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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGaia AG

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

272 Participants
are divided into 2 treatment groups

Locations

1
GAIA AG22085, Hamburg Germany

Sponsors and collaborators

Gaia AG

Lead sponsor

University of Kiel

Collaborator