Patients' perspectives and needs in metabolic dysfunction‑associated steatohepatitis
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
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · NCT07188220
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 |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (other) |
| Locations | 2 sites (Barcelona and 1 other locations) |
| Trial ID | NCT07188220 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Barcelona and 1 other locations
- IR Sant Pau — Barcelona, Spain (RECRUITING)
- IR Sant Pau — Barcelona, Spain (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Metabolic Dysfunction Associated Steatohepatitis, Qualitative, MASH, MASLD, Perceptions, Semi-structured interviews