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LIFT Intervention in Liver Transplant Candidates

Primary Purpose

Frailty, Cirrhosis, Liver Transplant

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
"LIver FrailTy" intervention (LIFT)
"Realistic Effort Action Planning" intervention (REAP)
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Frailty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with a diagnosis of liver cirrhosis being evaluated for liver transplantation in hepatology/transplant evaluation clinic
  • English-speaking
  • Patients with access to a smart phone (with videoconference capabilities)
  • Vulnerable populations: We will include patients who are cognitively impaired due to hepatic encephalopathy and unable to consent for themselves.

Exclusion Criteria:

  • Patients < 18 years of age
  • Patients who require outpatient physical therapy.
  • Patients without the ability to consent for themselves or through a medical power of attorney.

Sites / Locations

  • Northwestern MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

LIFT subgroup

LIFT + REAP subgroup

Arm Description

PT evaluation, an individualized home exercise prescription (HEP), daily text message reminders to exercise and weekly telephone check-ins with team members.

PT evaluation, an individualized home exercise prescription (HEP), daily text message reminders to exercise and weekly telephone check-ins with team members. We will also employ "Realistic Effort Action Planning" (REAP), a form of personality-informed motivational interviewing in a subset of patients to potentially enhance patient engagement and adherence to the home-exercise prescription.

Outcomes

Primary Outcome Measures

Frailty
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). There is no data to date describing the expected range of values. Higher LFI scores indicate a higher degree of frailty.
Placement on liver transplant waitlist
A clinical measure for the participant and where they are located on the liver transplant waiting list.
Clinical Outcomes - waitlist / post-transplant mortality
Measured if a patient dies while listed on the transplant waitlist or post-transplant.
Clinical Outcomes - post transplant disposition
Determined by location of patient after transplant (can be listed such as acute rehabilitation, subacute rehabilitation center, home, etc.)
Clinical Outcomes - number and duration of hospitalizations
Clinical measure for how many times a patient is hospitalized and how long those hospitalizations last.
Clinical Outcomes - liver related complications
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.

Secondary Outcome Measures

Endurance
Measured by the 4-meter walk test. Longer gait speeds suggest an increased risk of frailty.
Patient adherence
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.
Degree of hepatic encephalopathy
Measured by List Sort Working Memory [LSWM] test, the Flanker Inhibitory Control and Attention [FICA], and Pattern Comparison Processing Speed Test (PCPS). LSWM consists of several trials wherein complementary visual and audio stimuli, presented one at a time, and participants are asked to repeat the items in order of size from smallest to largest. The raw score is the total number of lists repeated correctly. A higher score is associated with better outcomes. FICA examines patients' ability to inhibit visual attention to distractor arrows (flankers) and focus on a central stimulus arrow. The raw score is calculated from the response accuracy and response time over 40 trials. A higher score is associated with better outcomes. PCPS assesses choice reaction time by asking patients to determine whether two visual patterns are identical by "Yes" or "No". The raw score is the total correct responses out of 130. A higher score is associated with better outcomes.
Patient-reported quality of life
Patient-reported quality of life is measured through a series of questionnaires a participant completes at baseline and every three months for up to five years. This outcome is measured by the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Toolkit using the following validated questionnaires: Global Health Scale version 1.2, Physical Function - Short Form 8c version 2.0, Cognitive Function version 2.0, Pain Interference version 1.1, Dyspnea Severity version 1.0, Meaning and Purpose version 1.0, Fatigue version 1.0, Ability to Participate in Social Roles and Activities version 2.0. Each survey uses a 5-point Likert scale. Higher scores generally indicate poor quality of life.
Personality assessment
This outcome is measured using the Modified Midlife Development Inventory (MIDI) Personality Scale. MIDI is a list of 21 adjectives that the respondent is asked to use to rate themselves, on a four-point scale, ranging from "not at all" to "a little," "some," and "a lot."

Full Information

First Posted
April 5, 2021
Last Updated
February 10, 2023
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT04836923
Brief Title
LIFT Intervention in Liver Transplant Candidates
Official Title
Home-based Physical Therapy Intervention to Decrease Frailty in Liver Transplant Candidates
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Frailty is a significant problem in patients undergoing liver transplant and is associated with poor outcomes and survival. Hence, optimizing physical fitness and counteracting frailty is important. However, many interventions are very resource intensive and therefore not feasible. In this study, the investigators aim to test the effectiveness of a newly designed intervention to improve frailty in liver transplant candidates. The "LIver FrailTy" intervention (LIFT) will consist of an evaluation by a physical therapist, an individualized home exercise prescription (HEP), exercise tracking using a smart phone application, daily text reminders to exercise and recurrent telephone check-ins. The investigators also aim to perform "Realistic Effort Action Planning" (REAP), which is a form of personality-informed motivational interviewing, in a subset of patients to determine if this enhances the LIFT intervention.
Detailed Description
Frailty is defined as a biologic syndrome of decreased physiologic reserve and increased vulnerability to health stressors. The concept of frailty has recently emerged as a critical determinant in the field of cirrhosis and liver transplantation. Frailty impacts pre- and post-transplant clinical outcomes, including waitlist mortality, post-transplant mortality, frequency of hospitalizations and duration of hospital admissions. Although the impact of frailty in liver transplantation has been established in the literature, there is a lack of data supporting effective interventions to decrease frailty prior to liver transplantation. Moreover, the studies that have tested interventions to improve physical function have relied on frequent supervised physical therapy sessions and access to exercise equipment that it is not financially or logistically feasible for the majority of patients. Patient engagement in PT also remains a critical barrier to overcome to decrease frailty in preparation for liver transplantation. Developing a practical and effective intervention to consistently engage patients in physical activity and decrease frailty is essential to improving clinical outcomes in the pre- and post-liver transplant setting. The investigators goal is to pilot test a novel PT intervention to decrease frailty in pre-transplant patients. The investigators have designed a prototype "LIver FrailTy" intervention (LIFT) that includes: PT evaluation, an individualized home exercise prescription (HEP), daily text message reminders to exercise and weekly telephone check-ins with team members. The investigators will also employ "Realistic Effort Action Planning" (REAP), a form of personality-informed motivational interviewing in a subset of patients to potentially enhance patient engagement and adherence to the home-exercise prescription. The central hypothesis is that the LIFT (+/- REAP) intervention will 1) improve adherence to recommended levels of exercise in end-stage liver disease 2) reduce pre-transplant frailty and 3) will improve pre- and post-transplant clinical outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty, Cirrhosis, Liver Transplant

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LIFT subgroup
Arm Type
Experimental
Arm Description
PT evaluation, an individualized home exercise prescription (HEP), daily text message reminders to exercise and weekly telephone check-ins with team members.
Arm Title
LIFT + REAP subgroup
Arm Type
Experimental
Arm Description
PT evaluation, an individualized home exercise prescription (HEP), daily text message reminders to exercise and weekly telephone check-ins with team members. We will also employ "Realistic Effort Action Planning" (REAP), a form of personality-informed motivational interviewing in a subset of patients to potentially enhance patient engagement and adherence to the home-exercise prescription.
Intervention Type
Behavioral
Intervention Name(s)
"LIver FrailTy" intervention (LIFT)
Intervention Description
Novel physical therapy intervention to decrease frailty in pre-transplant patients
Intervention Type
Behavioral
Intervention Name(s)
"Realistic Effort Action Planning" intervention (REAP)
Intervention Description
This intervention is an interactive behavioral interviewing process to engage patients in their care
Primary Outcome Measure Information:
Title
Frailty
Description
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). There is no data to date describing the expected range of values. Higher LFI scores indicate a higher degree of frailty.
Time Frame
Every month for up to 5 years
Title
Placement on liver transplant waitlist
Description
A clinical measure for the participant and where they are located on the liver transplant waiting list.
Time Frame
Every month for up to 5 years
Title
Clinical Outcomes - waitlist / post-transplant mortality
Description
Measured if a patient dies while listed on the transplant waitlist or post-transplant.
Time Frame
Every month for up to 5 years
Title
Clinical Outcomes - post transplant disposition
Description
Determined by location of patient after transplant (can be listed such as acute rehabilitation, subacute rehabilitation center, home, etc.)
Time Frame
Every month for up to 5 years
Title
Clinical Outcomes - number and duration of hospitalizations
Description
Clinical measure for how many times a patient is hospitalized and how long those hospitalizations last.
Time Frame
Every month for up to 5 years
Title
Clinical Outcomes - liver related complications
Description
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.
Time Frame
Every month for up to 5 years
Secondary Outcome Measure Information:
Title
Endurance
Description
Measured by the 4-meter walk test. Longer gait speeds suggest an increased risk of frailty.
Time Frame
Every 3 months for up to 5 years
Title
Patient adherence
Description
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.
Time Frame
Every week for up to 5 years
Title
Degree of hepatic encephalopathy
Description
Measured by List Sort Working Memory [LSWM] test, the Flanker Inhibitory Control and Attention [FICA], and Pattern Comparison Processing Speed Test (PCPS). LSWM consists of several trials wherein complementary visual and audio stimuli, presented one at a time, and participants are asked to repeat the items in order of size from smallest to largest. The raw score is the total number of lists repeated correctly. A higher score is associated with better outcomes. FICA examines patients' ability to inhibit visual attention to distractor arrows (flankers) and focus on a central stimulus arrow. The raw score is calculated from the response accuracy and response time over 40 trials. A higher score is associated with better outcomes. PCPS assesses choice reaction time by asking patients to determine whether two visual patterns are identical by "Yes" or "No". The raw score is the total correct responses out of 130. A higher score is associated with better outcomes.
Time Frame
Every 3 months for up to 5 years
Title
Patient-reported quality of life
Description
Patient-reported quality of life is measured through a series of questionnaires a participant completes at baseline and every three months for up to five years. This outcome is measured by the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Toolkit using the following validated questionnaires: Global Health Scale version 1.2, Physical Function - Short Form 8c version 2.0, Cognitive Function version 2.0, Pain Interference version 1.1, Dyspnea Severity version 1.0, Meaning and Purpose version 1.0, Fatigue version 1.0, Ability to Participate in Social Roles and Activities version 2.0. Each survey uses a 5-point Likert scale. Higher scores generally indicate poor quality of life.
Time Frame
Every 3 months for up to 5 years
Title
Personality assessment
Description
This outcome is measured using the Modified Midlife Development Inventory (MIDI) Personality Scale. MIDI is a list of 21 adjectives that the respondent is asked to use to rate themselves, on a four-point scale, ranging from "not at all" to "a little," "some," and "a lot."
Time Frame
Every month for up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with a diagnosis of liver cirrhosis being evaluated for liver transplantation in hepatology/transplant evaluation clinic English-speaking Patients with access to a smart phone (with videoconference capabilities) Vulnerable populations: We will include patients who are cognitively impaired due to hepatic encephalopathy and unable to consent for themselves. Exclusion Criteria: Patients < 18 years of age Patients who require outpatient physical therapy. Patients without the ability to consent for themselves or through a medical power of attorney.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Avesh Thuluvath, MD
Phone
3126940260
Email
avesh.thuluvath@northwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniela Ladner, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amna Daud
Phone
312-695-0427
Email
a-daud@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Avesh Thuluvath, MD
First Name & Middle Initial & Last Name & Degree
Daniela P Ladner, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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LIFT Intervention in Liver Transplant Candidates

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