproductive technology, high pre-pregnancy body mass index, chronic nephritis, hypothyroidism, elevated blood pressure during pregnancy, and cesarean delivery, suggesting that women with these factors should be closely monitored for blood pressure changes post-delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical features and antenatal risk factors for postpartum-onset hypertensive disorders. Takaoka, S., Ishii, K., Taguchi, T., et al.[2022]

There is currently no strong evidence to recommend a specific treatment for postpartum hypertension, as highlighted by a review of 23 studies, indicating a significant gap in research.

Calcium channel blockers, beta-blockers, alpha-blockers, and ACE inhibitors showed varying effectiveness, but more comparative studies are needed to determine the best therapy for managing high blood pressure after delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical management of hypertensive disorders in postpartum women. Scudo, M., Petruzziello, L., Carbone, F., et al.[2022]

This randomized controlled trial involving 186 women with postpartum hypertension demonstrated that self-management, which included daily blood pressure monitoring and telemonitoring for medication adjustments, was feasible and led to better blood pressure control compared to usual care.

The intervention group showed significantly lower blood pressure, particularly diastolic pressure, at 6 weeks and maintained better control up to 6 months, suggesting that self-management could be an effective strategy for managing postpartum hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-Management of Postnatal Hypertension: The SNAP-HT Trial. Cairns, AE., Tucker, KL., Leeson, P., et al.[2021]

In a study of 460 women with hypertensive disorders in pregnancy, 88.7% experienced a return to normal blood pressure levels by 42 days postpartum, indicating a generally positive recovery trend after delivery.

Risk factors that may hinder the recovery of postpartum blood pressure include advanced maternal age, a higher severity of hypertensive disorders during pregnancy, and having both high systolic and diastolic blood pressures, suggesting that these women require closer monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Postpartum change of blood pressure and its risk factors in patients with hypertensive disorders in pregnancy]. Shen, L., Tan, H., Zhou, S., et al.[2018]

Diuretics have been shown to effectively reduce postpartum hypertension in women with hypertensive disorders of pregnancy, highlighting a potential treatment option for managing this condition.

Innovations like telemedicine and machine learning risk prediction models are enhancing the monitoring and management of postpartum hypertension, which may lead to better long-term health outcomes for women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Best Practices for Managing Postpartum Hypertension. Kumar, NR., Hirshberg, A., Srinivas, SK.[2022]

A systematic review of 39 studies involving 2901 postnatal women with hypertensive disorders of pregnancy found that while calcium-channel blockers, vasodilators, and beta-blockers can lower blood pressure postpartum, there is insufficient evidence to recommend any specific pharmacological intervention due to variability in effectiveness.

Uterine curettage was shown to significantly reduce blood pressure in the first 48 hours postpartum compared to standard care, but safety data was limited, preventing a strong recommendation for its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postpartum management of hypertensive disorders of pregnancy: a systematic review. Cairns, AE., Pealing, L., Duffy, JMN., et al.[2023]

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RI-SPHERES for Postpartum Hypertension

This suggests that similar self-measured blood pressure programs, like RI-SPHERES, could be effective in managing postpartum hypertension.

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Journal Pre-proof

After six weeks postpartum, RI-SPHERES will ... postpartum hypertension by optimizing blood pressure control and preventive care receipt.

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RI-SPHERES integrates UTMHealthcare's secure, scalable RPM platform to enable remote blood pressure monitoring for postpartum patients, offering both app-based ...

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The Rhode Island - Statewide Postpartum Hypertension Remote Surveillance trial is studying how effective a new care model, called RI-SPHERES, is for women who ...

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For Primary Care Providers

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