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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
lipodia
BehavioralParticipants will receive access to the digital health intervention lipodia in addition to TAU.
Treatment groups
272 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Fasting LDL-C levels
Time frame
6 monthsSecondary outcomes
1
Patients' activation
Assessed with the total score of the PAM-13. Higher scores indicate higher patient activation (better outcome).
Time frame
6 months2
Fasting non-HDL-C levels
Time frame
6 months3
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 months4
BMI
Time frame
6 monthsOther outcomes
1
Patients' activation
Assessed with the total score of the PAM-13. Higher scores indicate higher patient activation (better outcome).
Time frame
3 months2
Fasting non-HDL-C levels
Time frame
3 months3
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
3 months4
BMI
Time frame
3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Gaia AG
Lead sponsor
University of Kiel
Collaborator
Source ClinicalTrials.gov