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Patient Understanding of LiverMultiScan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02877602
Recruitment Status : Completed
First Posted : August 24, 2016
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Perspectum

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Liver Diseases Device: MRI Device: Transient Elastography

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 Design
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Study Type : Observational
Actual Enrollment : 101 participants
Observational Model: Other
Time Perspective: Other
Official Title: Patient Understanding of LiverMultiScan
Actual Study Start Date : February 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases

Groups and Cohorts
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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.
 Device: MRI
Other Name: LiverMultiScan

Device: Transient Elastography
Other Name: FibroScan


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Individuals with experience of liver disease, either as a sufferer or carer.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02877602


Locations
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United Kingdom
University of Oxford Centre for Clinical Magnetic Resonance Research (OCMR)
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Sponsors and Collaborators
Perspectum
Investigators
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Principal Investigator: Rajarshi Banerjee, BM BCh MRCP MSc DPhil Perspectum Diagnostics
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Perspectum
ClinicalTrials.gov Identifier: NCT02877602    
Other Study ID Numbers: Patient LMS
First Posted: August 24, 2016    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases