NCT05580068

Investigation and Validation of a Study Project on Digital Therapy Management of Patients With Arterial Hypertension

Pilot-Studie Zur Explorativen Untersuchung Und Validierung Eines Studienvorhabens Zur Digitalen Therapiesteuerung Von Patienten Mit Arterieller Hypertonie im Vergleich Der Behandlung Mit Dem Standard-of-Care - iATROS eXPLORE

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: iATROS GmbH · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this pilot study is to exploratively test the basic feasibility of a clinical trial for the controlled investigation of the efficacy and effectiveness of iATROS digital therapy management in the treatment of patients with arterial hypertension within the framework of a clinical trial. In addition, the results of the treatment will be used to generate an initial data basis for the effectiveness of treatment with iATROS.

Detailed description

The aim of this pilot project is to form the basis for testing the iATROS platform in an controlled setting of a clinical study, in particular to collect data for a more precise determination of the sample size including the investigation of dropout rates, to investigate the acceptance of study-related measures, and to test and better prepare the procedures for the successful implementation of study-related measures. Furthermore, the first data for testing the effectiveness of the iATROS solution for the treatment of hypertensive patients will be collected. For this purpose, health data as well as data points on health literacy and patient sovereignty will be collected from the patients in the pilot study.

Conditions

• Cardiovascular Diseases
• Hypertension

Interventions

Type	Name	Description
DEVICE	Hypertension therapy through iATROS medical device	The intervention to be carried out in the treatment group is the use of the therapy support provided by the iATROS medical device for the treatment of arterial hypertension. In particular, patients are guided through a structured digital therapy program that enables them to better manage their disease. Patient receive reminders for taking their medication, for performing vital parameter measurements, and receive educational content for them to learn how to manage their disease better.

Timeline

• Start date: 2022-11-10
• Primary completion: 2024-10-01
• Completion: 2024-10-01
• First posted: 2022-10-14
• Last updated: 2024-03-06

Locations

1 site across 1 country: Germany