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LiveSMART Trial to Prevent Falls in Patients With Cirrhosis

Primary Purpose

Cirrhosis, Liver, Portal Hypertension

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Enhanced Usual Care
Lactulose
Investigator recommended exercise
TeleTai-Chi (virtual)
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cirrhosis, Liver focused on measuring Exercise program, Lactulose, Tai-Chi, Fall prevention, Dietary Protein

Eligibility Criteria

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

Inclusion Criteria: Clinical diagnosis of cirrhosis based on histology and/or imaging specified in the protocol. Evidence of portal hypertension - must meet at least one of the following criteria: Ascites (present or within past 2 years) Varices (seen by Esophagogastroduodenoscopy or by Ultrasound or cross-sectional imaging) Fibroscan Liver stiffness measurement (LSM) >25 kilopascals (kPa) (if no other factors present) Magnetic resonance elastography (MRE) LSM > 5 kPa (if no other factors present) Acoustic radiation force impulse LSM > 17kpa (if no other factors present) Hepatic vein pressure gradient > 10 millimetres of mercury (mmHg) Portal hypertensive gastropathy seen on Esophagogastroduodenoscopy Platelet count < 80/ units per liter (uL) Access to Wireless Fidelity (Wi-Fi) at home Owns or access to a smartphone, tablet or computer English or Spanish speaking Willing to participate in exercise program Exclusion Criteria: Overt hepatic encephalopathy (HE) within 6 months, requiring >28 days of lactulose Took lactulose for non - HE reasons for >28 days in last 6 months Model for End Stage Liver Disease (MELD) > 25 (Exception: MELD > 25 with clinically stable End-Stage Renal Disease (ESRD) for whom the bilirubin is < 5 g/dL) Barcelona Clinic Liver Cancer (BCLC) > C Hepatocellular Carcinoma (HCC) Currently taking Sorafenib, Atezolizumab/Bevacizumab, Regorafinib, or Cabozatinib Greater than (>) 3 paracentesis/month in last 2 months Active Metastatic solid malignancy or acute leukemia within last 3 years Severe cognitive, vision, or hearing impairment (without use of corrective lenses or hearing assist devices) or psychiatric illness precluding study participation Currently participates in Tai-Chi or performs >150 min/week vigorous physical activity Currently receiving physical therapy Living in an assisted living facility Hemoglobin A1C > 12 (within past 12 months) Requires a low galactose diet Deemed unsuitable by the study investigator

Sites / Locations

  • University of MichiganRecruiting
  • University of PennsylvaniaRecruiting
  • Baylor Scott & White Research Institute (BSW)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Enhanced usual care group

Treatment (Lactulose) group plus enhanced usual care

Enhanced usual care group followed by investigator recommended exercise

Treatment (Lactulose) plus enhanced usual care then TeleTai-Chi exercise classes

Enhanced usual care group followed by Tele-Tai Chi exercise classes

Treatment (Lactulose) plus enhanced usual care then recommended exercise

Arm Description

Participants will be in stage 1 for approximately 12 weeks and then be re-evaluated. Participation will end the study if not qualified for 2nd stage.

Participants will be in stage 1 for approximately 12 weeks and then be re-evaluated. Participation will end the study if not qualified for 2nd stage.

This is considered stage 2 for 12 weeks (for eligible re-randomized participants).

This is considered stage 2 for 12 weeks (for eligible re-randomized participants)

This is considered stage 2 for 12 weeks (for eligible re-randomized participants)

This is considered stage 2 for 12 weeks (for eligible re-randomized participants)

Outcomes

Primary Outcome Measures

A hierarchical composite of events over 24 weeks: injurious falls, non-injurious falls, incident Hepatic Encephalopathy, and death/transplant
Composite outcome is defined as any of the following: Injurious Fall: Fracture, dislocation, cut, head injury, soft - tissue injury requiring hospitalization Non - Injurious Fall: Inadvertently coming to rest on the floor or lower level Incident Overt HE: Acute disorientation requiring hospitalization or the initiation of HE - directed therapy, confirmed by a gastroenterologist or study investigator Death: Mortality with any cause

Secondary Outcome Measures

Cognitive Function based on the Animal Naming Test (ANT)
The animal naming test assesses cognitive function. It is a timed test that that consists of participants listing as many unique animals as possible in 60 seconds. This is a validated test used for the assessment of hepatic encephalopathy. The score is the number of unique animals stated (higher is better).
Days-alive and out-of-the-hospital
Days-alive and out-of-the-hospital is a continuous value, 1 for each day alive, 0 for days in hospital. Participants will be queried and data will also be abstracted from the Electronic Medical Record (EMR).
Injurious Falls
Falls include: Fracture, dislocation, cut, head injury, soft - tissue injury requiring hospitalization.
Non-Injurious Falls
Non- Injurious Falls include: Inadvertently coming to rest on the floor or lower level
Incident Overt hepatic encephalopathy (HE)
Incident Overt HE includes: Acute disorientation requiring hospitalization or the initiation of HE - directed therapy, confirmed by a gastroenterologist or study investigator.
Death/transplant
Mortality with any cause or liver transplantation

Full Information

First Posted
March 20, 2023
Last Updated
September 8, 2023
Sponsor
University of Michigan
Collaborators
Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05794555
Brief Title
LiveSMART Trial to Prevent Falls in Patients With Cirrhosis
Official Title
LiveSMART: A Sequential, Multiple Assignment Randomized Trial to Prevent Falls in Patients With Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 13, 2023 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
This multicenter trial is being conducted to determine if sequential lactulose and Tele (virtual) Tai-Chi reduces the rate of injurious fall, non-injurious falls, incident overt Hepatic Encephalopathy (HE), and death. Participants that are enrolled will be randomized to stage one of this project for approximately 12 weeks. After completing stage one, participants will be re-evaluated and if eligible will be re-randomized to stage 2 of the project that will last approximately 12 more weeks. The study hypothesizes that sequential lactulose/TeleTai-Chi will reduce falls, incident overt HE, death and physical frailty and will improve cognitive function, and Health Related Quality of Life (HRQOL) over 24 weeks compared to other treatment combinations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Liver, Portal Hypertension
Keywords
Exercise program, Lactulose, Tai-Chi, Fall prevention, Dietary Protein

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Sequential Assignment
Model Description
Participants will be randomized in stage 1 to enhanced usual care or enhanced usual care plus lactulose. After 12 weeks participants will be re-evaluated to continue into stage 2 will be re-randomized to TeleTai-Chi (at-home, via Zoom, supervised by a study team instructor) vs. continued enhanced usual care. The participants that took lactulose in Stage 1 will continue to take lactulose through Stage 2 until their participation is complete.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
215 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enhanced usual care group
Arm Type
Active Comparator
Arm Description
Participants will be in stage 1 for approximately 12 weeks and then be re-evaluated. Participation will end the study if not qualified for 2nd stage.
Arm Title
Treatment (Lactulose) group plus enhanced usual care
Arm Type
Experimental
Arm Description
Participants will be in stage 1 for approximately 12 weeks and then be re-evaluated. Participation will end the study if not qualified for 2nd stage.
Arm Title
Enhanced usual care group followed by investigator recommended exercise
Arm Type
Active Comparator
Arm Description
This is considered stage 2 for 12 weeks (for eligible re-randomized participants).
Arm Title
Treatment (Lactulose) plus enhanced usual care then TeleTai-Chi exercise classes
Arm Type
Experimental
Arm Description
This is considered stage 2 for 12 weeks (for eligible re-randomized participants)
Arm Title
Enhanced usual care group followed by Tele-Tai Chi exercise classes
Arm Type
Experimental
Arm Description
This is considered stage 2 for 12 weeks (for eligible re-randomized participants)
Arm Title
Treatment (Lactulose) plus enhanced usual care then recommended exercise
Arm Type
Experimental
Arm Description
This is considered stage 2 for 12 weeks (for eligible re-randomized participants)
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Usual Care
Intervention Description
Patients will be provided and counseled on two methods which will enhance care. The first is a handout on nutrition recommendations and protein supplementation. This will include the recommendation of both high protein snacks during the daytime (e.g., protein bars) and a high-protein night-time snack (e.g., peanut butter and crackers). The second will be to counsel participants on falls prevention methods that can be enacted in day-to-day life. All participants will be provided with a standard hand-out of Centers for Disease Control and Prevention (CDC)-endorsed fall-risk reduction measures.
Intervention Type
Drug
Intervention Name(s)
Lactulose
Intervention Description
Patients will be prescribed lactulose and will also receive enhanced usual care. Lactulose will be taken on a specific schedule based on the average number of bowel movements on average per day. It will be started at 15 milliliter (mL) dose and will be instructed to slowly increase the lactulose dose over the course of the first week of Stage 1 participation. The prescribed maximum dose will be 30 mL (20g) twice daily. The dose will slowly increase toward the maximum or until participants reach 2-3 soft bowel movements daily. Participants that receive Lactulose during stage 1 will continue this in stage 2 (if re-randomized).
Intervention Type
Behavioral
Intervention Name(s)
Investigator recommended exercise
Intervention Description
Participants randomized to enhanced usual care will be reminded of standard fall precautions outlined in the Fall Prevention Primer that were provided in Stage 1 and will receive exercise recommendations.
Intervention Type
Behavioral
Intervention Name(s)
TeleTai-Chi (virtual)
Intervention Description
TeleTai-Chi will be taught remotely via live Zoom classes of up to 15 patients by a certified TeleTai-Chi instructor three times per week (for approximately 12 weeks). Classes will be conducted via a HIPAA-compliant Zoom server through the University of Michigan. Participants will be instructed to use Zoom by smartphone, tablet, or computer. High-Definition Multimedia Interface (HDMI) cables to connect devices to televisions will be provided.
Primary Outcome Measure Information:
Title
A hierarchical composite of events over 24 weeks: injurious falls, non-injurious falls, incident Hepatic Encephalopathy, and death/transplant
Description
Composite outcome is defined as any of the following: Injurious Fall: Fracture, dislocation, cut, head injury, soft - tissue injury requiring hospitalization Non - Injurious Fall: Inadvertently coming to rest on the floor or lower level Incident Overt HE: Acute disorientation requiring hospitalization or the initiation of HE - directed therapy, confirmed by a gastroenterologist or study investigator Death: Mortality with any cause
Time Frame
Baseline to 24 weeks (following stage 2)
Secondary Outcome Measure Information:
Title
Cognitive Function based on the Animal Naming Test (ANT)
Description
The animal naming test assesses cognitive function. It is a timed test that that consists of participants listing as many unique animals as possible in 60 seconds. This is a validated test used for the assessment of hepatic encephalopathy. The score is the number of unique animals stated (higher is better).
Time Frame
Baseline to 24 weeks (following stage 2)
Title
Days-alive and out-of-the-hospital
Description
Days-alive and out-of-the-hospital is a continuous value, 1 for each day alive, 0 for days in hospital. Participants will be queried and data will also be abstracted from the Electronic Medical Record (EMR).
Time Frame
Baseline to 24 weeks (following stage 2)
Title
Injurious Falls
Description
Falls include: Fracture, dislocation, cut, head injury, soft - tissue injury requiring hospitalization.
Time Frame
Baseline to 24 weeks (following stage 2)
Title
Non-Injurious Falls
Description
Non- Injurious Falls include: Inadvertently coming to rest on the floor or lower level
Time Frame
Baseline to 24 weeks (following stage 2)
Title
Incident Overt hepatic encephalopathy (HE)
Description
Incident Overt HE includes: Acute disorientation requiring hospitalization or the initiation of HE - directed therapy, confirmed by a gastroenterologist or study investigator.
Time Frame
Baseline to 24 weeks (following stage 2)
Title
Death/transplant
Description
Mortality with any cause or liver transplantation
Time Frame
Baseline to 24 weeks (following stage 2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of cirrhosis based on histology and/or imaging specified in the protocol. Evidence of portal hypertension - must meet at least one of the following criteria: Ascites (present or within past 2 years) Varices (seen by Esophagogastroduodenoscopy or by Ultrasound or cross-sectional imaging) Fibroscan Liver stiffness measurement (LSM) >25 kilopascals (kPa) (if no other factors present) Magnetic resonance elastography (MRE) LSM > 5 kPa (if no other factors present) Acoustic radiation force impulse LSM > 17kpa (if no other factors present) Hepatic vein pressure gradient > 10 millimetres of mercury (mmHg) Portal hypertensive gastropathy seen on Esophagogastroduodenoscopy Platelet count < 80/ units per liter (uL) Access to Wireless Fidelity (Wi-Fi) at home Owns or access to a smartphone, tablet or computer English or Spanish speaking Willing to participate in exercise program Exclusion Criteria: Overt hepatic encephalopathy (HE) within 6 months, requiring >28 days of lactulose Took lactulose for non - HE reasons for >28 days in last 6 months Model for End Stage Liver Disease (MELD) > 25 (Exception: MELD > 25 with clinically stable End-Stage Renal Disease (ESRD) for whom the bilirubin is < 5 g/dL) Barcelona Clinic Liver Cancer (BCLC) > C Hepatocellular Carcinoma (HCC) Currently taking Sorafenib, Atezolizumab/Bevacizumab, Regorafinib, or Cabozatinib Greater than (>) 3 paracentesis/month in last 2 months Active Metastatic solid malignancy or acute leukemia within last 3 years Severe cognitive, vision, or hearing impairment (without use of corrective lenses or hearing assist devices) or psychiatric illness precluding study participation Currently participates in Tai-Chi or performs >150 min/week vigorous physical activity Currently receiving physical therapy Living in an assisted living facility Hemoglobin A1C > 12 (within past 12 months) Requires a low galactose diet Deemed unsuitable by the study investigator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samantha Nikirk
Phone
734-232-4182
Email
samjwalk@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elliott Tapper, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marina Serper, MD, MS
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samantha Nikirk
Phone
734-232-4182
Email
samjwalk@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Elliott Tapper, MD
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alex Burdzy
Phone
215-662-3904
Email
Alex.Burdzy@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Ethan Weinberg, MD
Facility Name
Baylor Scott & White Research Institute (BSW)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Roy
Phone
214-820-1768
Email
Angela.Roy@BSWHealth.org
First Name & Middle Initial & Last Name & Degree
Sumeet Asrani, MD

12. IPD Sharing Statement

Learn more about this trial

LiveSMART Trial to Prevent Falls in Patients With Cirrhosis

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