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NCT Number: NCT07188220

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

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.

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Key information

Conditions

Metabolic Dysfunction Associated Steatohepatitis (MASH)

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IR Sant Pau, Barcelona, Spain

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Perceptions

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

    Perceptions explored through semi-structured interviews

  2. Attitudes and expectatives

    Time frame: 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 explored through semi-structured interviews

  3. MASH-related knowledge

    Time frame: 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 explored through semi-structured interviews

  4. Unmet needs

    Time frame: 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 explored through semi-structured interviews

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Sep 23, 2025
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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