Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-28 @ 5:24 PM
Study NCT ID:
NCT06027034
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-22
First Post:
2023-08-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of a Digital Health Application for Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 348}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-18', 'studyFirstSubmitDate': '2023-08-31', 'studyFirstSubmitQcDate': '2023-09-06', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient Activation', 'timeFrame': '3 months, 6 months, 12 months', 'description': 'Total score of the Patient Activation Measure-13 (PAM-13). Total score ranging from 0-100; higher scores mean a better outcome.'}, {'measure': 'Self-Esteem', 'timeFrame': '3 months, 6 months, 12 months', 'description': 'Total score of the Rosenberg Self-Esteem Scale (RSE). Total score ranging from 0-30; higher scores mean a better outcome.'}, {'measure': 'Body Mass Index', 'timeFrame': '3 months, 6 months, 12 months', 'description': 'Body mass index (BMI) is a simple measure of body fat based on height and weight. Higher values mean a worse outcome.'}, {'measure': 'Alcohol Consumption', 'timeFrame': '3 months, 6 months, 12 months', 'description': 'Total score of the Alcohol use Disorders Identification Test - Consumption Items (AUDIT-C). Total score ranging from 0-12; higher scores mean a worse outcome.'}, {'measure': 'Cigarette Smoking', 'timeFrame': '3 months, 6 months, 12 months', 'description': "Cigarette smoking will be assessed with a single question 'How often do you smoke cigarettes?', with response options 'Never/rarely/sometimes/often/very often', coded from 0-4. Higher scores mean a worse outcome."}], 'primaryOutcomes': [{'measure': 'Health-Related Quality of Life', 'timeFrame': '3 months', 'description': 'Total score of the Dermatology Life Quality Index (DLQI). Total score ranging from 0-30; higher scores mean a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Psoriasis Severity', 'timeFrame': '3 months, 6 months, 12 months', 'description': 'Total score of the Self-Administered Psoriasis Area Severity Index (PASI). Total score ranging from 0-72; higher scores mean a worse outcome.'}, {'measure': 'Depressive Symptoms', 'timeFrame': '3 months, 6 months, 12 months', 'description': 'Total score of the Patient Health Questionnaire (PHQ-9). Total score ranging from 0-27; higher scores mean a worse outcome.'}, {'measure': 'Body Surface Area (BSA)', 'timeFrame': '3 months, 6 months, 12 months', 'description': 'Body Surface Area (BSA) is a measure used to determine the extent of skin involvement in psoriasis. Total score ranging from 0-100; higher scores mean a worse outcome.'}, {'measure': 'Health-Related Quality of Life', 'timeFrame': '6 months, 12 months', 'description': 'Total score of the Dermatology Life Quality Index (DLQI). Total score ranging from 0-30; higher scores mean a worse outcome.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': 'This clinical trial with 348 patients with psoriasis aims to investigate the effectiveness of a self-guided online program for patients with psoriasis.\n\nPatients will be randomized and allocated in a 1:1 ratio to either an intervention group, in which they will receive 12-month-access to an online program for psoriasis in addition to treatment as usual (TAU, n = 174), or to a control group, in which they will receive only TAU (n = 174). TAU is defined as any therapy prescribed or recommended by the GP or specialists (e.g. dermatologist, psychiatrist), which may include topical therapy, phototherapy, pharmacotherapy, psychosocial therapy, etc.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Presence of psoriasis vulgaris or psoriatic arthritis\n* Submission of a specialist medical certificate attesting to the presence of at least one of the following ICD-10-GM diagnoses: Psoriasis vulgaris (L 40.0, L 40.7), Psoriatic arthritis (L40.5, M07.x)\n* Impaired health-related quality of life (DLQI \\> 10)\n* Consent to participate\n* Sufficient understanding of the German language\n\nExclusion Criteria:\n\n* Presence of another subtype of psoriasis (pustular psoriasis, guttate psoriasis, inverse psoriasis, erythrodermic psoriasis, or drug-induced psoriasis) or psoriatic arthritis without skin involvement\n* Presence of malignancies\n* Presence of other chronic diseases with strong negative influence on quality of life\n* Currently undergoing psychiatric treatment / current presence of a severe psychiatric diagnosis\n* Insufficient language and/or IT skills'}, 'identificationModule': {'nctId': 'NCT06027034', 'briefTitle': 'Effectiveness of a Digital Health Application for Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gaia AG'}, 'officialTitle': 'Effectiveness of a Digital Health Application for Psoriasis: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Psoriasis RCT 2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Online program for psoriasis (GAIA-PSO-01) + TAU', 'description': 'Participants allocated to the intervention group will receive access to an online program for psoriasis (GAIA-PSO-01) in addition to treatment as usual (TAU).', 'interventionNames': ['Behavioral: Online program for psoriasis (GAIA-PSO-01)']}, {'type': 'NO_INTERVENTION', 'label': 'TAU', 'description': 'Participants allocated to the control group will receive access to treatment as usual (TAU).'}], 'interventions': [{'name': 'Online program for psoriasis (GAIA-PSO-01)', 'type': 'BEHAVIORAL', 'description': 'The program to-be-tested (GAIA-PSO-01) is an interactive online program for independent use by users with psoriasis. It focuses on recognized treatment elements of cognitive behavioral therapy (CBT) and behavior change techniques.', 'armGroupLabels': ['Online program for psoriasis (GAIA-PSO-01) + TAU']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22085', 'city': 'Hamburg', 'state': 'Hamburg', 'country': 'Germany', 'facility': 'GAIA AG', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'overallOfficials': [{'name': 'Uwe Gieler, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Giessen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gaia AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Giessen', 'class': 'OTHER'}, {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}