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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
272
Participants will receive access to the digital health intervention lipodia in addition to TAU.
GAIA AG
Hamburg, Germany
RECRUITINGFasting LDL-C levels
Time frame: 6 months
Patients' activation
Assessed with the total score of the PAM-13. Higher scores indicate higher patient activation (better outcome).
Time frame: 6 months
Fasting non-HDL-C levels
Time frame: 6 months
Health-related quality of life
Assessed with the total score of the AQoL-8D. Higher scores indicate higher quality of life (better outcome).
Time frame: 6 months
BMI
Time frame: 6 months
Fasting triglyceride levels
Time frame: 6 months
Fasting HDL-C levels
Time frame: 6 months
Fasting LDL-C levels
Time frame: 3 months
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