Recruiting

RI-SPHERES vs. Standard Program

Sponsor:

Women and Infants Hospital of Rhode Island

Code:

NCT06842875

Conditions

Hypertension in Pregnancy

Postpartum Preeclampsia

Postpartum Complication

Eligibility Criteria

Sex: Female

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

RI-SPHERES

Standard self-measured blood pressure program

Study Details

Brief 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.

Conditions

Hypertension in Pregnancy

Postpartum Preeclampsia

Postpartum Complication

Study ID

NCT06842875

Start date

Apr 15, 2025

Status verified date

Feb, 2025

Completion date

Mar 1, 2029

Anticipated

Primary completion date

Mar 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 60

Healthy Volunteers: Not accepted

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 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

Enrollment

1536 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: RI-SPHERES

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.

active comparator: Standard self-measured blood pressure program

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.

Interventions

RI-SPHERES

Participants assigned to the RI-SPHERES group will be introduced virtually or in-person to the care manager (CM), who demonstrate how to communicate directly with patients through the app for medical or non-medical needs. Each participant will learn how to obtain SMBP, sync the LTE-enabled BP cuff to the RI-SPHERES app, and respond to adaptive messaging pertaining to BP measurements, which include the ability to receive on-demand education on postpartum topics (e.g., HDP, breastfeeding, mood disorders) per participant preference. During the study period, the CM will respond to needs elicited from the SDoH screening by facilitating referrals to community resources. After six weeks, the focus of RI-SPHERES will transition to preventive care in addition to SMBP. The CM will engage monthly with each study participant to ensure they have a primary care provider and to facilitate preventive care visits or specialist appointments, if needed.

Standard self-measured blood pressure program

Participants assigned to the routine care group meet virtually or in-person with a member of WIH's existing SMBP program and enroll in WIH's EPIC MyChart Portal to allow the SMBP program to receive patient-entered BP measurements and respond to messages. Participants will be provided with BP cuffs and taught how to obtain SMBP and report their BP through MyChart. At six weeks postpartum, WIH SMBP staff send a MyChart message to recommend BP ascertainment once per month and to describe the importance of attending a clinical visit with a primary care provider within a year of birth.

Primary outcome measure

  • Persistent hypertension [ Time Frame: Six weeks postpartum ]

Central Contacts and Locations

Central contacts

Stephanie Nunez, Research Coordinator

401-274-1122snunez@wihri.org

Locations

Women & Infants Hospital of Rhode Island

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Principal Investigator:

Adam Lewkowitz, MD, MPHS

Kent Hospital

Recruiting

Warwick, Rhode Island, United States, 02886

Contacts

Principal Investigator:

Caroline Richardson, MD

Landmark Hospital

Recruiting

Woonsocket, Rhode Island, United States, 02895

Contacts

More Information

Sponsor

Women and Infants Hospital of Rhode Island

Last update posted

Jun 17, 2025

Last verified

Feb, 2025

Keywords

  • postpartum hypertensive disorders of pregnancy
  • postpartum preeclampsia
  • digital health
  • collaborative care model
  • population health
  • self-measured blood pressure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Women and Infants Hospital of Rhode Island on 2025-06-17.