Investigation and Validation of a Study Project on Digital Therapy Management of Patients With Arterial Hypertension

NCT05580068 | Recruiting

• 1 other identifier: 02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pilot study is to exploratively test the basic feasibility of a clinical trial for the controlled investigation of the efficacy and effectiveness of iATROS digital therapy management in the treatment of patients with arterial hypertension within the framework of a clinical trial. In addition, the results of the treatment will be used to generate an initial data basis for the effectiveness of treatment with iATROS.

Conditions

Cardiovascular Diseases; Hypertension

Keywords

eHealth; cardiology; hypertension

Outcome Measures

Primary Outcomes (1)

• Exploratory testing of study-related measures and the use of iATROS.

  Determination of subjective burden perception of the study-related measures using the Study Participant Feedback Questionnaire (SPFQ) - Questionnaire. The three subscales (A-C) are administered at three discrete time points, immediately after enrolment, after half the in-live phase time has passed and at the last visit in the study center. The questions are answered on a 5-point scale with a higher level indicating a higher satisfaction with the study-related measures. Possible levels are 0 to 24 (subscale A), 0 to 39 (subscale B) and 0 to 14 (subscale C).

  Baseline and study completion, an average of 180 days

Secondary Outcomes (5)

• Blood pressure reduction

  Baseline and 90 days after enrolment

• Blood pressure classification

  Baseline, 90 days, and 180 days after enrolment

• Health Literacy Questionnaire (HLQ)

  Baseline and 90 days after enrolment

• Patient Activation Measure (PAM)

  Baseline and 90 days after enrolment

• Blood pressure reduction effect stability

  90 days and 180 days after enrolment

Study Arms (2)

Intervention Group

EXPERIMENTAL

The intervention to be carried out in the treatment group is the use of the therapy measures for the treatment of arterial hypertension, which is delivered through the iATROS medical device. The therapy by means of the medical device takes place over 90 days.

Device: Hypertension therapy through iATROS medical device

Control Group

NO INTERVENTION

For the duration of the in-life phase, the treatment of the control group will follow the standard-of-care except for the measures necessary for the conduct of the study.

Interventions

Hypertension therapy through iATROS medical device DEVICE

The intervention to be carried out in the treatment group is the use of the therapy support provided by the iATROS medical device for the treatment of arterial hypertension. In particular, patients are guided through a structured digital therapy program that enables them to better manage their disease. Patient receive reminders for taking their medication, for performing vital parameter measurements, and receive educational content for them to learn how to manage their disease better.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years of age
• Possession and use of a smartphone that allows the installation and use of "iATROS", whereby "use" implies that the patient possesses the physical and mental abilities to use and apply the iATROS app

You may not qualify if:

• Lack of capacity to consent
• \< 18 years of age
• No use of a smartphone
• Lack of the physical and mental abilities necessary to use the iATROS app, or generally to use so-called "apps" on a smartphone or tablet.
• Tumor disease associated with a reduced life expectancy of less than 1 year
• Immunosuppression
• Advanced dementia
• Any other disease associated with a reduced life expectancy of less than 1 year
• Any disease/condition that limits participation in the program
• Pregnant or breastfeeding patients
• A secondary hypertension known to the patient (by history)
• Existing participation and enrollment in the iATROS hypertension health program.
• Participation in another clinical trial, if complications with compliance, the measures to be performed, a distortion of the results, or the status of a treatment according to the current standard of care result from the participation.
• Comorbidities or the presence of any other physical condition that would prohibit the use of the ESC Hypertension Guideline of 2018 as target blood pressure (i.e. if, due to the patient's individual situation, a different value should be given as a target value for a blood pressure value to be classified as healthy).
• Addictions

Sponsors & Collaborators

• iATROS GmbH: lead

Study Sites (1)

Medizinische Klinik und Poliklinik 1, Ludwig-Maximilians-University of Munich

Munich, Bavaria, 80336, Germany

RECRUITING

Related Publications (1)

• Schlichtiger J, Struven A, Massberg S, von Degenfeld G, Leber A, Weyh P, Meyer J, Brunner S, Stremmel C. Evaluation of a digital therapy programme for the treatment of primary arterial hypertension: eXPLORE - study protocol for a fully decentralised randomised controlled feasibility study. BMJ Open. 2024 Sep 5;14(9):e081347. doi: 10.1136/bmjopen-2023-081347.

  PMID: 39237273 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

• Stefan Brunner, Prof. Dr.

  Medizinische Klinik und Poliklinik 1, Ludwig-Maximilians-University of Munich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Weyh

CONTACT

+49 176 856 23 142; paul.weyh@i-atros.com

Georges von Degenfeld, Dr. med.

CONTACT

+49 89 - 95879243; georges.degenfeld@i-atros.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: monocentric randomized controlled study (RCT)

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 14, 2022
• Study Start: November 10, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)