Digital therapy management for patients with high blood pressure

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

This study is testing a digital therapy program to see if it can help people with high blood pressure manage their condition better and if they like using it.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: iATROS GmbH (industry)
• Locations: 1 site (Munich, Bavaria)
• Trial ID: NCT05580068 on ClinicalTrials.gov

What this trial studies

This pilot project aims to explore the feasibility of using the iATROS digital therapy management platform for treating patients with arterial hypertension. The study will collect health data and assess patient acceptance of the treatment measures while preparing for a larger controlled clinical trial. It will also gather initial data on the effectiveness of the iATROS solution in managing hypertension. The focus is on understanding dropout rates and refining procedures for future studies.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of arterial hypertension and the ability to use a smartphone.

Not a fit: Patients who do not own or cannot use a smartphone or those with severe cognitive impairments may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the management of arterial hypertension through innovative digital solutions.

How similar studies have performed: While this approach is innovative, similar digital health interventions have shown promise in managing chronic conditions, suggesting potential for success.

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

Where this trial is running

Munich, Bavaria

• Medizinische Klinik und Poliklinik 1, Ludwig-Maximilians-University of Munich — Munich, Bavaria, Germany (RECRUITING)

Study contacts

• Principal investigator: Stefan Brunner, Prof. Dr. — Medizinische Klinik und Poliklinik 1, Ludwig-Maximilians-University of Munich
• Study coordinator: Paul Weyh

Conditions: Cardiovascular Diseases, Hypertension, eHealth, cardiology, hypertension