NCT06663280Completed
Positive Care Effect of the Digital Health Assistant ADELE Blood Pressure for Hypertension Patients
Prospective Randomized Study to Prove a Positive Care Effect of the Digital Health Assistant ADELE Blood Pressure A0007 for Hypertension Patients
Source: ClinicalTrials.gov · Last updated 30 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 108 (actual)
- First submitted
- 19 Oct 2024
- Start date
- 7 Oct 2022
- Primary completion date
- 16 Dec 2023
- Lead sponsor
- Alma Phil Gmbh
- Diseases
- Heart failure, High blood pressure
- NCT number
- NCT06663280
What you commit to
- Study type: Interventional
- Participants enrolled: 108
- From 7 Oct 2022 to the primary completion date, 16 Dec 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Persons belonging to specially protected groups (e.g. persons temporarily or permanently unable to give consent)
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johanniter-Unfall-Hilfe e.V. Coordinator of this site? Confirm its status | Hanover | Germany | Unknown status |
| Ökumenische Sozialstation Heidenheimer Land Coordinator of this site? Confirm its status | Heidenheim | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.