NCT06091176

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

A Multicenter, Randomized, Parallel-Group, Single-Blind Study to Compare the Efficacy and Safety of Amicomed®, for the Management of Essential Hypertension

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 316 (estimated)
• Sponsor: Newel Health SRL · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, single-blind, parallel-group study to evaluate the efficacy and safety of Amicomed® compared with Usual Care (UC) over a 24-week treatment period in subjects with essential hypertension (mean, home based systolic blood pressure (SBP) ≥ 140 and/or diastolic blood pressure DBP ≥ 90 mm Hg on Day 1).

Detailed description

Amicomed is a Digital therapeutics service and program for BP management and reduction. The key features of Amicomed include: 1. an automatic, expert system based, finite-machine AI algorithm for assessing the evolution of blood pressure levels, 2. an automatic, expert system based, finite-machine AI algorithm for generating and delivering a detailed lifestyle program (dietary and physical activity) starting from the general lifestyle suggestions of the hypertension and cardiovascular prevention guidelines and producing a truly personalized program. 3. a behavioral strategy embedded into the app to increase adherence and persistence into the program. The Amicomed Digital Therapeutics Service and App for hypertension management and intervention has been shown to significantly improve BP levels in case-control studies .These initial results demonstrated a 5mmHg systolic BP reduction across all Amicomed subscribers and 7.9 mmHg systolic BP reduction in subject with \>= stage 1 hypertension. Comparable reduction of diastolic BP was also achieved. The aim of this study is to investigate the long-term efficacy of the Amicomed® Digital Therapeutics Program, compared to Usual Care, in reducing Systolic and Diastolic Blood Pressure in subjects with primary hypertension.

Conditions

• Essential Hypertension
• Primary Hypertension

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-11-01
• Primary completion: 2025-07-31
• Completion: 2025-10-31
• First posted: 2023-10-19
• Last updated: 2023-10-23