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

Официальное название

Klinische Studie Zur Untersuchung Und Validierung Eines Therapieverfahrens Zur Einstellung Von Risikofaktoren Bei Patienten Mit Koronarer Herzkrankheit (KHK) Mittels Digitaler Therapiesteuerung

Обзор

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).

Подробное описание

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.

Вмешательства

• Устройство 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 th

Первичные конечные точки

• Proportion of patients in target range of LDL or blood pressure [Срок оценки: 9 months]

Вторичные конечные точки (12)

• Absolute LDL reduction after 9 months in patients with known LDL levels at inclusion (not older than 12 months at study inclusion) and no medication adjustment within the last 12 months prior to study inclusion. [Срок оценки: 9 months]
• Assessment of stability: Comparison of LDL levels after 18 months in patients with known LDL levels [Срок оценки: 18 months]
• Assessment of stability: Comparison of blood pressure after 18 months [Срок оценки: 18 months]
• In patients with diabetes: target blood HbA1c level of ≤ 7% or ≤ 53mmol/mol after 9 months. [Срок оценки: 9 months]
• Assessment of stability in patients with diabetes: Comparison of blood HbA1c levels after 18 months. [Срок оценки: 18 months]
• In patients with diabetes: absolute reduction in blood HbA1c level after 9 months. [Срок оценки: 9 months]
• In patients with obesity: absolute BMI reduction after 9 months. [Срок оценки: 9 months]
• Assessment of stability in patients with obesity: Comparison of BMI changes after 18 months. [Срок оценки: 18 months]
• Absolute BMI reduction in patients with initial BMI > 30kg/m2 after 9 months. [Срок оценки: 9 months]
• In patients with obesity: percentage reduction in body mass index (BMI) after 9 months, which should fall within the target range below 25 kg/m2 as best as possible according to guideline recommendations. [Срок оценки: 9 months]
• For patients with current nicotine abuse: determination of/review of smoking cessation after 9 months. [Срок оценки: 9 months]
• Assessment of stability for patients with current nicotine abuse: determination of/review of smoking cessation after 18 months. [Срок оценки: 18 months]

Критерии участия

Критерии включения

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

• inpatient stay with acute STEMI/NSTEMI or historic STEMI/NSTEMI; and/or
• 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

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Германия · 1 центр

• Klinikum der Ludwig-Maximilians-Universität München (Klinikum der Universität München), Me — Munich

Идентификаторы

NCT: NCT06091774 · 03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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