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| Name | Class |
|---|---|
| University of Kiel | OTHER |
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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:
Researchers will compare two groups:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | 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. |
|
| Control group | No Intervention | Participants allocated to the control group will receive access to treatment as usual (TAU). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lipodia | Behavioral | Participants will receive access to the digital health intervention lipodia in addition to TAU. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fasting LDL-C levels | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patients' activation | Assessed with the total score of the PAM-13. Higher scores indicate higher patient activation (better outcome). | 6 months |
| Fasting non-HDL-C levels | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patients' activation | Assessed with the total score of the PAM-13. Higher scores indicate higher patient activation (better outcome). | 3 months |
| Fasting non-HDL-C levels | 3 months |
Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Kamila Jauch-Chara, Prof. | Christian-Albrechts-Universität zu Kiel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GAIA AG | Hamburg | 22085 | Germany |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Health-related quality of life | Assessed with the total score of the AQoL-8D. Higher scores indicate higher quality of life (better outcome). | 6 months |
| BMI | 6 months |
| Fasting triglyceride levels | 6 months |
| Fasting HDL-C levels | 6 months |
| Fasting LDL-C levels | 3 months |
| Health-related quality of life | Assessed with the total score of the AQoL-8D. Higher scores indicate higher quality of life (better outcome). | 3 months |
| BMI | 3 months |
| Fasting triglyceride levels | 3 months |
| Fasting HDL-C levels | 3 months |