Non-alcoholic Steatohepatitis (MASH)BARRIERS-MASLDNCT05765890
Barriers to MASLD Management in Europe: Findings From a Multidisciplinary HCP-survey
An observational study of Non-alcoholic Steatohepatitis (MASH) and Non-alcoholic Fatty Liver Disease (MASLD), run by Novo Nordisk A/S at 1 site in India.
Trial summary
The purpose of this study is to better understand the main barriers to earlier diagnosis and better management of MASLD/MASH patients and to understand the key barriers to adoption of guidelines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-alcoholic Steatohepatitis (MASH), Non-alcoholic Fatty Liver Disease (MASLD)
- What is being tested?
- No treatment given
- How many people
- 675 participants
- Where
- 1 siteIndia
- Study dates
- 24 Mar 2023to 12 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Adult, Older adult
Study population: Hepatologists and other metabolically focused healthcare providers (HCPs)
Who may be able to join
- For Hepatologists:
- Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
- Male or female, age above or equal to 18 years at the time of signing informed consent.
- Is a physician
- Lives in UK, France, Germany, Italy or Spain
- Primary medical specialty is:
Show all 14Show fewer
- 5.a. Hepatology or 5.b. Gastroenterology or Internal Medicine with a subspecialty in Hepatology 6. In practice at least 3 years 7. Spends at least 50 percent of their time in an office/clinic setting 8. Spends at least 60 percent of their time in direct patient care 9. Sees at least 15 patients/month with MASH/MASLD
- For Metabolically-Focused HCPs (Endocrinologist/General Physician/Family Physician/Internal Medicine):
- Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
- Male or female, age above or equal to 18 years at the time of signing informed consent.
- Is a physician
- Lives in UK, France, Germany, Italy or Spain
- Primary medical specialty is:
- 5.a. General Physician/Family Practitioner or Endocrinology or 5.b. Internal Medicine without subspecialty in Hepatology 6. In practice at least 3 years 7. Spends less than 50 percent of their time in an office/clinic setting 8. Spends less than 60 percent of their time in direct patient care 9. Sees at least 15 patients/month with suspected/diagnosed MASH/MASLD 10. Sees and actively treats at least 30 patients/month with Type 2 Diabetes (T2D) and/or Obesity
Who cannot join
- Previous participation in this study. Participation is defined as having given informed consent in this study
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Does not meet inclusion criteria requirements
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to better understand the main barriers to earlier diagnosis and better management of MASLD/MASH patients and to understand the key barriers to adoption of guidelines.
This study is a cross-sectional design, conducted across 5 countries in Europe- France, Germany, Spain, United Kingdom (UK), Italy. Study participants, Hepatologists and other metabolically focused healthcare providers (HCPs), will be recruited to complete a 15 minute self-administered online survey.
- Being tested
- No treatment given
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatment givenOther
No treatment given
| Study group | Role | What they receive |
|---|---|---|
| Hepatologists | Recruited via email through online panel companies with which respondents have provided permission to be contacted for research purposes Receives: Other: No treatment given | |
| Metabolically-Focused HCPs | Recruited via email through online panel companies with which respondents have provided permission to be contacted for research purposes Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unaided awareness
Open ended response
Measured: At the time of survey response (Day 1)
Aided awareness
Multi- select from defined list
Measured: At the time of survey response (Day 1)
Behaviours relative to diagnosing and managing MASLD
Numerical, multi-select from defined list
Measured: At the time of survey response (Day 1)
Use of current guidelines
Multi-select from defined list; Likert scales; Numerical
Likert scales:
1=Not at all Relevant, 7=Extremely Relevant
Measured: At the time of survey response (Day 1)
Barriers in guideline adoption
Multi-select from defined list; Likert scales; Numerical
Likert scales:
1=Doesn't impact at all, 7=Greatly impacts
Measured: At the time of survey response (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start24 Mar 2023
- Primary completion12 Sep 2023
- Study completion12 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Steatohepatitis (MASH)Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 675 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765890
- Sponsor's protocol ID
- DAS-7671
- Other IDs
- U1111-1284-5875
- Acronym
- BARRIERS-MASLD
- Status last verified
- Oct 2023
- First submitted
- 14 Feb 2023
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barriers to MASLD Management in Europe: Findings From a Multidisciplinary HCP-survey
- ClinicalTrials.gov ID
- NCT05765890
- Acronym / sponsor ID
- BARRIERS-MASLD / DAS-7671
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 675 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 24 Mar 2023 (actual)
- Primary completion
- 12 Sep 2023 (actual)
- Study completion
- 12 Sep 2023 (actual)
- First posted
- 13 Mar 2023 (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 purpose of this study is to better understand the main barriers to earlier diagnosis and better management of MASLD/MASH patients and to understand the key barriers to adoption of guidelines.
This study is a cross-sectional design, conducted across 5 countries in Europe- France, Germany, Spain, United Kingdom (UK), Italy. Study participants, Hepatologists and other metabolically focused healthcare providers (HCPs), will be recruited to complete a 15 minute self-administered online survey.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hepatologists | – | Other: No treatment givenRecruited via email through online panel companies with which respondents have provided permission to be contacted for research purposes |
| Metabolically-Focused HCPs | – | Other: No treatment givenRecruited via email through online panel companies with which respondents have provided permission to be contacted for research purposes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Hepatologists and other metabolically focused healthcare providers (HCPs)
Key inclusion criteria (14 listed)
- Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
- Male or female, age above or equal to 18 years at the time of signing informed consent.
- Is a physician
- Lives in UK, France, Germany, Italy or Spain
- Primary medical specialty is:
Key exclusion criteria (3 listed)
- Previous participation in this study. Participation is defined as having given informed consent in this study
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Does not meet inclusion criteria requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No treatment givenNo treatment given | Other | Hepatologists, Metabolically-Focused HCPs |
Primary outcome
Unaided awareness
Time frame: At the time of survey response (Day 1)
Open ended response
Aided awareness
Time frame: At the time of survey response (Day 1)
Multi- select from defined list
Behaviours relative to diagnosing and managing MASLD
Time frame: At the time of survey response (Day 1)
Numerical, multi-select from defined list
Use of current guidelines
Time frame: At the time of survey response (Day 1)
Multi-select from defined list; Likert scales; Numerical Likert scales: 1=Not at all Relevant, 7=Extremely Relevant
Barriers in guideline adoption
Time frame: At the time of survey response (Day 1)
Multi-select from defined list; Likert scales; Numerical Likert scales: 1=Doesn't impact at all, 7=Greatly impacts
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Individual participant dataSharing planned: Yes. "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
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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. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-alcoholic Steatohepatitis (MASH) and Non-alcoholic Fatty Liver Disease (MASLD), run by Novo Nordisk A/S at 1 site in India.
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 14 inclusion and 3 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: finished, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unaided awareness (time frame: At the time of survey response (Day 1)). The study lists 5 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 11 Oct 2023.