Cirrhosis of the LiverLowMELDNCT01573325
HRQoL in the Low MELD Pre-tx Population
An observational study of Cirrhosis of the Liver, run by Northwestern University.
Trial summary
The purpose of this study is to describe the HRQoL in those with MELD scores </= 15 in a single center for those who are pre-liver transplant candidates Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cirrhosis of the Liver
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Jul 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Study population: Adults who are a candidate for a liver transplant at Northwester Memorial Hospital with MELD score </=15
Who may be able to join
- Must be a patient in the liver transplant clinic at Northwestern Memorial Hospital or one of its satellite clinics (including Washington, Illinois; Portage, Indiana; Glenview, Illinois, Oakbrook, Illinois; Joliet, Illinois)
- Adult patient between the ages of 18-75
- Ability to read and speak English
- Must be a candidate for liver transplant per Northwestern Memorial Hospital liver transplant multidisciplinary committee
- Model for End Stage Liver Disease (MELD) score ≤15
- Cognitive ability to complete measures
Who cannot join
- Non-English speaking
- Those who have already received a liver transplant
- Hepatic encephalopathy as evidenced by:
- Grade II or more West Haven Criteria or Adapted West Haven Criteria
- Evidence of Asterixis upon exam at time of consent (if consented in person)
- Acute liver failure as etiology for liver disease.
- MELD score > 15
- Mental retardation or cognitive disabilities preventing completion of the written questionnaire
About this study
Official title: Health-Related Quality of Life in the Low Model for End-Stage Liver Disease (MELD) Pre Transplant Patient Candidate: A Pilot Study
The purpose of this study is to describe the HRQoL in those with MELD scores </= 15 in a single center for those who are pre-liver transplant candidates
Read the detailed description
The liver organ allocation system was significantly revised in 2002, allowing a more objective prioritization of liver transplant candidates. The revised Model for End Stage Liver Disease (MELD) system is based primarily on laboratory test results. Candidates with MELD scores of less than 15 are considered to be low priority for cadaveric liver transplant and have limited treatment options. Yet patients with low MELD scores may suffer from an array of symptoms associated with liver disease such as fatigue, sleep disturbances, and depression - all of which erode health-related quality of life (HRQoL). No previous studies were found that examined HRQoL in low MELD transplant patients. A better understanding of the HRQoL of these patients will allow clinicians to better meet their needs. Therefore, the aims of the proposed pilot capstone project are to examine HRQoL and to identify demographic and clinical characteristics including liver-disease related symptoms, functional status, perceived social support, biological functioning and mental health associated with HRQoL in pre-liver transplant candidates with low MELD scores. The revised Wilson and Cleary Quality of Life Model will be used to guide the project. Fifty pre-transplant liver candidates with MELD scores < 15 will be enrolled in the descriptive, cross-sectional pilot study. Participants will complete a written questionnaire measuring perceived HRQoL and clinical characteristics. Descriptive and correlational statistics will be used to analyze the data. Findings from this project will identify trends in factors that contribute to a HRQoL of this population and provide the foundation for a larger future project.
- Conditions
- Cirrhosis of the Liver
- Keywords
- Cirrhosis of the liver, Pre-liver transplant Candidate, Depression, Poor social support, Liver disease symptoms, Health releated quality of life
- Medical subject headings
- Fibrosis, Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived HRQoL Score. Overall Qualty of Life Index Tool Was Utilized.
Describe perceived HRQoL in patients with low MELD scores (≤15) pre-liver transplant patient population. Overall Qualty of Life Index tool was utilized. The subscales were not utilized. The unit of measurement was scores on a scale. QLI tool has a range of 0-30 for total possible score. With the higher the score the higher the HRQoL.
Measured: 2-3 months
Secondary outcomes (1)
Percentage of Subjects With Depressive Scores Who Had a Poor HRQoL
Identify clinical characteristics such as environmental factors, patient biology, liver-disease related symptoms, functional status, general health perception, characteristics of the individual associated with perceived HRQoL in patients with low MELD scores (≤15) pre-transplant. What characteristics were found to be predictive of poor HRQoL. Tools utilized each assessed the specific variables including patient biology, liver disease symptoms, functional status, general health perception, and characteristics of the individual.
Measured: 2-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cirrhosis of the LiverStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Loyola University
- Responsible party
- Principal investigator, Rebecca Duke, Northwestern University
- Investigators
- Rebecca Duke, MSN, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01573325
- Sponsor's protocol ID
- STU00060397
- Acronym
- LowMELD
- Status last verified
- Feb 2014
- First submitted
- 5 Apr 2012
- Last updated
- 28 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-Related Quality of Life in the Low Model for End-Stage Liver Disease (MELD) Pre Transplant Patient Candidate: A Pilot Study
- ClinicalTrials.gov ID
- NCT01573325
- Acronym / sponsor ID
- LowMELD / STU00060397
- Conditions
- Cirrhosis of the Liver
- Keywords
- Cirrhosis of the liver, Pre-liver transplant Candidate, Depression, Poor social support, Liver disease symptoms, Health releated quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Loyola University
- Study start
- Mar 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 9 Apr 2012 (estimated)
- Results
- Posted 28 Feb 2014
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 describe the HRQoL in those with MELD scores </= 15 in a single center for those who are pre-liver transplant candidates
Detailed description
The liver organ allocation system was significantly revised in 2002, allowing a more objective prioritization of liver transplant candidates. The revised Model for End Stage Liver Disease (MELD) system is based primarily on laboratory test results. Candidates with MELD scores of less than 15 are considered to be low priority for cadaveric liver transplant and have limited treatment options. Yet patients with low MELD scores may suffer from an array of symptoms associated with liver disease such as fatigue, sleep disturbances, and depression - all of which erode health-related quality of life (HRQoL). No previous studies were found that examined HRQoL in low MELD transplant patients. A better understanding of the HRQoL of these patients will allow clinicians to better meet their needs. Therefore, the aims of the proposed pilot capstone project are to examine HRQoL and to identify demographic and clinical characteristics including liver-disease related symptoms, functional status, perceived social support, biological functioning and mental health associated with HRQoL in pre-liver transplant candidates with low MELD scores. The revised Wilson and Cleary Quality of Life Model will be used to guide the project. Fifty pre-transplant liver candidates with MELD scores < 15 will be enrolled in the descriptive, cross-sectional pilot study. Participants will complete a written questionnaire measuring perceived HRQoL and clinical characteristics. Descriptive and correlational statistics will be used to analyze the data. Findings from this project will identify trends in factors that contribute to a HRQoL of this population and provide the foundation for a larger future project.
Study design
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults who are a candidate for a liver transplant at Northwester Memorial Hospital with MELD score </=15
Key inclusion criteria (6 listed)
- Must be a patient in the liver transplant clinic at Northwestern Memorial Hospital or one of its satellite clinics (including Washington, Illinois; Portage, Indiana; Glenview, Illinois, Oakbrook, Illinois; Joliet, Illinois)
- Adult patient between the ages of 18-75
- Ability to read and speak English
- Must be a candidate for liver transplant per Northwestern Memorial Hospital liver transplant multidisciplinary committee
- Model for End Stage Liver Disease (MELD) score ≤15
Key exclusion criteria (8 listed)
- Non-English speaking
- Those who have already received a liver transplant
- Hepatic encephalopathy as evidenced by:
- Acute liver failure as etiology for liver disease.
- MELD score > 15
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
Perceived HRQoL Score. Overall Qualty of Life Index Tool Was Utilized.
Time frame: 2-3 months
Describe perceived HRQoL in patients with low MELD scores (≤15) pre-liver transplant patient population. Overall Qualty of Life Index tool was utilized. The subscales were not utilized. The unit of measurement was scores on a scale. QLI tool has a range of 0-30 for total possible score. With the higher the score the higher the HRQoL.
1 secondary outcome
Percentage of Subjects With Depressive Scores Who Had a Poor HRQoL
Time frame: 2-3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Rebecca Duke, MSN principal investigator
Northwestern University
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis of the Liver, run by Northwestern University.
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 6 inclusion and 8 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 28 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 28 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Perceived HRQoL Score. Overall Qualty of Life Index Tool Was Utilized. (time frame: 2-3 months). 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 28 Feb 2014.