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

Last updated: March 5, 2024
Sponsor: iATROS GmbH
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stress

Circulation Disorders

Williams Syndrome

Treatment

Hypertension therapy through iATROS medical device

Clinical Study ID

NCT05580068
02
  • Ages 18-100
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ≥ 18 years of age
  • Existing diagnosis of arterial hypertension according to ICD-10 I10.- to I13.-, i.e.presence of the disease is recorded at the time of inclusion in the study.
  • Blood pressure at the time of inclusion is ≥130 mmHg systolic (24h mean) at 24h bloodpressure measurement or, alternatively, at-home blood pressure measurement at ≥135mmHg systolic (mean of 7 days). In case of the presence of a 24-h blood pressuremeasurement, this value is decisive compared to the at-home measurement.
  • Possession and use of a smartphone that allows the installation and use of "iATROS",whereby "use" implies that the patient possesses the physical and mental abilities touse and apply the iATROS app

Exclusion

Exclusion Criteria:

  • Lack of capacity to consent
  • < 18 years of age
  • No use of a smartphone
  • Lack of the physical and mental abilities necessary to use the iATROS app, orgenerally to use so-called "apps" on a smartphone or tablet.
  • Tumor disease associated with a reduced life expectancy of less than 1 year
  • Immunosuppression
  • Advanced dementia
  • Any other disease associated with a reduced life expectancy of less than 1 year
  • Any disease/condition that limits participation in the program
  • Pregnant or breastfeeding patients
  • A secondary hypertension known to the patient (by history)
  • Blood pressure at inclusion is >170mmHg systolic on 24h blood pressure measurement (24h mean) or, alternatively, the at-home blood pressure measurement is >175mmHgsystolic (mean value of the 7 days). In case of a 24h blood pressure measurement, thisvalue is decisive compared to the at-home measurement.
  • Existing participation and enrollment in the iATROS hypertension health program.
  • Participation in another clinical trial, if complications with compliance, themeasures to be performed, a distortion of the results, or the status of a treatmentaccording to the current standard of care result from the participation.
  • Comorbidities or the presence of any other physical condition that would prohibit theuse of the ESC Hypertension Guideline of 2018 as target blood pressure (i.e. if, dueto the patient's individual situation, a different value should be given as a targetvalue for a blood pressure value to be classified as healthy).
  • Addictions
  • Stroke in the last 3 months
  • Transient ischemic attack (TIA) in the last 3 months

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Hypertension therapy through iATROS medical device
Phase:
Study Start date:
November 10, 2022
Estimated Completion Date:
October 31, 2024

Study 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.

Connect with a study center

  • Medizinische Klinik und Poliklinik 1, Ludwig-Maximilians-University of Munich

    Munich, Bavaria 80336
    Germany

    Active - Recruiting

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