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ClinicalTrials.gov ID

NCT07188220

Lead Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauOTHER

Overall Status

Recruiting

Study Type

Observational

Enrollment

25Estimated

Last Update Posted

Sep 23, 2025Actual

Start Date

Jun 3, 2025Actual

Primary Completion Date

Dec 20, 2027Estimated

Completion Date

Jan 20, 2028Estimated

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

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.

• Metabolic Dysfunction Associated Steatohepatitis (MASH)

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No data available

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.

Observational Model

Other

Time Perspective

Prospective

Lead Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauOTHER

mrojo@santpau.cat93 556 56 17 ext. 1960