Assessment of Efficacy and Safety of Amicomed®, for the Management of Essential Hypertension

NANot yet recruitingINTERVENTIONAL
Enrollment

316

Participants

Timeline

Start Date

November 1, 2024

Primary Completion Date

July 31, 2025

Study Completion Date

October 31, 2025

Conditions
Essential HypertensionPrimary Hypertension
Interventions
DEVICE

Amicomed®

This app helps users track their blood pressure readings over time with analysis and history features. It generates graphs and charts to display trends and patterns, and users can set reminders to take blood pressure readings. Additionally, the app offers personalized recommendations for lifestyle, including personalized diet plans, and physical exercise programs based on the user's information. Using cognitive-behavioral techniques and motivational levers, the app helps users overcome barriers to lifestyle changes and provides personalized feedback and coaching. It also includes a database of evidence-based strategies for behavior change, and users can receive notifications, reminders, and rewards to stay motivated.

DEVICE

Digital Placebo

Subjects will be provided with a white label mobile app, which allows to (1) add blood pressure measurements, (2) access the history of recorded measurements. No notification system will be implemented.

OTHER

Usual Care

Usual Care (UC): Subjects assigned to control group will receive care as usual care, including self-monitoring indications.

All Listed Sponsors
lead

Newel Health SRL

INDUSTRY

NCT06091176 - Assessment of Efficacy and Safety of Amicomed®, for the Management of Essential Hypertension | Biotech Hunter | Biotech Hunter