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

NCT05580068 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-03-06

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • iATROS GmbH

    lead INDUSTRY

Principal Investigators

  • Stefan Brunner, Prof. Dr. · Medizinische Klinik und Poliklinik 1, Ludwig-Maximilians-University of Munich

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-10
Primary Completion
2024-10-31
Completion
2024-10-31

Countries

  • Germany

Study Locations

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Entities

Diseases

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 NCT05580068 on ClinicalTrials.gov