A Two-arm Parallel Randomized Clinical Trial of Implementation of Technology-enabled Management Versus Usual Care for Blood Pressure
Stanford University
Summary
Two arm parallel randomized clinical trial
Description
For this study, we have 3 cohorts that employ varying recruitment strategies before they are enrolled in the interventions. At Stanford, we have 2 cohorts, where Cohort 1 is recruiting participants through clinic screening and contacting them through text or email. For Cohort 2, recruitment is divided into two phases: Control Phase I and Intervention Phase II. During Control Phase I, standard recruitment methods were employed, including general outreach through participating clinics and pre-existing clinical networks. These efforts did not incorporate specific strategies aimed at enhancing d…
Eligibility
- Age range
- 30–90 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age 30-90 yrs. * Smartphone ownership * Office SBP: ≥ 140 mm Hg * ≤ 2 current anti-HTN meds * Able to add or dose-increase at least 2 of the following classes of medications: ACE-I/ARB, diuretic, calcium channel blocker, beta-blocker, mineralocorticoid receptor antagonists (i.e., at least 2 classes are available for addition or dose- increases after excluding intolerant medications and medications currently at maximum dose) * English or Spanish-speakers Exclusion Criteria: * Heart failure with reduced ejection fraction (EF \< 40%) * ESRD (GFR \<15) * Renal replacement…
Interventions
- OtherDigital Hypertension Management System
Mobile health technology using physician- directed, semi-automated management of hypertension
- OtherUsual Care
The participants will receive usual care
Locations (3)
- Stanford Health CarePalo Alto, California
- Morehouse School of MedicineAtlanta, Georgia
- Lake Country Medical GroupEatonton, Georgia