Positive Care Effect of the Digital Health Assistant ADELE Blood Pressure for Hypertension Patients

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.

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

Interventions

DEVICE

Digital health assistant ADELE

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. 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.

Sponsors & Collaborators

• Alma Phil Gmbh

  lead INDUSTRY

Principal Investigators

• Thomas Hoffmann, Prof. Dr. med. · (Minority) shareholder

• Oliver Vonend, Prof. Dr. med. · No affiliation

• Hans-Peter Reiffen, Prof. Dr. med. · No affiliation

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-07

Primary Completion

2023-12-16

Completion

2023-12-16

Countries

• Germany

Study Locations