NCT06663280

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Alma Phil Gmbh · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Type	Name	Description
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.

Timeline

• Start date: 2022-10-07
• Primary completion: 2023-12-16
• Completion: 2023-12-16
• First posted: 2024-10-29
• Last updated: 2024-10-30

Locations

2 sites across 1 country: Germany