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

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ClinicalTrials.gov Identifier: NCT05988866
Recruitment Status : Not yet recruiting
First Posted : August 14, 2023
Last Update Posted : February 16, 2024
Sponsor:
Collaborators:
University Hospital, Aachen
Deutsche Stiftung für chronisch Kranke
Information provided by (Responsible Party):
Gaia AG

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Hypercholesterolemia Dyslipidemias Behavioral: lipodia Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 272 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Study visit staff and the laboratory are blinded regarding the patient's study group.
Primary Purpose: Treatment
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
Estimated Study Start Date : October 2024
Estimated Primary Completion Date : October 2025
Estimated Study Completion Date : March 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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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).


Outcome Measures
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Primary Outcome Measures :
  1. Percent change in fasting LDL-C levels from baseline [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Patients' activation [ Time Frame: 6 months ]
    PAM-13

  2. Percent change in fasting non-HDL-C levels from baseline [ Time Frame: 6 months ]
  3. Percent change in fasting triglyceride levels from baseline [ Time Frame: 6 months ]
  4. Responder analysis for LDL-C levels [ Time Frame: 6 months ]
    % of patients reaching risk-adapted target

  5. Percent change in fasting HDL-C levels from baseline [ Time Frame: 6 months ]
  6. Health-related quality of life [ Time Frame: 6 months ]
    AQoL-8D

  7. BMI [ Time Frame: 6 months ]
  8. Percent change in fasting LDL-C levels from baseline [ Time Frame: 3 months ]

Other Outcome Measures:
  1. Patients' activation [ Time Frame: 3 months ]
    PAM-13

  2. Percent change in fasting non-HDL-C levels from baseline [ Time Frame: 3 months ]
  3. Percent change in fasting triglyceride levels from baseline [ Time Frame: 3 months ]
  4. Percent change in fasting HDL-C levels from baseline [ Time Frame: 3 months ]
  5. Responder analysis for LDL-C levels [ Time Frame: 3 months ]
    % of patients reaching risk-adapted target

  6. Health-related quality of life [ Time Frame: 3 months ]
    AQoL-8D

  7. BMI [ Time Frame: 3 months ]
  8. Health literacy [ Time Frame: 6 months ]
    HLQ

  9. Perceived efficacy in patient-physician-interactions [ Time Frame: 6 months ]
    PEPPI-5

  10. Autonomy preference [ Time Frame: 6 months ]
    API

  11. Percent change in fasting remnant cholesterol levels (non-HDL-C minus LDL-C) [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05988866


Contacts
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Contact: Björn Meyer, PhD +49.176.1039.2337 bjoern.meyer@gaia-group.com
Contact: Antje Riepenhausen, M.Sc. antje.riepenhausen@gaia-group.com

Locations
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Germany
GAIA AG
Hamburg, Germany, 22085
Contact: Björn Meyer, PhD       bjoern.meyer@gaia-group.com   
Contact: Antje Riepenhausen, M.Sc.       antje.riepenhausen@gaia-group.com   
Sponsors and Collaborators
Gaia AG
University Hospital, Aachen
Deutsche Stiftung für chronisch Kranke
Investigators
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Principal Investigator: Dirk Müller-Wieland, MD Klinisches Studienzentrum, Medizinische Klinik I, Universitätsklinikum Aachen, Pauwelsstraße 30, 52074 Aachen
More Information
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Responsible Party: Gaia AG
ClinicalTrials.gov Identifier: NCT05988866    
Other Study ID Numbers: lipodia RCT 2024
First Posted: August 14, 2023    Key Record Dates
Last Update Posted: February 16, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gaia AG:
LDL-C
digital intervention
Additional relevant MeSH terms:
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Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases