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

NCT06091176 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 316

Last updated 2023-10-23

No results posted yet for this study

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).

Conditions

  • Essential Hypertension
  • Primary 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.

Sponsors & Collaborators

  • Newel Health SRL

    lead INDUSTRY

Principal Investigators

  • Domenico Cianflone, MD, PhD · Newel Health SRL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2025-07-31
Completion
2025-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06091176 on ClinicalTrials.gov