An observational study in Liver Transplant; Complications, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 19 Years to 74 Years. Per ClinicalTrials.gov, last updated 2023-05-01.
Sponsored by University of Alabama at Birmingham · Observational
The purpose of this study is to formally identify patient and caregiver perceived needs, barriers, and facilitators to inform the development of a home-based multimodal prehabilitation program for potential LT candidates.
After being informed about the study and potential risks, all participants (patients and caregivers) giving written informed consent will be invited to participate in one of three research activities: interviews (n=10), nominal group technique meetings (n=64), or card-sorting and rating survey (n=40).
University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
This study will include adult, all gender, and all race patients with end-stage liver disease (ESLD) who have been assigned to the liver transplant (LT) waitlist. Nationally, the median age of LT candidates is 57 (48, 63) during 2014 to 2018. UAB Liver Transplant Center technically does not limit patients over 75 years old for LT (i.e., age alone is not an absolute contraindication), but typically as patients age they have less physiologic reserve to tolerate transplant so they must have a better pre-transplant functional status than a younger patient in order to have a good outcome post-transplant. Participants will be identified and recruited from the UAB Liver Transplant Center using a purposive maximum variation sampling approach in terms of age, gender, race, and severity of ESLD.
Liver transplant (LT) candidates are:
Caregivers:
Exclusion Criteria:
These potential liver transplant candidates are patients with end-stage liver disease (ESLD) who have been assigned to the liver transplant waitlist.
Behavioral: Prehabilitation intervention
They are the primary caregivers for the patients.
Behavioral: Caregiver intervention
The investigators will identify participants' perceived important information to develop a prehabilitation intervention in this study. Prehabilitation intervention consisting of physical activities, nutrition, and stress management.
The investigators will provide caregivers with variety of educational resources for patients experiencing ESLD.
Liver frailty index (LFI) score
Change from baseline in liver frailty index score at 3 months; the higher LFI scores indicate a higher degree of frailty. LFI\<3.2: robust, LFI=3.2-4.4: prefrail, LFI\>=4.5: Frail.
Time frame: From baseline through 3 months
Caregiver burden measured using Zarit Burden Interview short form (ZBI-12)
Change from baseline in the total ZBI-12 scores at 3 months. The total ZBI-12 score is the summation of 12 items, ranging from 0 to 48; the higher scores indicate higher burden (0-10:no to mild burden; 10-20: mild to moderate burden), and \>20: high burden.
Time frame: From baseline through 3 months
Plan to share: No — The nominal group technique meeting data will be shared in an aggregate level by group. The card-sorting data and rating data will be shared in an aggregate level by participant type (patient vs caregiver).
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Alabama at Birmingham