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

Recruiting

• Conditions: Metabolic Dysfunction Associated Steatohepatitis (MASH)

• Registration Number: NCT07188220
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-06-03
• Status Verified: 2025-07
• Study First Submitted: 2025-07-30
• Study First Submitted QC: 2025-09-16
• Last Update Submitted: 2025-09-16
• Study First Posted: 2025-09-23
• Last Update Posted: 2025-09-23
• Primary Completion: 2027-12-20
• Study Completion: 2028-01-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Perceptions	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
Attitudes and expectatives	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
MASH-related knowledge	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
Unmet needs	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

Trial Locations

Locations (1)

IR Sant Pau; 🇪🇸 Barcelona, Spain