Metabolic Dysfunction Associated Steatohepatitis (MASH)NCT07188220
Patients' Perspectives on Metabolic Dysfunction-associated Steatohepatitis: a Qualitative Study
An observational study of Metabolic Dysfunction Associated Steatohepatitis (MASH), run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 2 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metabolic Dysfunction Associated Steatohepatitis (MASH)
- How many people
- 25 participants
- Where
- 2 sitesSpain
- Study dates
- 3 Jun 2025to 20 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
IR Sant Pau
Barcelona, 08041
Marina Idalia Rojo López Barcelona, +34 93 556 56 17 ext. 1960, mrojo@santpau.cat
- Recruiting
IR Sant Pau
Barcelona
Marina Idalia Rojo López, 93 556 56 17 ext. 1960, mrojo@santpau.cat
About this study
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
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:
Read more
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.
- Keywords
- Qualitative, MASH, MASLD, Perceptions, Semi-structured interviews
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceptions
Perceptions explored through semi-structured interviews
Measured: 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
Attitudes and expectatives explored through semi-structured interviews
Measured: 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
MASH-related knowledge explored through semi-structured interviews
Measured: 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
Unmet needs explored through semi-structured interviews
Measured: At baseline (within two weeks before starting the programme) and at one-year follow-up (within two weeks before and after completing the programme)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start3 Jun 2025
- Primary completion20 Dec 2027 (estimated)
- Study completion20 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction Associated Steatohepatitis (MASH)Studies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188220
- Sponsor's protocol ID
- 25/093 (OBS)
- Status last verified
- Jul 2025
- First submitted
- 30 Jul 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07188220
- Acronym / sponsor ID
- 25/093 (OBS)
- Keywords
- Qualitative, MASH, MASLD, Perceptions, Semi-structured interviews
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- 20 Dec 2027 (estimated)
- Study completion
- 20 Jan 2028 (estimated)
- First posted
- 23 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Perceptions explored through semi-structured interviews
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)
Attitudes and expectatives explored through semi-structured interviews
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)
MASH-related knowledge explored through semi-structured interviews
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)
Unmet needs explored through semi-structured interviews
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Dysfunction Associated Steatohepatitis (MASH), run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.