Investigation and Validation of a Study Project on Digital Therapy Management of Patients With Ar… (NCT05580068) | Clinical Trial Compass
UnknownNot Applicable
Investigation and Validation of a Study Project on Digital Therapy Management of Patients With Arterial Hypertension
Germany100 participantsStarted 2022-11-10
Plain-language 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.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Exploratory testing of study-related measures and the use of iATROS.
Timeframe: Baseline and study completion, an average of 180 days