Clinical trial NCT05988866: Effects of a Digital Health Application (Lipodia) on LDL-cholesterol Levels
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypercholesterolemia
Dyslipidemias
Keywords: LDL-C
digital intervention
Lead sponsor: Gaia AG
Sponsor class: INDUSTRY
Collaborators: name: University of Kiel
First posted: 2023-08-14
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility criteria: 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

Primary outcomes:
measure: Fasting LDL-C levels
timeFrame: 6 months
Secondary outcomes:
measure: Patients' activation
timeFrame: 6 months
measure: Fasting non-HDL-C levels
timeFrame: 6 months
measure: Health-related quality of life
timeFrame: 6 months
measure: BMI
timeFrame: 6 months
measure: Fasting triglyceride levels
timeFrame: 6 months
measure: Fasting HDL-C levels
timeFrame: 6 months
measure: Fasting LDL-C levels
timeFrame: 3 months
Other outcomes:
measure: Patients' activation
timeFrame: 3 months
measure: Fasting non-HDL-C levels
timeFrame: 3 months
measure: Health-related quality of life
timeFrame: 3 months
measure: BMI
timeFrame: 3 months
measure: Fasting triglyceride levels
timeFrame: 3 months
measure: Fasting HDL-C levels
timeFrame: 3 months
Locations:
city: Hamburg
country: Germany
facility: GAIA AG
Study officials:
affiliation: Christian-Albrechts-Universität zu Kiel
name: Kamila Jauch-Chara, Prof.
role: PRINCIPAL_INVESTIGATOR
References: