Pilot-Studie Zur Explorativen Untersuchung Und Validierung Eines Studienvorhabens Zur Digitalen Therapiesteuerung Von Patienten Mit Arterieller Hypertonie im Vergleich Der Behandlung Mit Dem Standard-of-Care - iATROS eXPLORE
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- iATROS GmbH
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Exploratory testing of study-related measures and the use of iATROS.
研究概览
简要总结
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.
详细描述
The aim of this pilot project is to form the basis for testing the iATROS platform in an controlled setting of a clinical study, in particular to collect data for a more precise determination of the sample size including the investigation of dropout rates, to investigate the acceptance of study-related measures, and to test and better prepare the procedures for the successful implementation of study-related measures. Furthermore, the first data for testing the effectiveness of the iATROS solution for the treatment of hypertensive patients will be collected. For this purpose, health data as well as data points on health literacy and patient sovereignty will be collected from the patients in the pilot study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 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
排除标准
- •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 systolic (mean value of the 7 days). In case of a 24h blood pressure measurement, this value is decisive compared to the at-home measurement.
- •Existing participation and enrollment in the iATROS hypertension health program.
- •Participation in another clinical trial, if complications with compliance, the measures to be performed, a distortion of the results, or the status of a treatment according to the current standard of care result from the participation.
- •Comorbidities or the presence of any other physical condition that would prohibit the use of the ESC Hypertension Guideline of 2018 as target blood pressure (i.e. if, due to the patient's individual situation, a different value should be given as a target value for a blood pressure value to be classified as healthy).
- •Addictions
- •Stroke in the last 3 months
- •Transient ischemic attack (TIA) in the last 3 months
研究组 & 干预措施
Intervention Group
The intervention to be carried out in the treatment group is the use of the therapy measures for the treatment of arterial hypertension, which is delivered through the iATROS medical device. The therapy by means of the medical device takes place over 90 days.
干预措施: Hypertension therapy through iATROS medical device (Device)
Control Group
For the duration of the in-life phase, the treatment of the control group will follow the standard-of-care except for the measures necessary for the conduct of the study.
结局指标
主要结局
Exploratory testing of study-related measures and the use of iATROS.
时间窗: Baseline and study completion, an average of 180 days
Determination of subjective burden perception of the study-related measures using the Study Participant Feedback Questionnaire (SPFQ) - Questionnaire. The three subscales (A-C) are administered at three discrete time points, immediately after enrolment, after half the in-live phase time has passed and at the last visit in the study center. The questions are answered on a 5-point scale with a higher level indicating a higher satisfaction with the study-related measures. Possible levels are 0 to 24 (subscale A), 0 to 39 (subscale B) and 0 to 14 (subscale C).
次要结局
- Blood pressure reduction(Baseline and 90 days after enrolment)
- Blood pressure classification(Baseline, 90 days, and 180 days after enrolment)
- Blood pressure reduction effect stability(90 days and 180 days after enrolment)
- Health Literacy Questionnaire (HLQ)(Baseline and 90 days after enrolment)
- Patient Activation Measure (PAM)(Baseline and 90 days after enrolment)