Klinische Studie Zur Untersuchung Und Validierung Eines Therapieverfahrens Zur Einstellung Von Risikofaktoren Bei Patienten Mit Koronarer Herzkrankheit (KHK) Mittels Digitaler Therapiesteuerung
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- iATROS GmbH
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Proportion of patients in target range of LDL or blood pressure
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 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
排除标准
- •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).
结局指标
主要结局
Proportion of patients in target range of LDL or blood pressure
时间窗: 9 months
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).
次要结局
- Assessment of stability in patients with obesity: Comparison of BMI changes after 18 months.(18 months)
- Assessment of stability: Comparison of LDL levels after 18 months in patients with known LDL levels(18 months)
- In patients with diabetes: absolute reduction in blood HbA1c level after 9 months.(9 months)
- Absolute BMI reduction in patients with initial BMI > 30kg/m2 after 9 months.(9 months)
- 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.(9 months)
- Assessment of stability: Comparison of blood pressure after 18 months(18 months)
- In patients with diabetes: target blood HbA1c level of ≤ 7% or ≤ 53mmol/mol after 9 months.(9 months)
- In patients with obesity: absolute BMI reduction after 9 months.(9 months)
- Improving health literacy(9 months and 18 months)
- Assessment of stability: Improving health literacy(18 months)
- Improving patient sovereignty(9 months and 18 months)
- Assessment of stability: Improving patient sovereignty(18 months)
- Assessment of stability in patients with diabetes: Comparison of blood HbA1c levels after 18 months.(18 months)
- Assessment of stability for patients with current nicotine abuse: determination of/review of smoking cessation after 18 months.(18 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.(9 months)
- For patients with current nicotine abuse: determination of/review of smoking cessation after 9 months.(9 months)