Trial Outcomes & Findings for LIFT Intervention in Liver Transplant Candidates (NCT NCT04836923)

The study team proposed to employ a "Realistic Effort Action Planning" (REAP) intervention, which is a form of personality-informed motivational interviewing, in a subset of patients to determine if this enhances the LIFT intervention. Due to funding and time restrictions, the study team was unable to employ this intervention and focused solely on the LIFT intervention. The record has been revised appropriately and these details have also been provided in the Limitations section.

LIFT Intervention in Liver Transplant Candidates

Frailty is described as a biologic syndrome of decreased physiologic reserve and increased vulnerability to health stressors. This outcome is measured by the Liver frailty index \[LFI\]. LFI is composed of 3 performance-based tests (grip strength, chair stands, and balance). Patients are classified using established cutoffs (frail: LFI ≥ 4.5, pre-frail: LFI 3.3-4.4, robust: LFI ≤ 3.2). Higher LFI scores indicate a higher degree of frailty.

Patient-reported physical quality of life was measured using a validated patient-reported outcome measure (Patient-Reported Outcomes Measurement Information System Physical Function \[PROMIS-PF\]) completed in clinic. Patient-reported physical function was measured using a validated patient-reported outcome measure: Patient-Reported Outcomes Measurement Information System Physical Function \[PROMIS-PF\] Version 2.0 - Short Form 8c. A higher PROMIS T-score represents more of the concept being measured. A score of 50 is the average for the United States general population with a standard deviation of 10. A Physical Function T-score of 60 is one SD better than average. By comparison, a Physical Function T-score of 40 is one SD worse than average. Physical Function T-Scores range from 20.3 to 60.1.

Data continuously collected via TrueCoach smart phone application to document adherence to exercise regimen. If patients are unable to appropriately track adherence on the smart phone application, this data will be collected at weekly videoconference/telephone check-ins detailed below. Exercise adherence rates are defined as the number of completed or attempted exercise days/total exercise days prescribed. Overall, patients were classified as adherent to the exercise regimen if their adherence rate was ≥ 75% and partially adherent if ≥ 50%. Patients were classified as non-adherent if their adherence rate was \< 50%. The mean intervention rate was measured throughout the follow-up period (from enrollment to final assessment) - the mean follow-up time was 259 (±190) days.

Data collected from medical chart for liver related complications including but not limited to diagnosis of: ascites, hepatic encephalopathy, variceal bleeding, hepatorenal syndrome, hepatopulmonary syndrome, infection.