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
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- iATROS GmbH
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Exploratory testing of study-related measures and the use of iATROS.
Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥ 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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Exploratory testing of study-related measures and the use of iATROS.
Time Frame: 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).
Secondary Outcomes
- 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)