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RECRUITING
NCT06842875
NA

Rhode Island - Statewide Postpartum Hypertension Remote Surveillance

Sponsor: Women and Infants Hospital of Rhode Island

View on ClinicalTrials.gov

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.

Official title: Effect of a Technology-based Collaborative Model on Persistent Hypertension and Preventive Care Attendance Among Postpartum People With Hypertensive Disorders of Pregnancy

Key Details

Gender

FEMALE

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

1536

Start Date

2025-04-15

Completion Date

2029-03-01

Last Updated

2025-06-17

Healthy Volunteers

No

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

Locations (5)

Newport Hospital

Newport, Rhode Island, United States

Women & Infants Hospital of Rhode Island

Providence, Rhode Island, United States

South County Hospital

Wakefield, Rhode Island, United States

Kent Hospital

Warwick, Rhode Island, United States

Landmark Hospital

Woonsocket, Rhode Island, United States