What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Health literacy-informed patient education materials, BP monitor, brief orientation, and portal tools, or The MeDS assessment. The registry lists allocation as randomized. Test the effectiveness of a technology-enabled strategy to optimize blood pressure among reproductive-aged women with hypertension receiving care in Federally Qualified Health Centers.
They plan to enroll about 350 people at Chicago. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.
Official title (unrewritten)
A Technology-based, Primary Care Strategy to Optimize Blood Pressure Before Pregnancy: The REACH-OUT Trial
Interventions: Health literacy-informed patient education materials, BP monitor, brief orientation, and portal tools, The MeDS assessment, Patient navigator support
Primary outcome (registry wording): Systolic blood pressure