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Not yet recruiting Not applicable NCT07540143

The REACH-OUT Trial

No applicable phase (e.g. observational)
Conditions: Hypertension Reproductive Behavior Primary Health Care Electronic Health Record

Sponsor: Northwestern University

trial.available_in: БГ
Overview
We will 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.
Description
Our team has worked with our FQHC partners to co-develop a multicomponent, technology-based strategy to promote the REproductive And Cardiovascular Health Of Underserved Patients with HyperTension (REACH-OUT). Clinicians at participating study sites will receive EHR-based clinical decision support that facilitates review of prescribed antihypertensives (antiHTNs) and contraceptives to identify contraindications and prompts targeted counseling on medication safety, adherence, and BP for young women with hypertension (HTN). For patients in the intervention arm, REACH-OUT also provides \[1\] educational materials to reinforce clinician counseling, \[2\] a BP monitor, training, and access to a patient portal-based tool where home BP measures can be recorded, and \[3\] a brief, portal-based survey to assess antiHTN use and 'phenotype' causes of poor adherence for clinic review. For patients who have difficulty monitoring their BP and adherence at home, \[4\] a patient navigator will provide tailored support and help troubleshoot any challenges. We will test REACH-OUT vs. usual care in a patient-randomized trial. We will enroll 350 English or Spanish-speaking, non-pregnant women on antiHTN therapy with elevated BP. Our aims are to: 1) Test the effectiveness of REACH-OUT, compared to usual care, to lower systolic BP, improve antiHTN adherence, and reduce use of contraindicated medications within 3 months; 2) Assess the reach, adoption, implementation, maintenance, and costs of REACH-OUT components; and 3) Explore the dose-response effect of REACH-OUT on BP, antiHTN adherence, and use of contraindicated medications over 12 months.
Who can participate
Inclusion Criteria: * biologically female * age 18-44 * English or Spanish-speaking * prescribed an antiHTN * have a systolic BP \>140 or diastolic BP\>90 at their index visit * have access to the internet Exclusion Criteria: * not pregnant or within 3 months postpartum * severe, uncorrectable vision, hearing, or cognitive impairment that would preclude study consent or participation
Interventions
Health literacy-informed patient education materials
OTHER
BP monitor, brief orientation, and portal tools
BEHAVIORAL
The MeDS assessment
OTHER
Patient navigator support
OTHER
Locations

Location information is not available.

Technical details
Status
Not yet recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Female only
Minimum age
18 Years
Maximum age
44 Years
Healthy volunteers
No
Start date
01.05.2026
Completion date
30.06.2030
Registry ID
NCT07540143
Source
clinicaltrials.gov
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