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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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

Locations
United States
Rhode Island
Newport Hospital
NOT_YET_RECRUITING
Newport
Women & Infants Hospital of Rhode Island
RECRUITING
Providence
South County Hospital
NOT_YET_RECRUITING
Wakefield
Kent Hospital
RECRUITING
Warwick
Landmark Hospital
RECRUITING
Woonsocket
Contact Information
Primary
Stephanie Nunez, Research Coordinator
snunez@wihri.org
401-274-1122
Time Frame
Start Date: 2025-04-15
Estimated Completion Date: 2029-03-01
Participants
Target number of participants: 1536
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Women and Infants Hospital of Rhode Island
Collaborators: Brown University, Kent Hospital, Rhode Island

This content was sourced from clinicaltrials.gov