Rhode Island - Statewide Postpartum Hypertension Remote Surveillance
Recruiting · NCT06842875 · Interventional (participants receive a specific treatment) · Lead sponsor: Women and Infants Hospital of Rhode Island
View the official record on ClinicalTrials.gov →Interventions studied
RI-SPHERESStandard self-measured blood pressure program
What this trial is about
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.
Who can take part
Age range
18 Years to 60 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
Where it is running
5 locations listed across 1 US state.
- 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