Rhode Island - Statewide Postpartum Hypertension Remote Surveillance

Last updated: April 28, 2025
Sponsor: Women and Infants Hospital of Rhode Island
Overall Status: Active - Recruiting

Phase

N/A

Condition

Circulation Disorders

High Blood Pressure (Hypertension - Pediatric)

Diabetes And Hypertension

Treatment

RI-SPHERES

Standard self-measured blood pressure program

Clinical Study ID

NCT06842875
2184383
  • Ages 18-60
  • Female

Study Summary

This is a hybrid type 1 non-inferiority implementation effectiveness trial among postpartum patients with hypertension (N=1536) that will test the hypothesis that RI-SPHERES (a technologically enabled collaborative care model) is non-inferior to a standard self-measured blood pressure program in terms of persistent hypertension at six weeks postpartum and preventive care receipt within one year of delivery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Postpartum patient aged 18 years or more at any birthing hospital in Rhode Island

  • Diagnosed during pregnancy or after delivery with hypertensive disorder of pregnant

  • English-, Spanish-, Portuguese-, or Haitian-Creole-speaking

  • Smartphone ownership

Exclusion

Exclusion Criteria:

  • Prior enrollment in this trial

  • Prisoners or incarcerated people

  • Inability or unwillingness to provide informed consent

  • Inability to communicate with study team, despite an interpreter

Study Design

Total Participants: 1536
Treatment Group(s): 2
Primary Treatment: RI-SPHERES
Phase:
Study Start date:
April 14, 2025
Estimated Completion Date:
March 01, 2029

Study Description

Uncontrolled hypertensive disorders of pregnancy (HDP) are a major source of maternal mortality. National guidelines recommend blood pressure (BP) measurement 3-10 days after discharge and ≥1 preventive care visit within one year of delivery. Yet, barriers such as childcare or transportation issues reduce adherence to in-person BP checks, particularly among racial or ethnic minority patients. Programs in which patients self-measure BP (SMBP) at home show promising results regardless of patient race. However, a recent meta-analysis concluded current SMBP programs do not reduce maternal mortality or racial disparities in clinical outcomes, potentially due to their specific limitations: they end within six weeks of birth (though HDP can persist for months) and have decreased engagement with non-White people or those living in disadvantaged areas, though these populations are at the highest risk of persistent HTN and its adverse long-term effects. Thus, there is an urgent need to optimize SMBP programs to target short- and long-term HDP-related morbidity and to broadly implement these programs to eliminate disparities in HDP-related outcomes. One such program is Rhode Island (RI)-Statewide Postpartum HypErtension REmote Surveillance (RI-SPHERES), a technology-based SMBP program that aims to reduce short- and long-term HDP-associated morbidity in RI using the collaborative care model, a health services intervention that improves health outcomes and reduces racial disparities on a population level for people with chronic conditions. The proposed research aims to determine the effectiveness of RI-SPHERES in reducing short- and long-term morbidity associated with HDP throughout RI. This builds upon our pilot RCT (NCT05595629), in which a standard SMBP program was compared to a SMBP program that used a Bluetooth-enabled BP cuff that syncs to a smartphone application (app) to send automated reminders and provide adaptive messaging tailored to distinct BP values and symptoms. RI-SPHERES will expand this SMBP program to provide app-based patient-informed educational content on HDP-specific preventive care and bidirectional communication with RI-SPHERES staff for one year postpartum. Incorporating adaptive and automatic messaging increases RI-SPHERES' scalability by reducing clinical staff burden. However, formal analysis of factors that may hinder widespread implementation of RI-SPHERES is needed. Thus, we will conduct a Hybrid Type I Non-Inferiority Implementation-Effectiveness Trial among 1536 patients with HDP that compares a standard SMBP program to RI-SPHERES in terms of persistent HTN at six weeks postpartum and receipt of preventive care within one year of delivery (Specific Aim 1). We will examine the effect of both programs on increasing equity in terms of race, ethnicity, language, and geography for postpartum patients with HDP in Rhode Island (Specific Aim 2). We will also develop an implementation toolkit to facilitate the dissemination of RI-SPHERES (Specific Aim 3). The proposed project is expected to deliver a mechanism that will fill multiple research gaps for HDP identified by the US Preventive Services Task Force: 1) addressing health inequities through multilevel interventions, 2) evaluating SMBP programs; and 3) mitigating HDP's short- and long-term health consequences of HDP.

Connect with a study center

  • Newport Hospital

    Newport, Rhode Island 02840
    United States

    Site Not Available

  • Women & Infants Hospital of Rhode Island

    Providence, Rhode Island 02903
    United States

    Active - Recruiting

  • South County Hospital

    Wakefield, Rhode Island 02879
    United States

    Site Not Available

  • Kent Hospital

    Warwick, Rhode Island 02886
    United States

    Active - Recruiting

  • Landmark Hospital

    Woonsocket, Rhode Island 02895
    United States

    Site Not Available

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