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

iATROS

Status: Enrolling

Conditions: Hypertension; Cardiovascular Diseases

Treatments: Device: Hypertension therapy through iATROS medical device

Study type: Interventional

Funder types: Industry

Identifiers

NCT05580068

02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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.

Treatment:

Device: Hypertension therapy through iATROS medical device

Control Group

No Intervention group

Description:

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.