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

Launched by GAIA AG · Aug 3, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether a digital health application called Lipodia can help lower "bad" cholesterol (LDL cholesterol) in adults with high cholesterol. The researchers want to know if using Lipodia, along with regular medical treatment, is more effective at reducing cholesterol levels compared to just sticking with the usual treatment. They are also interested in seeing if using the app makes people feel more confident about managing their health.

To participate in this study, you need to be at least 18 years old and have been diagnosed with high cholesterol confirmed by a doctor and lab tests. You'll fill out online questionnaires and visit a certified lab for blood tests at the beginning of the study, after three months, and again after six months. If you join the group using Lipodia, you'll continue your usual treatment and use the app for six months. It's important to know that not everyone can join; for example, if you have certain genetic conditions affecting cholesterol or are pregnant, you won't be eligible. This study is currently looking for participants, and everyone is welcome to apply!

Gender

ALL

Eligibility criteria

• • 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