Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-03-01 @ 6:10 AM
Study NCT ID:
NCT07188220
Status:
RECRUITING
Last Update Posted:
2025-09-23
First Post:
2025-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patients' Perspectives on Metabolic Dysfunction-associated Steatohepatitis: a Qualitative Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-01-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2025-07-30', 'studyFirstSubmitQcDate': '2025-09-16', 'lastUpdatePostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perceptions', 'timeFrame': 'At baseline (within two weeks before starting the programme) and at one-year follow-up (within two weeks before and after completing the programme)', 'description': 'Perceptions explored through semi-structured interviews'}, {'measure': 'Attitudes and expectatives', 'timeFrame': 'At baseline (within two weeks before starting the programme) and at one-year follow-up (within two weeks before and after completing the programme)', 'description': 'Attitudes and expectatives explored through semi-structured interviews'}, {'measure': 'MASH-related knowledge', 'timeFrame': 'At baseline (within two weeks before starting the programme) and at one-year follow-up (within two weeks before and after completing the programme)', 'description': 'MASH-related knowledge explored through semi-structured interviews'}, {'measure': 'Unmet needs', 'timeFrame': 'At baseline (within two weeks before starting the programme) and at one-year follow-up (within two weeks before and after completing the programme)', 'description': 'Unmet needs explored through semi-structured interviews'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Qualitative', 'MASH', 'MASLD', 'Perceptions', 'Semi-structured interviews'], 'conditions': ['Metabolic Dysfunction Associated Steatohepatitis (MASH)']}, 'descriptionModule': {'briefSummary': 'The aim of this qualitative study is to explore and identify the expectations, perceptions, attitudes, needs, and knowledge related to the management of metabolic dysfunction-associated steatohepatitis (MASH) in patients diagnosed with this condition, before and after their participation in the MASH-Cardiovascular Programme at Hospital de la Santa Creu i Sant Pau, Barcelona.\n\nThe main research question is:\n\nWhat expectations, attitudes, needs, and perceptions do patients with MASH participating in the MASH-Cardiovascular Programme exhibit before and after the intervention?\n\nParticipants will undergo two semi-structured interviews: one prior to, and one following, their involvement in the MASH-Cardiovascular Programme at Hospital de Sant Pau i la Santa Creu, Barcelona.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of individuals diagnosed with MASH who are referred to the multidisciplinary MASH-Cardiovascular Programme at Hospital de la Santa Creu i Sant Pau in Barcelona.', 'genderDescription': 'The semi-structured interview includes a specific gender identity question: Which gender do you identify with?\n\n* Woman\n* Man\n* Non-binary\n* Prefer not to answer', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who voluntarily agree to participate in the MASH-Cardiovascular Programme.\n* Patients followed in the outpatient hepatology/gastroenterology clinic at Hospital de Sant Pau with a diagnosis of MASH and fibrosis stage F2-F4.\n* Patients aged between 18 and 75 years.\n* Patients with a BMI ≥ 27 kg/m².\n* Patients who consent to participate in the study-specific interviews.\n\nExclusion Criteria:\n\n* Patients who do not agree to participate in the study-specific interviews.\n* Patients meeting exclusion criteria of the MASH-Cardiovascular Programme:\n* Patients with decompensated liver cirrhosis.\n* Patients who are vegetarians or have dietary habits/preferences that prevent adherence to standard-of-care nutritional guidelines.\n* Patients with moderate-to-severe alcohol consumption (\\>20 g/day for women and \\>40 g/day for men).\n* Patients with an eGFR \\< 30 mL/min.\n* Patients with malnutrition.\n* Patients with type 1 diabetes or other forms of diabetes.\n* Patients who are candidates for bariatric surgery.\n* Patients with active malignancy.\n* Patients with advanced or unstable heart failure.\n* Patients with eating disorders or severe psychiatric illness.\n* Patients currently enrolled in another clinical trial.\n* Pregnant women or women planning to become pregnant.'}, 'identificationModule': {'nctId': 'NCT07188220', 'briefTitle': "Patients' Perspectives on Metabolic Dysfunction-associated Steatohepatitis: a Qualitative Study", 'organization': {'class': 'OTHER', 'fullName': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}, 'officialTitle': 'Perspectives on the Multidisciplinary Approach to Metabolic Dysfunction-associated Steatohepatitis: a Qualitative Study With Patients From the MASH-Cardiovascular Programme at Hospital de Sant Pau i la Santa Creu, Barcelona', 'orgStudyIdInfo': {'id': '25/093 (OBS)'}}, 'contactsLocationsModule': {'locations': [{'zip': '08041', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Marina Idalia Rojo López Barcelona', 'role': 'CONTACT', 'email': 'mrojo@santpau.cat', 'phone': '+34 93 556 56 17', 'phoneExt': '1960'}], 'facility': 'IR Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Marina Idalia Rojo López', 'role': 'CONTACT', 'email': 'mrojo@santpau.cat', 'phone': '93 556 56 17', 'phoneExt': '1960'}], 'facility': 'IR Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}