NCT07188220 Patients' Perspectives on Metabolic Dysfunction-associated Steatohepatitis: a Qualitative Study
| NCT ID | NCT07188220 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
| Condition | Metabolic Dysfunction Associated Steatohepatitis (MASH) |
| Study Type | OBSERVATIONAL |
| Enrollment | 25 participants |
| Start Date | 2025-06-03 |
| Primary Completion | 2027-12-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 25 participants in total. It began in 2025-06-03 with a primary completion date of 2027-12-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. The main research question is: What expectations, attitudes, needs, and perceptions do patients with MASH participating in the MASH-Cardiovascular Programme exhibit before and after the intervention? Participants 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.
Eligibility Criteria
Inclusion Criteria: * Patients who voluntarily agree to participate in the MASH-Cardiovascular Programme. * Patients followed in the outpatient hepatology/gastroenterology clinic at Hospital de Sant Pau with a diagnosis of MASH and fibrosis stage F2-F4. * Patients aged between 18 and 75 years. * Patients with a BMI ≥ 27 kg/m². * Patients who consent to participate in the study-specific interviews. Exclusion Criteria: * Patients who do not agree to participate in the study-specific interviews. * Patients meeting exclusion criteria of the MASH-Cardiovascular Programme: * Patients with decompensated liver cirrhosis. * Patients who are vegetarians or have dietary habits/preferences that prevent adherence to standard-of-care nutritional guidelines. * Patients with moderate-to-severe alcohol consumption (\>20 g/day for women and \>40 g/day for men). * Patients with an eGFR \< 30 mL/min. * Patients with malnutrition. * Patients with type 1 diabetes or other forms of diabetes. * Patients who are candidates for bariatric surgery. * Patients with active malignancy. * Patients with advanced or unstable heart failure. * Patients with eating disorders or severe psychiatric illness. * Patients currently enrolled in another clinical trial. * Pregnant women or women planning to become pregnant.
Frequently Asked Questions
Who can join the NCT07188220 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Metabolic Dysfunction Associated Steatohepatitis (MASH). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07188220 currently recruiting?
Yes, NCT07188220 is actively recruiting participants. Visit ClinicalTrials.gov or contact Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau to inquire about joining.
Where is the NCT07188220 trial being conducted?
This trial is being conducted at Barcelona, Spain, Barcelona, Spain.
Who is sponsoring the NCT07188220 clinical trial?
NCT07188220 is sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. The trial plans to enroll 25 participants.