Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2025-12-25 @ 5:49 PM
Study NCT ID:
NCT05988866
Status:
RECRUITING
Last Update Posted:
2025-08-22
First Post:
2023-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a Digital Health Application (Lipodia) on LDL-cholesterol Levels
Sponsor:
Gaia AG
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIGICHOL
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)
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)
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: