Cardiovascular DiseaseseXPLORENCT05580068
Investigation and Validation of a Study Project on Digital Therapy Management of Patients With Arterial Hypertension
A study testing Hypertension therapy through iATROS medical device in people with Cardiovascular Diseases and Hypertension, run by iATROS GmbH at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cardiovascular Diseases, Hypertension
- What is being tested?
- Hypertension therapy through iATROS medical device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 10 Nov 2022to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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
Show all 18Show fewer
- 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 locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Medizinische Klinik und Poliklinik 1, Ludwig-Maximilians-University of Munich
Munich, Bavaria, 80336
Stefan Brunner, Prof. Dr., Stefan.Brunner@med.uni-muenchen.de
Monika Baylacher, +49 89 4400 57670, monika.baylacher@med.uni-muenchen.de
About this study
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
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.
Read the 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
- Being tested
- Hypertension therapy through iATROS medical device
- Keywords
- eHealth, cardiology, hypertension
- Medical subject headings
- Cardiovascular Diseases, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertension therapy through iATROS medical deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Device: Hypertension therapy through iATROS medical device |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and study completion, an average of 180 days
Secondary outcomes (5)
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 90 days and 180 days after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start10 Nov 2022
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- monocentric randomized controlled study (RCT)
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- iATROS GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stefan Brunner, Prof. Dr., Principal investigator, Medizinische Klinik und Poliklinik 1, Ludwig-Maximilians-University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05580068
- Sponsor's protocol ID
- 02
- Acronym
- eXPLORE
- Status last verified
- Mar 2024
- First submitted
- 11 Oct 2022
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39237273
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05580068
- Acronym / sponsor ID
- eXPLORE / 02
- Conditions
- Cardiovascular Diseases, Hypertension
- Keywords
- eHealth, cardiology, hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- iATROS GmbHIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 14 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- monocentric randomized controlled study (RCT)
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Hypertension therapy through iATROS medical deviceThe 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypertension therapy through iATROS medical deviceThe 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. | Device | Intervention Group |
Primary outcome
Exploratory testing of study-related measures and the use of iATROS.
Time frame: Baseline and study completion, an average of 180 days
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).
5 secondary outcomes
Blood pressure reduction
Time frame: Baseline and 90 days after enrolment
Blood pressure classification
Time frame: Baseline, 90 days, and 180 days after enrolment
Health Literacy Questionnaire (HLQ)
Time frame: Baseline and 90 days after enrolment
Patient Activation Measure (PAM)
Time frame: Baseline and 90 days after enrolment
Blood pressure reduction effect stability
Time frame: 90 days and 180 days after enrolment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Derived from this study: PubMed 39237273Schlichtiger 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Brunner, Prof. Dr. principal investigator
Medizinische Klinik und Poliklinik 1, Ludwig-Maximilians-University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypertension therapy through iATROS medical device in people with Cardiovascular Diseases and Hypertension, run by iATROS GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul Weyh (+49 176 856 23 142, paul.weyh@i-atros.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exploratory testing of study-related measures and the use of iATROS. (time frame: Baseline and study completion, an average of 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05580068, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024; AzTrials last refreshed its copy on 6 Nov 2026.