About this trial
The goal of this clinical trial is to find out if lipodia, a digital health intervention, can help lower cholesterol levels and improve other health measures in adults with high cholesterol.
The main questions it aims to answer are:
* Does lipodia, together with regular treatment, lower LDL cholesterol (bad cholesterol) better than regular treatment alone? * Does lipodia help improve other health outcomes, like how confident participants feel in managing their health?
Researchers will compare two groups:
* Intervention group: Participants use the lipodia intervention and continue their usual treatment. * Control group: Participants continue with their usual treatment only.
Participants will:
* Fill out questionnaires online and visit a certified lab at the start of the study, after 3 months, and after 6 months * Have blood tests at each lab visit to check their cholesterol and other blood fat levels * Continue with their usual treatment (both groups) and use lipodia, a digital health app, for six months (intervention group only)
Eligibility criteria
Qualifiers
Age ≥ 18
Diagnosis of hypercholesterolemia (ICD-10 E78.0, E78.2, E78.4, E78.5, E78.8, E78.9) confirmed by a laboratory test and physician diagnosis
LDL-C levels above risk-adapted target
TG levels < 400 mg/dL
Disqualifiers
Homozygous Familial Hypercholesterolemia (FH), given that it is a genetic condition which is relatively unresponsive to lifestyle changes
Hyperlipidemia type III, given that it is a genetic condition which is relatively unresponsive to lifestyle changes
Patients receiving plasmapheresis
Lp(a) > 50 mg/dL
Trial design
Treatments tested in this trial
- lipodia
Treatment groups
Locations
1Sponsors and collaborators
Gaia AG
Lead sponsor
University of Kiel
Collaborator