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Liver Education About Pain (LEAP) for Liver Cirrhosis
N/A
Waitlist Available
Led By Shari S Rogal, MD, MPH
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 6-12 months start-to-finish
Awards & highlights
Study Summary
This trial will test a behavior intervention to help patients with liver cirrhosis and chronic pain learn self-management skills.
Eligible Conditions
- Liver Cirrhosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 6-12 months start-to-finish
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 6-12 months start-to-finish
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants attending ≥80% of intervention sessions
Overall Satisfaction
Trial Design
1Treatment groups
Experimental Treatment
Group I: LEAP Intervention ArmExperimental Treatment2 Interventions
Enrolled patients will participate in 12 weekly sessions led by a health coach to learn self-pain management tools and skills. In addition to 6 individual sessions and 6 optional group sessions, participants will complete activities from the LEAP workbook (provided after enrollment), as tracking is a key component of most pain-self management interventions and is intended to address self-regulation. All patients can continue to use other pain management strategies ("usual care") in order to mimic real-life conditions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Liver Education About Pain (LEAP)
2022
N/A
~30
Usual Care
1990
Completed Phase 4
~7700
Find a Location
Who is running the clinical trial?
University of PittsburghLead Sponsor
1,719 Previous Clinical Trials
16,342,311 Total Patients Enrolled
3 Trials studying Liver Cirrhosis
104 Patients Enrolled for Liver Cirrhosis
National Institute on Drug Abuse (NIDA)NIH
2,464 Previous Clinical Trials
2,618,563 Total Patients Enrolled
Shari S Rogal, MD, MPHPrincipal InvestigatorUniversity of Pittsburgh
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The person must be receiving care at a UPMC hepatology clinic.You need to have been experiencing pain for three or more months.
Research Study Groups:
This trial has the following groups:- Group 1: LEAP Intervention Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants is this study limited to?
"Affirmative. The information available on clinicaltrials.gov implies that the research project, which was initially advertised on March 14th 2022, is actively searching for participants to join their experiment. Forty individuals will be accepted at one medical centre."
Answered by AI
Are there any spots still available for the clinical trial?
"As confirmed by clinicaltrials.gov, this medical research is presently recruiting participants. The original posting was on March 14th 2022 and the details were amended most recently on April 5th 2022."
Answered by AI
Who else is applying?
What state do they live in?
Ohio
How old are they?
18 - 65
What site did they apply to?
University of Pittsburgh Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
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