Effects of a Digital Health Application (Lipodia) on LDL-cholesterol Levels

Study Overview
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Brief Summary
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This pragmatic randomized controlled trial (RCT) with 272 patients with hypercholesterolemia aims to investigate the effectiveness of lipodia, an unguided digital health intervention for patients with hypercholesterolemia on plasma lipid levels and other clinical variables. Inclusion criteria are: age ≥ 18 years, presence of hypercholesterolemia, low-density lipoprotein cholesterol (LDL-C) levels above the risk-adapted target, stability of potential drug treatments for at least four weeks, and stability of potential hormonal treatment for at least 6 months, next to provision of informed consent and sufficient knowledge of the German language. Exclusion criteria are plans to change potential drug treatment in the upcoming 6 months, the presence of homozygous familial hypercholesterolemia (FH) or type III hyperlipidemia, receiving plasmapheresis, Lp(a) > 50 mg/dL, triglyceride (TG) above 400 mg/dL, current pregnancy, planned major operations, liver dysfunction, end-stage renal failure, and other systemic diseases that might interfere with successful study participation. Patients will be randomized and allocated to either an intervention group, in which they will receive access to lipodia in addition to treatment as usual (TAU), or to a control group, in which they will receive only TAU. The primary endpoint will be a change in plasma LDL-C levels, with six months post-allocation (T2) being the primary timepoint for assessment of effectiveness. Three months post-allocation (T1) will serve as early-response assessment of endpoints. Secondary endpoints will be patient activation, the change in levels of other plasma lipids (non-high-density lipoprotein cholesterol (non-HDL-C), high-density lipoprotein cholesterol (HDL), TG), responder rate of LDL-C, self-reported health-related quality of life, and BMI.

Official Title
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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

Conditions
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Hypercholesterolemia, Dyslipidemias

Intervention / Treatment
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* Behavioral: lipodia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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. | Behavioral: lipodia<br>* Participants will receive access to the digital health intervention lipodia in addition to TAU.<br>|
| No Intervention: Control group<br>Participants allocated to the control group will receive access to treatment as usual (TAU). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in fasting LDL-C levels from baseline |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' activation | PAM-13 | 6 months | 
| Percent change in fasting non-HDL-C levels from baseline |  | 6 months | 
| Percent change in fasting triglyceride levels from baseline |  | 6 months | 
| Responder analysis for LDL-C levels | % of patients reaching risk-adapted target | 6 months | 
| Percent change in fasting HDL-C levels from baseline |  | 6 months | 
| Health-related quality of life | AQoL-8D | 6 months | 
| BMI |  | 6 months | 
| Percent change in fasting LDL-C levels from baseline |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LDL-C, digital intervention