Effects of a Digital Health Application (Lipodia) on LDL-cholesterol Levels (DIGICHOL)
Hypercholesterolemia, Dyslipidemias
About this trial
This is an interventional treatment trial for Hypercholesterolemia focused on measuring LDL-C, digital intervention
Eligibility Criteria
Inclusion Criteria: Age >= 18 Of legal age (can differ from 18 in case the patient's nationality is not German) 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 triglyceride levels < 400 mg/dL Stability of potential drug treatment during the last 4 weeks Stability of potential hormonal treatment during the last 6 months 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 Planned major operations Liver dysfunction End-stage renal failure Other systemic conditions that might interfere with successful study participation Plans to change drug treatment in the upcoming 6 months
Sites / Locations
- GAIA AG
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Intervention group
Control group
Participants allocated to the intervention group will receive access to lipodia in addition to treatment as usual (TAU). lipodia is a digital health application designed for individuals with hypercholesterinemia, accessible through a web browser. The application focuses on treatment methods derived health behavior change and cognitive behavioral therapy (CBT). Topics addressed by lipodia are activity planning and impulse control, dietary habits, physical activity, stress management, mood management, sleep management, weight management, as well as quitting smoking and drinking. The program operates through interactive "dialogues", which are accompanied by illustrations, audio recordings, motivating text messages, worksheets, and summaries. Users are also encouraged to regularly complete short questionnaires to monitor their complaints. Once registered, the program remains accessible for 365 days.
Participants allocated to the control group will receive access to treatment as usual (TAU).