Actively Recruiting
Clinical Study to Investigate and Validate Digital Therapy Management for Risk Factor Adjustment in Patients with Coronary Heart Disease
Led by iATROS GmbH · Updated on 2024-03-06
1000
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effectiveness of the iATROS digital therapy management system to help adjust risk factors in patients with coronary heart disease (CHD). The study compares this digital approach to the standard medical care currently used. It also aims to test how well the iATROS platform's rule engine works in treating CHD and explores using smartphones for ongoing prevention and therapy management in daily life. Participants are randomly assigned to one of two groups. The intervention group uses the iATROS medical device and app, along with measuring devices to track vital signs at home. This active treatment phase lasts 9 months, followed by an additional 9 months where patients continue using the device to assess the stability of results. The control group receives standard care for 9 months without intervention, then gains access to the iATROS device and measuring tools to observe effects after their delayed use. During the study, participants will have their LDL cholesterol and blood pressure monitored, along with other measures like blood sugar levels for diabetic patients, body mass index for those with obesity, and smoking cessation status for smokers. Health literacy and patient independence are also assessed at 9 and 18 months. The study includes regular assessments of these outcomes and safety checks over a total of 18 months to evaluate the lasting impact of the digital therapy management.
CONDITIONS
Brief Title
Clinical Study for the Investigation and Validation of a Therapy Procedure for the Adjustment of Risk Factors in Patients With Coronary Heart Disease by Means of Digital Therapy Control
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Diagnosed with ischemic heart disease (ICD I20 to I25) with at least one of the following: inpatient stay with acute or historic STEMI/NSTEMI, coronary stent implantation, angioplasty, or bypass surgery
- Own and use a smartphone capable of installing and operating the iATROS app
- Have the physical and mental ability to use the iATROS app
- Insured with cooperating insurance providers
You will not qualify if you...
- Do not use a smartphone
- Lack the necessary linguistic, physical, or mental abilities to use the iATROS app or similar smartphone/tablet apps
- Have a disease with a life expectancy less than 2 years or any condition limiting participation
- Are pregnant or breastfeeding
- Have advanced dementia
- Currently participating or enrolled in an iATROS health program
- Participating in another clinical trial that could affect compliance or results
- Have comorbidities or physical conditions that complicate setting clinical target parameters
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 9 months
Participants in the treatment group use the iATROS medical device and app to manage therapy for coronary heart disease. They receive measuring devices for vital parameters and are guided through app setup and data transfer at home.
Visits correspond to device use and monitoring at home; specific visit schedule not provided
Duration - 9 months
After the active study phase, participants continue to use the iATROS device to assess the stability of treatment effects over an additional 9 months.
Ongoing monitoring with device use at home; no specific visit schedule provided
Trial Site Locations
Total: 1 location
1
Klinikum der Ludwig-Maximilians-Universität München (Klinikum der Universität München), Medizinische Klinik und Poliklinik I
Munich, Bavaria, Germany, 81377
Actively Recruiting
Research Team
P
Paul Weyh, M. Sc.
G
Georges von Degenfeld, Dr. med.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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