- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02877602
Patient Understanding of LiverMultiScan
January 11, 2018 updated by: Perspectum
This is a qualitative study to determine which factors affect the patient experience of having a liver MRI, what information patients would like to receive after their MRI, and how patients would like this information communicated to them.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a qualitative study to determine which factors affect the patient experience of having a liver MRI, what information patients would like to receive after their MRI, and how patients would like this information communicated to them.
Each individual will receive at least an MRI scan (LiverMultiScan), with many also receiving a FibroScan (Transient Elastography).
Patients will then undergo a focused qualitative interview, as well as filling out a questionnaire.
The interviews will be thematically analysed and trends identified by significance.
Study Type
Observational
Enrollment (Actual)
101
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oxfordshire
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Oxford, Oxfordshire, United Kingdom, OX3 9DU
- University of Oxford Centre for Clinical Magnetic Resonance Research (OCMR)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Individuals with experience of liver disease, either as a sufferer or carer.
Description
Inclusion Criteria:
- Individuals with experience of liver disease.
- Individuals over the age of 16.
- Individuals willing to give informed consent for participation in the study.
Exclusion Criteria:
- Individuals with any contraindication to magnetic resonance imaging.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Experience of liver disease
This is defined as either those who have had direct experience of liver disease as sufferers, or the carers of those who have had liver disease.
Each individual receives an MRI (LiverMultiScan), with many also receiving a FibroScan.
|
Other Names:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Factors effecting MRI experience and understanding.
Time Frame: Immediately (within 1 hour) after undergoing the MRI scan, and receiving results feedback.
|
This will be analysed based on themes and trends emanating from answers within the focused interview and questionnaire following the scan, and results feedback.
|
Immediately (within 1 hour) after undergoing the MRI scan, and receiving results feedback.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of MRI to ultrasound scan in terms of patient experience.
Time Frame: Immediately (within 1 hour) after undergoing an MRI scan, and ultrasound (FibroScan) scan.
|
This will be analysed based on themes and trends emanating from answers within the focused interview and questionnaire following the scan, and results feedback.
|
Immediately (within 1 hour) after undergoing an MRI scan, and ultrasound (FibroScan) scan.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rajarshi Banerjee, BM BCh MRCP MSc DPhil, Perspectum Diagnostics
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2016
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
August 17, 2016
First Submitted That Met QC Criteria
August 19, 2016
First Posted (Estimate)
August 24, 2016
Study Record Updates
Last Update Posted (Actual)
January 12, 2018
Last Update Submitted That Met QC Criteria
January 11, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Patient LMS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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