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

NCT ID: NCT05580068

Last Updated: 2024-03-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-10
• Study Completion Date: 2024-10-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Group

The intervention to be carried out in the treatment group is the use of the therapy measures for the treatment of arterial hypertension, which is delivered through the iATROS medical device. The therapy by means of the medical device takes place over 90 days.

Group Type: EXPERIMENTAL

Hypertension therapy through iATROS medical device

Intervention Type: 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.

Control Group

For the duration of the in-life phase, the treatment of the control group will follow the standard-of-care except for the measures necessary for the conduct of the study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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 blood pressure measurement or, alternatively, at-home blood pressure measurement at ≥135 mmHg systolic (mean of 7 days). In case of the presence of a 24-h blood pressure measurement, 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 to use and apply the iATROS app

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, or generally 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 >175mmHg systolic (mean value of the 7 days). In case of a 24h blood pressure measurement, this value 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, the measures to be performed, a distortion of the results, or the status of a treatment according to the current standard of care result from the participation.
• Comorbidities or the presence of any other physical condition that would prohibit the use of the ESC Hypertension Guideline of 2018 as target blood pressure (i.e. if, due to the patient's individual situation, a different value should be given as a target value 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

iATROS GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stefan Brunner, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Munich, Bavaria, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Paul Weyh

Role: CONTACT

paul.weyh@i-atros.com

+49 176 856 23 142

Georges von Degenfeld, Dr. med.

Role: CONTACT

georges.degenfeld@i-atros.com

+49 89 - 95879243

Facility Contacts

Stefan Brunner, Prof. Dr.

Role: primary

Stefan.Brunner@med.uni-muenchen.de

Monika Baylacher

Role: backup

monika.baylacher@med.uni-muenchen.de

+49 89 4400 57670

References

Schlichtiger J, Struven A, Massberg S, von Degenfeld G, Leber A, Weyh P, Meyer J, Brunner S, Stremmel C. Evaluation of a digital therapy programme for the treatment of primary arterial hypertension: eXPLORE - study protocol for a fully decentralised randomised controlled feasibility study. BMJ Open. 2024 Sep 5;14(9):e081347. doi: 10.1136/bmjopen-2023-081347.

Reference Type: DERIVED

PMID: 39237273 (View on PubMed)

Other Identifiers

02

Identifier Type: -

Identifier Source: org_study_id