E78
Conditions
Interventions
Group 1: Oviva Direkt Lipid (app-based digital lifestyle intervention) + care as usual for 24 weeks
Group 2: care as usual for 24 weeks
Sponsors
Oviva AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age =18 years 2. Confirmed diagnosis of disorders of lipoprotein metabolism and other lipidemias (ICD-10 code E78) 3. Dyslipidaemia with the following LDL-C levels at baseline: ?LDL-C =130 mg/dL (=3.4 mmol/L) for participants classified as Low Risk according to ESC guidelines; OR ?LDL-C =100 mg/dL (=2.6 mmol/L) for participants classified as Moderate, High, or Very High Risk according to ESC guidelines 4. Willing and motivated to use a lifestyle intervention 5. Valid and working email address, telephone number, and internet access and willing to maintain these for the duration of the study 6. Sufficient skill in the German language 7. Signed informed consent 8. Ability to use a smartphone or tablet 9. Smartphone available and compatible with the Oviva Direkt App 10. Willing and able to comply with all scheduled visits, laboratory tests, and other study procedures 11. Physical and mental ability to independently carry out behavioural changes and physical activity
Exclusion criteria
Exclusion criteria: 1. Homozygous familial hypercholesterolemia 2. Triglycerides =500 mg/dL (=5.6 mmol/L) 3. Currently pregnant, breastfeeding or planning to become pregnant during the next 6 months (self-reported) 4. Significant cardiovascular event in the last 6 months prior to screening (e.g., stroke, heart attack, cerebral haemorrhage) 5. Average systolic BP at rest =180 mmHg 6. Unstable angina or decompensated heart failure 7. Liver dysfunction 8. End-stage renal failure 9. Secondary causes requiring urgent specialist care (e.g., uncontrolled hypothyroidism, nephrotic syndrome) at investigator’s discretion 10. Known history of alcohol abuse within the last 12 months. 11. Unintentional weight loss >5% in the past 6 months prior to screening 12. Having started treatment with a GLP-1 agonist or SGLT-2 inhibitor in the 6 months prior to screening, or planned during the study 13. Lipid-lowering supplements, e.g., stanols/sterols taken consistently in the preceding 5 weeks 14. History of bariatric surgery or planned surgery during the study 15. Planned absence during the study that may affect data collection and/or participation 16. Current participation in a digital lifestyle intervention or clinical investigation targeting hypercholesterolemia/dyslipidaemia 17. Participation in another clinical study of an investigational drug or device 18. Living in a household with a person currently participating in a lifestyle intervention 19. Severe cognitive and intellectual impairment 20. Severe, active psychiatric disease (e.g., eating disorder, bipolar disorder, schizophrenia, alcohol or drug abuse) 21. Active oncological treatment 22. Terminal diagnosis with a life expectancy of less than 24 months 23. Dependence on the sponsor or investigator (e.g., employees of the sponsor or a study site and their family members) 24. Any other reason which, in the opinion of the investigator, may put the participant at risk because of participation in the study or bias study results 25. Initiation, discontinuation, or clinically significant dose change within 12 weeks prior to baseline (or planned during the study) of: (a) lipid-lowering therapy (statin, ezetimibe, PCSK9 inhibitors, bempedoic acid, fibrate, omega-3 fatty acids, bile acid sequestrant), and/or (b) other medications known to substantially affect lipid levels (e.g., systemic corticosteroids, retinoids, select anti- retrovirals, calcineurin/mTOR inhibitors, oral oestrogen therapy). Short courses (<14 days) of systemic corticosteroids are permitted but will be recorded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of Oviva Direkt Lipid on LDL-C reduction at Week 24 compared to care as usual | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) To evaluate the effect of Oviva Direkt Lipid on non-HDL-C reduction at week 24 compared to care as usual 2) To evaluate the effect of Oviva Direkt Lipid on patient sovereignty at week 24 compared to care as usual, using the PAM-13 questionnaire. 3) To evaluate the effect of Oviva Direkt Lipid on medication adherence at week 24 compared to care as usual, using the A14 questionnaire. | — |
Countries
Germany
Contacts
Public ContactMihail Georgiev
Oviva AG
Outcome results
None listed