Patients' Perspectives on Metabolic Dysfunction-associated Steatohepatitis: a Qualitative Study

NCT07188220 | Recruiting

• 1 other identifier: 25/093 (OBS)
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 2

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.

Conditions

Metabolic Dysfunction Associated Steatohepatitis (MASH)

Keywords

Qualitative; MASH; MASLD; Perceptions; Semi-structured interviews

Outcome Measures

Primary Outcomes (4)

• Perceptions

  Perceptions explored through semi-structured interviews

  At baseline (within two weeks before starting the programme) and at one-year follow-up (within two weeks before and after completing the programme)

• Attitudes and expectatives

  Attitudes and expectatives explored through semi-structured interviews

  At baseline (within two weeks before starting the programme) and at one-year follow-up (within two weeks before and after completing the programme)

• MASH-related knowledge

  MASH-related knowledge explored through semi-structured interviews

  At baseline (within two weeks before starting the programme) and at one-year follow-up (within two weeks before and after completing the programme)

• Unmet needs

  Unmet needs explored through semi-structured interviews

  At baseline (within two weeks before starting the programme) and at one-year follow-up (within two weeks before and after completing the programme)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: The semi-structured interview includes a specific gender identity question: Which gender do you identify with? * Woman * Man * Non-binary * Prefer not to answer
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• Patients who do not agree to participate in the study-specific interviews.
• 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.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead

Study Sites (2)

IR Sant Pau

Barcelona, 08041, Spain

RECRUITING

IR Sant Pau

Barcelona, Spain

RECRUITING

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: September 23, 2025
• Study Start: June 3, 2025
• Primary Completion (Estimated): December 20, 2027
• Study Completion (Estimated): January 20, 2028
• Last Updated: September 23, 2025

Record last verified: 2025-07

Locations

ES (2)