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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Hypertension
• Intervention / Treatment: Device: Hypertension therapy through iATROS medical device

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paul Weyh; Phone Number: +49 176 856 23 142; Email: paul.weyh@i-atros.com
• Study Contact Backup: Name: Georges von Degenfeld, Dr. med.; Phone Number: +49 89 - 95879243; Email: georges.degenfeld@i-atros.com

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 80336
      • Recruiting
      • Medizinische Klinik und Poliklinik 1, Ludwig-Maximilians-University of Munich
      • Contact: Monika Baylacher; Phone Number: +49 89 4400 57670; Email: monika.baylacher@med.uni-muenchen.de
      • Contact: Stefan Brunner, Prof. Dr.; Email: Stefan.Brunner@med.uni-muenchen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory testing of study-related measures and the use of iATROS.	Determination of subjective burden perception of the study-related measures using the Study Participant Feedback Questionnaire (SPFQ) - Questionnaire. The three subscales (A-C) are administered at three discrete time points, immediately after enrolment, after half the in-live phase time has passed and at the last visit in the study center. The questions are answered on a 5-point scale with a higher level indicating a higher satisfaction with the study-related measures. Possible levels are 0 to 24 (subscale A), 0 to 39 (subscale B) and 0 to 14 (subscale C).	Baseline and study completion, an average of 180 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure reduction	Measurement of blood pressure in mmHg after 90 days of treatment as compared to baseline. Comparison of the mean absolute reduction in systolic blood pressure in intragroup analysis per study arm and between treatment arms (intervention vs. control).	Baseline and 90 days after enrolment
Blood pressure classification	Assessment of the fraction of patients in [%] with a blood pressure classified as "healthy" as per the definition outlined in the "2018 ESC/ESH Clinical Practice Guidelines for the Management of Arterial Hypertension " after 90 days of treatment and at follow-up at 180 days as compared to baseline. Comparison of the mean absolute reduction in systolic blood pressure in intragroup analysis per study arm and between treatment arms (intervention vs. control).	Baseline, 90 days, and 180 days after enrolment
Health Literacy Questionnaire (HLQ)	Administration of the Health Literacy Questionnaire (HLQ) to assess disease-related health literacy. The questionnaire is comprised of 9 subscales. Scale 1-5 are graded on a 4-point scale (possible levels per subscale 1 to 4), scale 6-9 are graded on a 5-point scale (possible levels per subscale 1 to 5) with higher levels showing higher health literacy. Measurement at baseline and at the end of a 90-day treatment period. Assessment of changes in health literacy in intra-group comparison per study arm and inter-group comparison.	Baseline and 90 days after enrolment
Patient Activation Measure (PAM)	Measurement of degree of patient activation via the Patient Activation Measure (PAM) questionnaire. Measurement at baseline and at the end of a 90-day treatment period. Assessment of changes in health literacy in intra-group comparison per study arm and inter-group comparison. Possible levels 0 to 100, with a higher level indicating higher activation.	Baseline and 90 days after enrolment
Blood pressure reduction effect stability	Measurement of blood pressure level in mmHg 90 days after finishing in-live phase and comparison to blood pressure level 90 days after enrolment. Comparison of the mean absolute reduction in systolic blood pressure in intragroup analysis per study arm and between treatment arms (intervention vs. control).	90 days and 180 days after enrolment

Collaborators and Investigators

• Sponsor: iATROS GmbH
• Investigators: Principal Investigator: Stefan Brunner, Prof. Dr., Medizinische Klinik und Poliklinik 1, Ludwig-Maximilians-University of Munich

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2022
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: October 11, 2022
• First Submitted That Met QC Criteria: October 11, 2022
• First Posted (Actual): October 14, 2022

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: hypertension; eHealth; cardiology
• Additional Relevant MeSH Terms: Vascular Diseases; Hypertension; Cardiovascular Diseases
• Other Study ID Numbers: 02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No