Positive Care Effect of the Digital Health Assistant ADELE Blood Pressure for Hypertension Patients
- Conditions
- Essential (Primary) HypertensionHypertensive Heart Disease With (Congestive) Heart FailureHypertensive Heart Disease Without (Congestive) Heart FailureOther Secondary HypertensionSecondary Hypertension, UnspecifiedSyncope and CollapseDizziness and Giddiness
- Registration Number
- NCT06663280
- Lead Sponsor
- Alma Phil Gmbh
- Brief Summary
High blood pressure (hypertension) can cause damage to vital organs such as the heart, kidneys, eyes, brain and blood vessels. The risk of developing high blood pressure increases with age. High blood pressure is the leading risk factor for death worldwide. The digital health assistant ADELE Blood Pressure A0007 (ADELE for short) improves the daily lives of patients with high blood pressure and enhances patient care. The study aims to varify a positive effect of ADELE on the care of patients with hypertension. The study participants were randomly assigned to one of two groups. Participants in the intervention group were provided with ADELE to use during the study period for voice-based recording, interpretation and classification of their vital signs and body conditions. ADELE provides daily guideline-based knowledge modules on how to better manage the chronic disease. In addition, participants in the intervention group were able to use ADELE to set reminders, for example, to take their medication regularly, exercise regularly and drink enough. The participants in the control group were not provided with ADELE. The objective of the study is to prove a positive effect of the usage of ADELE on patient sovereignty, adherence (adherence to the therapy jointly agreed by patient and practitioner), health status, blood pressure values and health literacy in order to provide the basis for permanent admission to the routine care of the statutory health insurance if the effect is proven.
- Detailed Description
Hypertension can cause damage to vital organs such as the heart, kidneys, eyes, brain and blood vessels. The risk of developing high blood pressure increases with age. Hypertension is the leading risk factor for death worldwide. The digital health assistant ADELE Blood Pressure A0007 (ADELE for short) improves the daily lives of patients with high blood pressure and enhances patient care. The study aims to varify a positive effect of ADELE on the care of patients with hypertension. The functions of ADELE are based on the recommendations of medical guidelines. The study was designed to confirm the positive care effect of the already empirically proven guideline recommendations in everyday use with ADELE.
A prospective randomized multicenter study with a parallel group design was used.
To conduct the study, adult participants with hypertension were randomly assigned to the intervention group or the control group as part of a 1:1 randomization. The observation period per participant was 3 months on average. The data was collected by means of questionnaires. ADELE was provided to the intervention group. ADELE was not provided to the participants in the control group. The primary objective of the study was defined as the improvement in patient sovereignty, measured after 3 months. The improvement in adherence, measured after 3 months, and the improvement in health status, measured after 3 months, were defined as secondary endpoints. The additional exploratory endpoints defined concern, for example, the reduction in systolic and diastolic blood pressure values and the improvement in health literacy.
The objective of the study is to prove a positive effect of the usage of ADELE on patient sovereignty, adherence (adherence to the therapy jointly agreed by patient and practitioner), health status, blood pressure values and health literacy in order to provide the basis for permanent admission to the routine care of the statutory health insurance if the effect is proven.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 108
- Consent to participate in the study
- Medically diagnosed and treated hypertension
- Regular use of at least 1 anti-hypertensive drug with increased overall cardiovascular risk or diabetes mellitus (stroke, heart attack, heart failure, CHD, after bypass / stent surgery, etc.) or 3 anti-hypertensive drugs
- Person must be able to understand the patient information
- Written informed consent form is signed at the beginning of interview 1
- Persons belonging to specially protected groups (e.g. persons temporarily or permanently unable to give consent)
- Person suffers from mental illness that prevents them from understanding the information about the study, giving their consent or complying with the requirements of the study
- Person is unable to operate the application properly
- Person has already had contact with the application and/or a comparable application
- Person is participating in another study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change of patient autonomy From enrollment to the end of treatment at 3 months Change of patient autonomy, measured after 3 months based on Hypertension evaluation of lifestyle and management (HELM) scale. The HELM knowledge scale had 14 items across 3 domains: general hypertension knowledge, lifestyle and medication management, and measurement and treatment goals. The score is between 0 (Minimum) and 14 (Maximum). A higher value is better.
- Secondary Outcome Measures
Name Time Method Change of adherence From enrollment to the end of treatment at 3 months Change of adherence, measured after 3 months based on Hill-Bone Compliance to High Blood Pressure Therapy Scale (HB-HBP). The scale is based on 14 items. Minimum is 56, Maximum is 0. A lower score is better.
Change of health condition From enrollment to the end of treatment at 3 months Change of health condition, measured after 3 months using Short Form 12 Health Survey (SF-12). The scale is based on 12 items. The score is between 0 (Minimum) and 100 (Maximum). A higher value is better.
Trial Locations
- Locations (2)
Ökumenische Sozialstation Heidenheimer Land
🇩🇪Heidenheim, Baden-Wuerttemberg, Germany
Johanniter-Unfall-Hilfe e.V.
🇩🇪Hannover, Niedersachsen, Germany