Patients' Perspectives on Metabolic Dysfunction-associated Steatohepatitis: a Qualitative Study (NCT07188220) | Clinical Trial Compass
RecruitingNot Applicable
Patients' Perspectives on Metabolic Dysfunction-associated Steatohepatitis: a Qualitative Study
Spain25 participantsStarted 2025-06-03
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Perceptions
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: At baseline (within two weeks before starting the programme) and at one-year follow-up (within two weeks before and after completing the programme)
Trial details
NCT IDNCT07188220
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau