Rhode Island - Statewide Postpartum Hypertension Remote Surveillance
RI-SPHERES
Effect of a Technology-based Collaborative Model on Persistent Hypertension and Preventive Care Attendance Among Postpartum People With Hypertensive Disorders of Pregnancy
1 other identifier
interventional
1,536
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2025
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2025
CompletedFirst Posted
Study publicly available on registry
February 24, 2025
CompletedStudy Start
First participant enrolled
April 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2029
June 17, 2025
February 1, 2025
3.9 years
February 18, 2025
June 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Persistent hypertension
Persistent stage II hypertension will be defined as systolic blood pressure of 140 mmHg or higher and/or diastolic blood pressure of 90 mmHg or higher
Six weeks postpartum
Secondary Outcomes (14)
Attendance of preventive care visit
From six weeks postpartum until one year postpartum
Blood pressure ascertainment
1-10 days after hospital discharge
Total number of self-measured blood pressure assessments provided to program in immediate postpartum period
Hospital discharge to six weeks postpartum
Total number of self-measured blood pressure assessments provided to program after six weeks postpartum
Six weeks postpartum until one year postpartum
Severe maternal morbidity after hospital discharge
Hospital discharge until 6 weeks postpartum
- +9 more secondary outcomes
Study Arms (2)
RI-SPHERES
EXPERIMENTALA 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.
Standard self-measured blood pressure program
ACTIVE COMPARATOROur 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
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Women and Infants Hospital of Rhode Islandlead
- Brown Universitycollaborator
- Kent Hospital, Rhode Islandcollaborator
Study Sites (5)
Newport Hospital
Newport, Rhode Island, 02840, United States
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02903, United States
South County Hospital
Wakefield, Rhode Island, 02879, United States
Kent Hospital
Warwick, Rhode Island, 02886, United States
Landmark Hospital
Woonsocket, Rhode Island, 02895, United States
Related Publications (1)
Nunez SD, Spratt LM, Ware CF, Machado S, Rousseau J, Jackson TL, Buckley J, Magee S, Wohler D, Blosser E, Sales S, Simmons D, Ramos VN, Castillo MM, Murray C, Bailey K, Gutman R, Richardson CR, Grobman WA, Hauspurg A, Miller ES, Tuuli MG, Lewkowitz AK. Protocol for a type 1 hybrid effectiveness implementation trial to evaluate whether a technology-based collaborative care model is non-inferior to remote blood pressure monitoring on persistent hypertension and preventive care attendance among postpartum people with hypertension. Contemp Clin Trials. 2025 Dec;159:108114. doi: 10.1016/j.cct.2025.108114. Epub 2025 Oct 23.
PMID: 41139061DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Both remote hypertension monitoring programs are managed by a different nurse practitioner who, by necessity, will not be masked. However, all care providers who provide perinatal care for enrolled participants will be masked to their patient's study group.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2025
First Posted
February 24, 2025
Study Start
April 15, 2025
Primary Completion (Estimated)
March 1, 2029
Study Completion (Estimated)
March 1, 2029
Last Updated
June 17, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- 5 years after completion of study
- Access Criteria
- The investigators will make the data and associated documentation available to users under a data-sharing agreement that provides for commitment to: a) using the data only for research purposes and not to identify any individual participant; b) securing the data using appropriate computer technology; and c) destroying or returning the data after analyses are completed. Timelines for distribution of data will vary depending on any required restrictions as mentioned above. Data may be distributed by a number of electronic methods, including web-based databases, datasets, and spreadsheets, or via electronic media such as compact discs.
Data will be collected from human subjects and will be shared according to NIH guidelines. The investigators are committed to the sharing of final data, being mindful that the rights and privacy of people who participate in research must be protected at all times. The investigators will make a complete study dataset available for sharing. The investigators will have a description of study dataset, including code books, meta-data related to the dataset, and documented programming code used for creating the final study population, for creating variables, and for conducting all outcomes analyses. The investigators will remain HIPAA compliant, and therefore any datasets resulting from participants will be free of any identifiers that would permit linkages to individual research participants and variables that could lead to deductive disclosure of individual subjects.