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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| End-stage liver disease (ESLD) patients | These potential liver transplant candidates are patients with end-stage liver disease (ESLD) who have been assigned to the liver transplant waitlist. |
| |
| Caregivers of potential liver transplant candidates | They are the primary caregivers for the patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prehabilitation intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | From baseline through 3 months |
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Inclusion Criteria:
Liver transplant (LT) candidates are:
Caregivers:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Haiyan Qu, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
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).
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| ID | Term |
|---|---|
| D058625 | End Stage Liver Disease |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| Caregiver intervention | Behavioral | The investigators will provide caregivers with variety of educational resources for patients experiencing ESLD. |
|
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |