Clinical trial NCT06663280: Positive Care Effect of the Digital Health Assistant ADELE Blood Pressure for Hypertension Patients
Official title: Prospective Randomized Study to Prove a Positive Care Effect of the Digital Health Assistant ADELE Blood Pressure A0007 for Hypertension Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Essential (Primary) Hypertension
Hypertensive Heart Disease With (Congestive) Heart Failure
Hypertensive Heart Disease Without (Congestive) Heart Failure
Other Secondary Hypertension
Secondary Hypertension, Unspecified
Syncope and Collapse
Dizziness and Giddiness
Keywords: hypertension
digital health
health assistant
Lead sponsor: Alma Phil Gmbh
Sponsor class: INDUSTRY
First posted: 2024-10-29
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group: Participants in the intervention group were patients with hypertension who had been provided ADELE for the duration of the study. The observation period per participant was 3 months on average. Data on the primary, secondary and exploratory endpoints were gathered using questionnaires at study inclusion (t0) and an average of 3 months after randomization (t1). Control group: Participants in the control group were patients with hypertension who were not provided with ADELE for the duration of the study. The observation period per participant was 3 months on average. Data on the primary, secondary and exploratory endpoints were collected using questionnaires at study inclusion (t0) and an average of 3 months after randomization (t1).

In addition, after the end of the observation period (from t0 to t1), the participants in the control group were offered an extension of a further 3 months on average using ADELE (from t1 to t2).
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change of patient autonomy
timeFrame: From enrollment to the end of treatment at 3 months
Secondary outcomes:
measure: Change of adherence
timeFrame: From enrollment to the end of treatment at 3 months
measure: Change of health condition
timeFrame: From enrollment to the end of treatment at 3 months
Other outcomes:
Locations:
city: Heidenheim
country: Germany
facility: Ökumenische Sozialstation Heidenheimer Land
state: Baden-Wuerttemberg
city: Hannover
country: Germany
facility: Johanniter-Unfall-Hilfe e.V.
state: Niedersachsen
Study officials:
affiliation: (Minority) shareholder
name: Thomas Hoffmann, Prof. Dr. med.
role: STUDY_CHAIR
affiliation: No affiliation
name: Oliver Vonend, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: No affiliation
name: Hans-Peter Reiffen, Prof. Dr. med.
role: STUDY_DIRECTOR
References: