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

NCT ID: NCT06091176

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 316 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-10-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm 1

Subjects assigned to ID1 treatment arm will receive Amicomed® for 90 days, together with Usual Care (UC) procedures.

Group Type: EXPERIMENTAL

Amicomed®

Intervention Type: DEVICE

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.

Usual Care

Intervention Type: OTHER

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

Arm 2

Subjects assigned to ID2 treatment arm, will receive a digital Placebo, together with UC for 90 days.

Group Type: PLACEBO_COMPARATOR

Digital Placebo

Intervention Type: DEVICE

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.

Usual Care

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Usual Care

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Male or female with age ≥ 18 years
• Diagnosed with essential hypertension and exhibiting a mean home-based SBP ≥ 140 and/or DBP > 90mm Hg, i.e., Grade I Hypertension .
• Disease duration: 12 (+/-) 3 months
• Unmedicated, or currently treated by a stable regimen for hypertension with sub-optimal response to usual care treatments (Delta SBP < 5 mm Hg; and/or Delta DBP < 5 mm Hg)
• Not participating in physical exercise or dietary programs during the last 12 months from Visit 1.
• Willing and able to return for all clinic visits and to complete all study-required procedures
• Able to use the app, [self-report compliance over 80%]. Compliance is defined as the capacity to provide at least 6 BP measurements per week during the beginning, middle and end week of the 24 weeks program.

Exclusion Criteria

• Pregnancy or planning to become pregnant during the study period
• Use of medications that may interfere with the study intervention
• Severe kidney or liver disease
• Active cancer treatment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Newel Health SRL

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Domenico Cianflone, MD, PhD

Role: STUDY_CHAIR

Newel Health SRL

Central Contacts

Giovanni Gentile, MSc

Role: CONTACT

giovanni.gentile@newel.health

+393282438545

Other Identifiers

NWL-AMD-CS-001

Identifier Type: -

Identifier Source: org_study_id