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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 272}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-18', 'studyFirstSubmitDate': '2023-08-03', 'studyFirstSubmitQcDate': '2023-08-03', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "Patients' activation", 'timeFrame': '3 months', 'description': 'Assessed with the total score of the PAM-13. Higher scores indicate higher patient activation (better outcome).'}, {'measure': 'Fasting non-HDL-C levels', 'timeFrame': '3 months'}, {'measure': 'Health-related quality of life', 'timeFrame': '3 months', 'description': 'Assessed with the total score of the AQoL-8D. Higher scores indicate higher quality of life (better outcome).'}, {'measure': 'BMI', 'timeFrame': '3 months'}, {'measure': 'Fasting triglyceride levels', 'timeFrame': '3 months'}, {'measure': 'Fasting HDL-C levels', 'timeFrame': '3 months'}], 'primaryOutcomes': [{'measure': 'Fasting LDL-C levels', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': "Patients' activation", 'timeFrame': '6 months', 'description': 'Assessed with the total score of the PAM-13. Higher scores indicate higher patient activation (better outcome).'}, {'measure': 'Fasting non-HDL-C levels', 'timeFrame': '6 months'}, {'measure': 'Health-related quality of life', 'timeFrame': '6 months', 'description': 'Assessed with the total score of the AQoL-8D. Higher scores indicate higher quality of life (better outcome).'}, {'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'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['LDL-C', 'digital intervention'], 'conditions': ['Hypercholesterolemia', 'Dyslipidemias']}, 'descriptionModule': {'briefSummary': '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.\n\nThe main questions it aims to answer are:\n\n* Does lipodia, together with regular treatment, lower LDL cholesterol (bad cholesterol) better than regular treatment alone?\n* Does lipodia help improve other health outcomes, like how confident participants feel in managing their health?\n\nResearchers will compare two groups:\n\n* Intervention group: Participants use the lipodia intervention and continue their usual treatment.\n* Control group: Participants continue with their usual treatment only.\n\nParticipants will:\n\n* Fill out questionnaires online and visit a certified lab at the start of the study, after 3 months, and after 6 months\n* Have blood tests at each lab visit to check their cholesterol and other blood fat levels\n* Continue with their usual treatment (both groups) and use lipodia, a digital health app, for six months (intervention group only)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Age ≥ 18\n* 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\n* LDL-C levels above risk-adapted target\n* TG levels \\< 400 mg/dL\n* Stability of potential drug treatment during the last 4 weeks\n* Stability of potential hormonal treatment during the last 6 months\n* Patient was made aware of lifestyle measures by GP or specialist\n* Consent to participation\n* Sufficient knowledge of the German language\n\nExclusion criteria\n\n* Homozygous Familial Hypercholesterolemia (FH), given that it is a genetic condition which is relatively unresponsive to lifestyle changes\n* Hyperlipidemia type III, given that it is a genetic condition which is relatively unresponsive to lifestyle changes\n* Patients receiving plasmapheresis\n* Lp(a) \\> 50 mg/dL\n* current pregnancy or planned pregnancy during the study period\n* planned major operations\n* liver dysfunction\n* end-stage renal failure\n* other systemic conditions that might interfere with successful study participation\n* Plans to change drug (including hormonal) treatment in the upcoming 6 months\n* Use of another digital intervention for hypercholesterolemia/dyslipidemia in the past'}, 'identificationModule': {'nctId': 'NCT05988866', 'acronym': 'DIGICHOL', 'briefTitle': 'Effects of a Digital Health Application (Lipodia) on LDL-cholesterol Levels', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gaia AG'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'lipodia RCT 2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Participants allocated to the intervention group will receive access to lipodia in addition to treatment as usual (TAU).\n\nlipodia 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.\n\nThe 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.', 'interventionNames': ['Behavioral: lipodia']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Participants allocated to the control group will receive access to treatment as usual (TAU).'}], 'interventions': [{'name': 'lipodia', 'type': 'BEHAVIORAL', 'description': 'Participants will receive access to the digital health intervention lipodia in addition to TAU.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22085', 'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Björn Meyer, PhD', 'role': 'CONTACT', 'email': 'bjoern.meyer@gaia-group.com'}, {'name': 'Linda Betz, PhD', 'role': 'CONTACT', 'email': 'linda.betz@gaia-group.com'}], 'facility': 'GAIA AG', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'centralContacts': [{'name': 'Björn Meyer, PhD', 'role': 'CONTACT', 'email': 'bjoern.meyer@gaia-group.com', 'phone': '+49.176.1039.2337'}, {'name': 'Linda Betz, PhD', 'role': 'CONTACT', 'email': 'linda.betz@gaia-group.com'}], 'overallOfficials': [{'name': 'Kamila Jauch-Chara, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Christian-Albrechts-Universität zu Kiel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gaia AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Kiel', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}