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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
The intervention to be carried out in the treatment group is the use of the therapy support provided by the iATROS medical device for the treatment of arterial hypertension. In particular, patients are guided through a structured digital therapy program that enables them to better manage their disease. Patient receive reminders for taking their medication, for performing vital parameter measurements, and receive educational content for them to learn how to manage their disease better.
Medizinische Klinik und Poliklinik 1, Ludwig-Maximilians-University of Munich
Munich, Bavaria, Germany
RECRUITINGExploratory testing of study-related measures and the use of iATROS.
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).
Time frame: Baseline and study completion, an average of 180 days
Blood pressure reduction
Measurement of blood pressure in mmHg after 90 days of treatment as compared to baseline. Comparison of the mean absolute reduction in systolic blood pressure in intragroup analysis per study arm and between treatment arms (intervention vs. control).
Time frame: Baseline and 90 days after enrolment
Blood pressure classification
Assessment of the fraction of patients in \[%\] with a blood pressure classified as "healthy" as per the definition outlined in the "2018 ESC/ESH Clinical Practice Guidelines for the Management of Arterial Hypertension " after 90 days of treatment and at follow-up at 180 days as compared to baseline. Comparison of the mean absolute reduction in systolic blood pressure in intragroup analysis per study arm and between treatment arms (intervention vs. control).
Time frame: Baseline, 90 days, and 180 days after enrolment
Health Literacy Questionnaire (HLQ)
Administration of the Health Literacy Questionnaire (HLQ) to assess disease-related health literacy. The questionnaire is comprised of 9 subscales. Scale 1-5 are graded on a 4-point scale (possible levels per subscale 1 to 4), scale 6-9 are graded on a 5-point scale (possible levels per subscale 1 to 5) with higher levels showing higher health literacy. Measurement at baseline and at the end of a 90-day treatment period. Assessment of changes in health literacy in intra-group comparison per study arm and inter-group comparison.
Time frame: Baseline and 90 days after enrolment
Patient Activation Measure (PAM)
Measurement of degree of patient activation via the Patient Activation Measure (PAM) questionnaire. Measurement at baseline and at the end of a 90-day treatment period. Assessment of changes in health literacy in intra-group comparison per study arm and inter-group comparison. Possible levels 0 to 100, with a higher level indicating higher activation.
Time frame: Baseline and 90 days after enrolment
Blood pressure reduction effect stability
Measurement of blood pressure level in mmHg 90 days after finishing in-live phase and comparison to blood pressure level 90 days after enrolment. Comparison of the mean absolute reduction in systolic blood pressure in intragroup analysis per study arm and between treatment arms (intervention vs. control).
Time frame: 90 days and 180 days after enrolment
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