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Recruiting NCT07188220

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

— Observational Metabolic Dysfunction Associated Steatohepatitis (MASH)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Metabolic Dysfunction Associated Steatohepatitis (MASH). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Primary outcome measures

  • 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)]
  • 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)]
  • 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)]
  • 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)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Other

Study locations

Spain · 2 centers
  • IR Sant Pau — Barcelona
  • IR Sant Pau — Barcelona

Identifiers

NCT: NCT07188220 · 25/093 (OBS)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗