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

Proportion of patients per study arm in percent with adjusted LDL cholesterol in the blood of < 55 mg/dl (< 1.4 mmol/l) and/or adjusted blood pressure according to ESC guideline (≤130 mmHg systolic or ≤140 mmHg systolic for age > 70 years).

Comparison of the mean value of the absolute reduction between the treatment and control group of this patient population with regard to statistically significant differences.

Furthermore, intra-group comparison of this patient population per study arm to determine statistically significant effects with regard to LDL reduction by treatment with iATROS over 9 months.

Comparison of medical parameter LDL (available through standard-of-care treatment) between the two study arms after 18 months study duration.

Comparison of blood pressure values (available through standard-of-care measurements) between the two study arms after 18 months study duration.

Comparison of the proportion of patients per study arm in percent in the HbA1c target range with regard to statistically significant differences. In addition to an intergroup comparison, an intragroup comparison per study arm will be performed.

Comparison of medical parameter HbA1c (available through standard-of-care treatment) between the two study arms after 18 months study duration.

Comparison of the mean absolute reduction in HbA1 levels between the treatment and control groups for statistically significant differences in patients with history of HbA1c levels at inclusion.

Furthermore, intragroup comparison per study arm to determine, whether treatment with iATROS has a statistically significant effect on the reduction of HbA1c levels over 9 months.

Comparison of the mean value of the absolute BMI reduction and the absolute weight reduction in [kg] with regard to the statistical significance of the absolute change between all patients in the treatment and control group. In addition to an intergroup comparison, an intragroup comparison per study arm will be performed.

Comparison of BMI values (available through standard-of-care measurement of weight and height which will be combined to report BMI in kg/m^2) between the two study arms after 18 months study duration.

Comparison of the mean value of the absolute BMI reduction of this patient collective as well as the mean absolute weight reduction in [kg] with regard to statistical significance of the absolute change between the treatment and the control group. In addition to an intergroup comparison, an intragroup comparison per study arm will be performed.

Comparison of the mean value of the percentage BMI reduction between the treatment and control groups with regard to statistical significance. In addition, a comparison with the predefined target value is to be used to calculate which proportion of the intervention and control groups falls within this target range in [%] before the study period and after 9 months. In addition to an intragroup comparison, an intragroup comparison per study arm will be performed.

Query of smoking status and pack years per patient. Comparison of the percentage per study arm, who no longer define themselves as "smokers" and the percentage of patients who have defined themselves as "ex-smokers" for >6 months. Comparison of study arms and intragroup comparison 9 months after inclusion.

Determination of smoking status using the Fagerström test for nicotine dependence (FTND).

Comparison of Fagerström test for nicotine dependence (FTND) scores between the two study arms after 18 months study duration.

The study will examine whether an improvement in health literacy can be measured after 9 and 18 months when using digital therapy management via iATROS. The Rasch-scaled short form of the European Health Literacy Survey (HLS-EU-Q16) questionnaire comprises 16 questions that are rated on a 4-level scale, with the answer options focussing on the respective difficulty (very easy, fairly easy, fairly difficult, very difficult). The four answer options are dichotomised, whereby the two categories "very easy" and "fairly easy" were assigned a value of 1 and the two remaining categories a value of 0. Based on the sums achieved, the health literacy of the patients is finally categorised as "insufficient" (sum 0-8), "problematic" (sum 9-12) and "sufficient" (sum 13-16).Since the questionnaires are submitted in the treatment group and the control group both at baseline and after 9 and 18 months, respectively, an intra-group comparison as well as an inter-group comparison is possible.

Comparison of the European Health Literacy Survey (HLS-EU-Q16) scores between the two study arms after 18 months study duration.

The study will examine whether the use of iATROS results in an increase in patient sovereignty after the treatment period of 9 and also 18 months. In order to measure this, a short-form of the Patient Activation Measure (PAM-13) will be used. The results are divided into different categories by quantitatively evaluating the results of the questions answered in a four-point Likert scale (not true, hardly true, rather true, exactly true). The total score results from the answers to the individual questions after standardization and is divided into four levels: Level 1 (lack of belief that activation is important, ≤47 points), Level 2 (lack of knowledge and confidence to take action, 47.1-55.1 points), Level 3 (beginning to take action, 55.2-67.0 points) and Level 4 (taking action, ≥67 points). The measurement of PAM-13 at the beginning of the study and after 9 and 18 months allows an intragroup and intergroup comparison.

Comparison of the Patient Activation Measure (PAM-13) scores between the two study arms after 18 months study duration.