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

Hypercholesterolemia Clinical Trial

— DIGICHOL  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05988866
• Other study ID #: lipodia RCT 2024
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2024
• Est. completion date: March 2026

Study information

• Verified date: February 2024
• Source: Gaia AG
• Contact: Björn Meyer, PhD
• Phone: +49.176.1039.2337
• Email: bjoern.meyer[@]gaia-group.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 272
• Est. completion date: March 2026
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias
• Hypercholesterolemia

Intervention

Behavioral:
• lipodia
Participants will receive access to the digital health intervention lipodia in addition to TAU.

Locations

Country	Name	City	State
Germany	GAIA AG	Hamburg

Sponsors (3)

Lead Sponsor	Collaborator
Gaia AG	Deutsche Stiftung für chronisch Kranke, University Hospital, Aachen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patients' activation	PAM-13	3 months
Other	Percent change in fasting non-HDL-C levels from baseline		3 months
Other	Percent change in fasting triglyceride levels from baseline		3 months
Other	Percent change in fasting HDL-C levels from baseline		3 months
Other	Responder analysis for LDL-C levels	% of patients reaching risk-adapted target	3 months
Other	Health-related quality of life	AQoL-8D	3 months
Other	BMI		3 months
Other	Health literacy	HLQ	6 months
Other	Perceived efficacy in patient-physician-interactions	PEPPI-5	6 months
Other	Autonomy preference	API	6 months
Other	Percent change in fasting remnant cholesterol levels (non-HDL-C minus LDL-C)		6 months
Primary	Percent change in fasting LDL-C levels from baseline		6 months
Secondary	Patients' activation	PAM-13	6 months
Secondary	Percent change in fasting non-HDL-C levels from baseline		6 months
Secondary	Percent change in fasting triglyceride levels from baseline		6 months
Secondary	Responder analysis for LDL-C levels	% of patients reaching risk-adapted target	6 months
Secondary	Percent change in fasting HDL-C levels from baseline		6 months
Secondary	Health-related quality of life	AQoL-8D	6 months
Secondary	BMI		6 months
Secondary	Percent change in fasting LDL-C levels from baseline		3 months