RecruitingNot ApplicableNCT06842875

Rhode Island - Statewide Postpartum Hypertension Remote Surveillance

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

Sponsor

Women and Infants Hospital of Rhode Island

Enrollment

1,536 participants

Start Date

Apr 15, 2025

Study Type

INTERVENTIONAL

Conditions

Postpartum Complication Hypertension in Pregnancy Postpartum Preeclampsia

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

Sex: FEMALEMin Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a remote monitoring program to help manage high blood pressure after childbirth in people who had pregnancy-related hypertension. **You may be eligible if...** - You are 18 or older and gave birth at a Rhode Island hospital - You were diagnosed with a hypertensive disorder during or after pregnancy - You speak English, Spanish, Portuguese, or Haitian Creole - You own a smartphone **You may NOT be eligible if...** - You have already been enrolled in this study before - You are incarcerated - You are unable or unwilling to provide informed consent - You cannot communicate with the study team, even with an interpreter Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALRI-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.

BEHAVIORALStandard 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.