Actively Recruiting
Led by Women and Infants Hospital of Rhode Island · Updated on 2025-06-17
1536
Participants Needed
5
Research Sites
N/A
Total Duration
W
Women and Infants Hospital of Rhode Island
Lead Sponsor
B
Brown University
Collaborating Sponsor
This research aims to evaluate a technology-based collaborative care model called RI-SPHERES among postpartum patients with hypertensive disorders of pregnancy (HDP). The trial will test whether RI-SPHERES is not worse than a standard self-measured blood pressure (SMBP) program in controlling persistent hypertension six weeks after delivery and improving preventive care attendance within one year. The study addresses challenges like low adherence to blood pressure checks due to barriers such as childcare and transportation, especially in racial or ethnic minority groups. Participants will be randomly assigned to one of two groups: the RI-SPHERES group or the standard SMBP program group. The RI-SPHERES group will use a LTE-enabled blood pressure cuff syncing to a smartphone app that sends automated reminders and adaptive messages based on blood pressure readings and symptoms, with a nurse practitioner-led collaborative care team supporting patients. The first six weeks focus on blood pressure control, then shift to preventive care support for up to one year. The standard SMBP group will manually enter blood pressure readings into an electronic record to be reviewed by clinical staff, with recommendations for monthly blood pressure checks and preventive care after six weeks postpartum. Participants will be involved for one year postpartum, during which blood pressure measurements, preventive care visits, and maternal health outcomes will be monitored. Assessments include short- and long-term blood pressure control, severe maternal morbidity, emergency visits, hospital readmissions, medication adjustments, and patient satisfaction. The study will also evaluate equity in care related to race, ethnicity, language, and geography. Data will be collected through the app, electronic medical records, and regular communications with the study team to track adherence and health outcomes.
CONDITIONS
Rhode Island - Statewide Postpartum Hypertension Remote Surveillance
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or virtual)
Duration - Up to 1 year postpartum
Participants engage in a self-measured blood pressure program. Those in the RI-SPHERES group use a Bluetooth-enabled blood pressure cuff synced to an app with automated reminders and adaptive messaging for the first six weeks postpartum. After six weeks, the focus shifts to preventive care with monthly engagement from a care manager to ensure primary care and specialist visits. Participants in the standard program manually report blood pressure readings and receive guidance to attend preventive care visits after six weeks.
Weekly or monthly virtual or in-person contacts depending on study group, including initial introduction and ongoing support
Duration - From six weeks postpartum until one year postpartum
Participants continue to be monitored for persistent hypertension and attendance of preventive care visits up to one year postpartum.
Monthly check-ins and preventive care visits as recommended
Total: 5 locations
1
Newport Hospital
Newport, Rhode Island, United States, 02840
Not Yet Recruiting
2
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02903
Actively Recruiting
3
South County Hospital
Wakefield, Rhode Island, United States, 02879
Not Yet Recruiting
4
Kent Hospital
Warwick, Rhode Island, United States, 02886
Actively Recruiting
5
Landmark Hospital
Woonsocket, Rhode Island, United States, 02895
Actively Recruiting
S
Stephanie Nunez, Research Coordinator
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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Stephanie D Nuñez, Lindsay M Spratt, Crystal F Ware...
https://pubmed.ncbi.nlm.nih.gov/41139061