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

February 15, 2024 updated by: Gaia AG

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

272

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group

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.
Behavioral: lipodia
Participants will receive access to the digital health intervention lipodia in addition to TAU.
No Intervention: Control group
Participants allocated to the control group will receive access to treatment as usual (TAU).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change in fasting LDL-C levels from baseline
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI
Time Frame: 6 months
6 months
Patients' activation
Time Frame: 6 months
PAM-13
6 months
Percent change in fasting non-HDL-C levels from baseline
Time Frame: 6 months
6 months
Percent change in fasting triglyceride levels from baseline
Time Frame: 6 months
6 months
Responder analysis for LDL-C levels
Time Frame: 6 months
% of patients reaching risk-adapted target
6 months
Percent change in fasting HDL-C levels from baseline
Time Frame: 6 months
6 months
Health-related quality of life
Time Frame: 6 months
AQoL-8D
6 months
Percent change in fasting LDL-C levels from baseline
Time Frame: 3 months
3 months

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gaia AG

Collaborators

University Hospital, Aachen
Deutsche Stiftung für chronisch Kranke

Investigators

  • Principal Investigator: Dirk Müller-Wieland, MD, Klinisches Studienzentrum, Medizinische Klinik I, Universitätsklinikum Aachen, Pauwelsstraße 30, 52074 Aachen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

August 3, 2023

First Submitted That Met QC Criteria

August 3, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • lipodia RCT 2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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