Effects of a Digital Health Application (Lipodia) on LDL-cholesterol Levels

Effects of a Digital Health Application (Lipodia) on LDL-cholesterol Levels in Individuals With LDL-cholesterol Levels Above Recommended Targets for Reducing Cardiovascular Risk: Randomized Controlled 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)

Inclusion criteria

• 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
• Stability of potential drug treatment during the last 4 weeks
• Stability of potential hormonal treatment during the last 6 months
• Patient was made aware of lifestyle measures by GP or specialist
• Consent to participation
• Sufficient knowledge of the German language

Exclusion criteria

• 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
• current pregnancy or planned pregnancy during the study period
• planned major operations
• liver dysfunction
• end-stage renal failure
• other systemic conditions that might interfere with successful study participation
• Plans to change drug (including hormonal) treatment in the upcoming 6 months
• Use of another digital intervention for hypercholesterolemia/dyslipidemia in the past