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

NCT ID: NCT07188220

Last Updated: 2025-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-03

Study Completion Date

2028-01-20

Brief Summary

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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

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Conditions

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Metabolic Dysfunction Associated Steatohepatitis (MASH)

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IR Sant Pau

Barcelona, , Spain

Site Status RECRUITING

IR Sant Pau

Barcelona, , Spain

Site Status RECRUITING

Countries

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Spain

Facility Contacts

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Marina Idalia Rojo López Barcelona

Role: primary

+34 93 556 56 17 ext. 1960

Marina Idalia Rojo López

Role: primary

93 556 56 17 ext. 1960

Other Identifiers

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25/093 (OBS)

Identifier Type: -

Identifier Source: org_study_id

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