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

NCT06663280 | Completed

• 1 other identifier: APH01-2
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Change of patient autonomy

  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.

  From enrollment to the end of treatment at 3 months

Secondary Outcomes (2)

• Change of adherence

  From enrollment to the end of treatment at 3 months

• Change of health condition

  From enrollment to the end of treatment at 3 months

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

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).

Device: Digital health assistant ADELE

Control group

NO INTERVENTION

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).

Interventions

Digital health assistant ADELE DEVICE

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alma Phil Gmbh: lead

Study Sites (2)

Ökumenische Sozialstation Heidenheimer Land

Heidenheim, Baden-Wurttemberg, 89520, Germany

Location

Johanniter-Unfall-Hilfe e.V.

Hanover, Lower Saxony, 30624, Germany

Location

MeSH Terms

Conditions

Essential Hypertension; Heart Failure; Syncope; Dizziness; Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sensation Disorders

Study Officials

• Thomas Hoffmann, Prof. Dr. med.

  (Minority) shareholder

  STUDY CHAIR

• Oliver Vonend, Prof. Dr. med.

  No affiliation

  PRINCIPAL INVESTIGATOR

• Hans-Peter Reiffen, Prof. Dr. med.

  No affiliation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: October 19, 2024
• First Posted: October 29, 2024
• Study Start: October 7, 2022
• Primary Completion: December 16, 2023
• Study Completion: December 16, 2023
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)