Clinical Study for the Investigation and Validation of a Therapy Procedure for the Adjustment of Risk Factors in Patients With Coronary Heart Disease by Means of Digital Therapy Control

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-05

Study Completion Date

2026-10-31

Brief Summary

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This study will test a controlled investigation of the efficacy and effectiveness of iATROS digital therapy management for risk factor adjustment in patients with coronary heart disease (CHD).

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Detailed Description

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The purpose of this study is to determine the efficacy and effectiveness of iATROS digital therapy management for risk factor adjustment in patients with coronary heart disease compared to the medical standard of care.

In addition, data will be provided to investigate the functionality of the rule engine in the treatment of CHD patients and insights will be gained for the further development of this component of the iATROS platform for the digital and intelligent treatment of patients.

Furthermore, the use of digital everyday products (smartphones) in secondary prevention and therapy management of CHD patients will be considered.

Conditions

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Coronary Artery Disease Cardiovascular Diseases Coronary Heart Disease Ischemic Heart Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group with the medical device "iATROS"

Patients are subsequently assigned to one of the two groups in a 1:1 randomization.

The treatment to be carried out in the intervention group is the use of the therapy control for the treatment of CHD, which is played out via the iATROS medical device. At the start of the digital treatment, the patients receive suitable measuring devices for recording their vital parameters in the home environment. With the completion of the visit in month 9, the active phase of the study has ended. Patients will now use the iATROS medical device for another 9 months, after which the stability of the intervention effects will be determined.

CHD therapy through iATROS medical device

Intervention Type DEVICE

The intervention to be carried out in the treatment group is the use of the therapy control for the treatment of CHD played out via the iATROS medicine product. Patients will receive a suitable and medical device certified measuring device for recording vital parameters. The iATROS app is downloaded to the patient's smartphone and the app is activated by entering a code that identifies the user as a participant in the study. When using the app for the first time, the patient is guided through the first steps of using the app and asked to transfer his or her health data to the app. The therapy control by means of the medication product takes place over the entire duration of the study.

Group without the medical device "iATROS"

All patients in the control group will receive standard-of-care treatment in the 9 months after randomization. There will be no further intervention during this phase. Similarly, treatment is not influenced or restricted in terms of free choice of medical care or medical treatment.

Subsequently, they also receive access to the iATROS medical device. Patients will receive suitable measuring devices for recording their vital parameters in the home environment. The effects of the intervention will be recorded after 9 months.

No interventions assigned to this group

Interventions

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CHD therapy through iATROS medical device

The intervention to be carried out in the treatment group is the use of the therapy control for the treatment of CHD played out via the iATROS medicine product. Patients will receive a suitable and medical device certified measuring device for recording vital parameters. The iATROS app is downloaded to the patient's smartphone and the app is activated by entering a code that identifies the user as a participant in the study. When using the app for the first time, the patient is guided through the first steps of using the app and asked to transfer his or her health data to the app. The therapy control by means of the medication product takes place over the entire duration of the study.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* ≥ 18 years
* Patients diagnosed with ischemic heart disease according to ICD I20 to I25 who also have at least one of the following:

1. inpatient stay with acute STEMI/NSTEMI or historic STEMI/NSTEMI; and/or
2. Coronary stent implantation, angioplasty or bypass surgery that has taken place.
* Ownership and use of a smartphone that allows installation and use of "iATROS," where "use" requires having the physical and mental ability to use and apply the iATROS app.
* Insured with the cooperating insurances

Exclusion Criteria

* No use of a smartphone
* Lack of the linguistic, physical and mental abilities necessary to use the iATROS app, or to use so-called "apps" on a smartphone or tablet in general.
* Absolute contraindications: Any disease associated with a reduced life expectancy of less than 2 years; Any disease/condition that limits participation in the program; Pregnant or breast feeding patients; Patients with advanced dementia
* Existing participation and enrollment in an iATROS health program.
* Participation in another clinical trial if participation results in complications with compliance, measures to be performed, bias of results, or status of treatment according to the current standard of care.
* Comorbidities or the presence of another physical condition that complicates the setting of the clinical target parameters sought in the study (i.e., if, due to the patient's individual situation, a different value would have to be issued as the target value for a clinical parameter to be classified as healthy).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No