Effects of a Digital Health Application (Lipodia) on LDL-cholesterol Levels (NCT05988866) | Clinical Trial Compass
CompletedNot Applicable
Effects of a Digital Health Application (Lipodia) on LDL-cholesterol Levels
Germany278 participantsStarted 2025-02-03
Plain-language summary
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)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used a digital health app called Lipodia to try to lower LDL cholesterol — since the trial is now completed, has any data been published on whether the app actually helped reduce LDL levels, and would those results be relevant to my situation?
2Since this was a non-drug intervention focused on a digital app rather than a medication, how does that change what we know about its safety compared to, say, a Phase 1 or Phase 2 drug trial?
3My LDL management might also be addressed through established medications or lifestyle programs — given that this trial is already completed and I can't enroll, would you recommend I consider any of the approaches it likely tested, like structured digital coaching, as part of my current care plan?
4Since the trial measured fasting LDL-C as its main outcome, do you think my own fasting LDL levels are the right marker to be tracking, or are there other cholesterol or cardiovascular risk measures I should also be paying attention to?
5Given that I have hypercholesterolemia or a related lipid condition similar to what this trial studied, are there any currently enrolling trials or evidence-based digital health tools similar to Lipodia that you'd think are worth exploring alongside or instead of standard treatment?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.