Patients' perspectives and needs in metabolic dysfunction‑associated steatohepatitis
Official title: 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
Run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · NCT07188220 · Data updated 2026-11-12
This study will see what adults with MASH expect, need, and feel about their care before and after taking part in a cardiovascular health program in Barcelona.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 25 (estimated) |
| Sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Academic / other |
| Locations | 2 sites (Barcelona and 1 other locations) |
| Status | Recruiting |
| Started | June 3, 2025 |
| Main results expected | December 20, 2027 |
| Study ends | January 20, 2028 |
| Registry record updated | September 23, 2025 |
| Trial ID | NCT07188220 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults 18–75 with MASH and fibrosis stage F2–F4 (BMI ≥27 kg/m²) who are enrolled in and willing to be interviewed before and after the MASH-Cardiovascular Programme at Hospital de Sant Pau.
✕Probably not a fit
Patients unlikely to benefit include those not enrolled in the program or those with exclusion conditions such as decompensated cirrhosis, eGFR <30 mL/min, type 1 diabetes, heavy alcohol use, malnutrition, or dietary restrictions that prevent program participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational qualitative study conducts two semi-structured interviews with patients diagnosed with metabolic dysfunction‑associated steatohepatitis (MASH): one before and one after their participation in the MASH-Cardiovascular Programme at Hospital de la Santa Creu i Sant Pau in Barcelona. Participants are adults aged 18–75 with fibrosis stage F2–F4 and BMI ≥27 kg/m² who are followed in the hospital’s hepatology/gastroenterology clinic and who consent to the interviews. Interview topics include expectations, attitudes, knowledge, needs, and perceived barriers to MASH management and lifestyle change. Study team members will analyze transcripts to identify common themes that could inform patient-centered care and program improvements.
Why it matters
Potential benefit: If successful, the findings could help tailor the MASH-Cardiovascular Programme and other care pathways to better meet patients’ needs and improve engagement.
How similar studies have gone: Previous qualitative studies of NAFLD/MASH patient experiences have provided useful insights for care design, but pre‑and‑post interviews tied to a specific cardiovascular program are less commonly reported.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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IR Sant Pau
Barcelona, Spain Recruiting -
IR Sant Pau
Barcelona, Spain Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.