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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial 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.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Perceptions

Perceptions explored through semi-structured interviews

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)
2

Attitudes and expectatives

Attitudes and expectatives explored through semi-structured interviews

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)
3

MASH-related knowledge

MASH-related knowledge explored through semi-structured interviews

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)
4

Unmet needs

Unmet needs explored through semi-structured interviews

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)

Secondary outcomes

Other outcomes

Sponsors and contacts

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