NCT06091774

Clinical Study for the Investigation and Validation of a Therapy Procedure for the Adjustment of Risk Factors in Patients With Coronary Heart Disease by Means of Digital Therapy Control

Klinische Studie Zur Untersuchung Und Validierung Eines Therapieverfahrens Zur Einstellung Von Risikofaktoren Bei Patienten Mit Koronarer Herzkrankheit (KHK) Mittels Digitaler Therapiesteuerung

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: iATROS GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will test a controlled investigation of the efficacy and effectiveness of iATROS digital therapy management for risk factor adjustment in patients with coronary heart disease (CHD).

Detailed description

The purpose of this study is to determine the efficacy and effectiveness of iATROS digital therapy management for risk factor adjustment in patients with coronary heart disease compared to the medical standard of care. In addition, data will be provided to investigate the functionality of the rule engine in the treatment of CHD patients and insights will be gained for the further development of this component of the iATROS platform for the digital and intelligent treatment of patients. Furthermore, the use of digital everyday products (smartphones) in secondary prevention and therapy management of CHD patients will be considered.

Conditions

• Coronary Artery Disease
• Cardiovascular Diseases
• Coronary Heart Disease
• Ischemic Heart Disease

Interventions

Type	Name	Description
DEVICE	CHD therapy through iATROS medical device	The intervention to be carried out in the treatment group is the use of the therapy control for the treatment of CHD played out via the iATROS medicine product. Patients will receive a suitable and medical device certified measuring device for recording vital parameters. The iATROS app is downloaded to the patient's smartphone and the app is activated by entering a code that identifies the user as a participant in the study. When using the app for the first time, the patient is guided through the first steps of using the app and asked to transfer his or her health data to the app. The therapy control by means of the medication product takes place over the entire duration of the study.

Timeline

• Start date: 2023-10-05
• Primary completion: 2025-04-01
• Completion: 2026-10-01
• First posted: 2023-10-19
• Last updated: 2024-03-06

Locations

1 site across 1 country: Germany