Clinical trial NCT05580068: Investigation and Validation of a Study Project on Digital Therapy Management of Patients With Arterial Hypertension
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Hypertension
Keywords: eHealth
cardiology
hypertension
Lead sponsor: iATROS GmbH
Sponsor class: INDUSTRY
First posted: 2022-10-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: monocentric randomized controlled study (RCT)
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Exploratory testing of study-related measures and the use of iATROS.
timeFrame: Baseline and study completion, an average of 180 days
Secondary outcomes:
measure: Blood pressure reduction
timeFrame: Baseline and 90 days after enrolment
measure: Blood pressure classification
timeFrame: Baseline, 90 days, and 180 days after enrolment
measure: Health Literacy Questionnaire (HLQ)
timeFrame: Baseline and 90 days after enrolment
measure: Patient Activation Measure (PAM)
timeFrame: Baseline and 90 days after enrolment
measure: Blood pressure reduction effect stability
timeFrame: 90 days and 180 days after enrolment
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Medizinische Klinik und Poliklinik 1, Ludwig-Maximilians-University of Munich
state: Bavaria
Study officials:
affiliation: Medizinische Klinik und Poliklinik 1, Ludwig-Maximilians-University of Munich
name: Stefan Brunner, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: