Rhode Island - Statewide Postpartum Hypertension Remote Surveillance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorWomen and Infants Hospital of Rhode Island
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- RI-SPHERES
- Standard self-measured blood pressure program
Treatment groups
1,536 Participants
are divided into 2 treatment groupsSponsors and collaborators
Women and Infants Hospital of Rhode Island
Lead sponsor
Brown University
Collaborator
Kent Hospital, Rhode Island
Collaborator
Source ClinicalTrials.gov