Using a digital health app to lower bad 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
This study tests if using the Lipodia app can help adults with high cholesterol lower their bad cholesterol levels better than just sticking to their usual treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 272 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Gaia AG Industry-sponsored |
| Locations | 1 site (Hamburg) |
| Trial ID | NCT05988866 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Lipodia, a digital health application, in lowering LDL cholesterol levels in adults diagnosed with hypercholesterolemia. Participants will be divided into two groups: one using the Lipodia app alongside their usual treatment and the other continuing with their usual treatment alone. The study will assess changes in cholesterol levels and other health outcomes over a six-month period through online questionnaires and lab visits for blood tests. The goal is to determine if the digital intervention can enhance cholesterol management and overall health confidence.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of hypercholesterolemia and elevated LDL cholesterol levels.
Not a fit: Patients with genetic conditions like Homozygous Familial Hypercholesterolemia or Hyperlipidemia type III may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide a new tool for patients to better manage their cholesterol levels and improve their health outcomes.
How similar studies have performed: Other studies have shown promise in using digital health interventions for managing cholesterol, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hamburg
- Gaia Ag — Hamburg, Germany (Recruiting)
Study contacts
- Principal investigator: Kamila Jauch-Chara, Prof. — Christian-Albrechts-Universität zu Kiel
- Study coordinator: Björn Meyer, PhD
- Email: bjoern.meyer@gaia-group.com
- Phone: +49.176.1039.2337
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.