Dyslipidemias, Hypercholesterolemia
Conditions
Keywords
LDL-C, digital intervention
Brief 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)
Interventions
BEHAVIORALlipodia
Participants will receive access to the digital health intervention lipodia in addition to TAU.
Sponsors
Gaia AG
University of Kiel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting LDL-C levels | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients' activation | 6 months | Assessed with the total score of the PAM-13. Higher scores indicate higher patient activation (better outcome). |
| Fasting non-HDL-C levels | 6 months | — |
| Health-related quality of life | 6 months | Assessed with the total score of the AQoL-8D. Higher scores indicate higher quality of life (better outcome). |
| BMI | 6 months | — |
| Fasting triglyceride levels | 6 months | — |
| Fasting HDL-C levels | 6 months | — |
| Fasting LDL-C levels | 3 months | — |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORKamila Jauch-Chara, Prof.
Christian-Albrechts-Universität zu Kiel
Outcome results
None listed