LiveSMART: A Sequential, Multiple Assignment Randomized Trial to Prevent Falls in Patients With Cirrhosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 233
- 试验地点
- 4
- 主要终点
- Number of patients experiencing a hierarchical composite of events over 24 weeks: injurious falls, non-injurious falls, incident Hepatic Encephalopathy, liver transplant, and death/transplant
研究概览
简要总结
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 or liver transplant over 24 weeks.
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-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.
As detailed below, an observational component that enrolls caregivers of the trial participants is being conducted. Upon completion, Participants listed in the record here only include trial participants; and the observational component was moved to a new registration for clarity, NCT07140120.
详细描述
The Clinicaltrials.gov registration record was updated as requested by Patient-Centered Outcomes Research Institute (PCORI) based on protocol amendment version 3.0 after approval by the Institutional Review Board. These changes included: the additional aim for a supplemental observational study to assess social determinants of health, financial burdens, etc., and includes recruitment of the caregivers for this supplemental study along with the trial participants, as well as updated outcomes for the trial. After further discussion with PCORI, these changes were removed from this record and used to create a separate record for the supplemental study focused on caregivers (NCT07140120).
The caregivers that are enrolled are not in the clinical trial. All clinical trial information is provided in this record, but upon completion of enrollment and consideration of transparent results reporting, it was decided to move all the items related to the observational supplemental study to its own record.
To improve clarity in the record, the two arms representing stage 1 of the project were incorporated into the remaining four representing stage 2, so the remaining arms now represent both stage 1 and stage 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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(US) 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)
- •Recanalized umbilical vein (by US or cross-sectional imaging)
- •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
排除标准
- •Overt hepatic encephalopathy (HE) within 6 months, requiring >28 days total of lactulose
- •Took lactulose for non - HE reasons for >28 days total in last 6 months
- •Took Rifaximin for > 28 days total 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 lower body physical and/or occupational 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
- •Inclusion Criteria for the Caregivers of the participants:
- •Adult > 18 years of age
- •Informal caregiver of a participant enrolled in LIVE-SMART
- •English speaking
- •Exclusion Criteria for the Caregivers of the participants:
- •- Non-English speaking
研究组 & 干预措施
Treatment (Lactulose) plus Enhanced Usual Care then recommended exercise
Lactulose plus Enhanced Usual Care (EUC) at Stage 1 (12 weeks) and then re-randomization to Lactulose plus EUC then Investigator-Recommended Exercise at Stage 2
干预措施: Enhanced Usual Care (Behavioral)
Treatment (Lactulose) plus Enhanced Usual Care then TeleTai-Chi exercise classes
Lactulose plus Enhanced Usual Care (EUC) at Stage 1 (12 weeks) and then re-randomization to Lactulose plus EUC then TeleTai-Chi exercise classes at Stage 2
干预措施: Enhanced Usual Care (Behavioral)
Treatment (Lactulose) plus Enhanced Usual Care then TeleTai-Chi exercise classes
Lactulose plus Enhanced Usual Care (EUC) at Stage 1 (12 weeks) and then re-randomization to Lactulose plus EUC then TeleTai-Chi exercise classes at Stage 2
干预措施: TeleTai-Chi (virtual) (Behavioral)
Enhanced Usual Care group followed by Tele-Tai Chi exercise classes
Enhanced Usual Care (EUC) at Stage 1 (12 weeks) and then re-randomization to EUC then Tele-Tai Chi exercise classes at Stage 2
干预措施: Enhanced Usual Care (Behavioral)
Enhanced Usual Care group followed by Tele-Tai Chi exercise classes
Enhanced Usual Care (EUC) at Stage 1 (12 weeks) and then re-randomization to EUC then Tele-Tai Chi exercise classes at Stage 2
干预措施: TeleTai-Chi (virtual) (Behavioral)
Treatment (Lactulose) plus Enhanced Usual Care then recommended exercise
Lactulose plus Enhanced Usual Care (EUC) at Stage 1 (12 weeks) and then re-randomization to Lactulose plus EUC then Investigator-Recommended Exercise at Stage 2
干预措施: Investigator recommended exercise (Behavioral)
Treatment (Lactulose) plus Enhanced Usual Care then recommended exercise
Lactulose plus Enhanced Usual Care (EUC) at Stage 1 (12 weeks) and then re-randomization to Lactulose plus EUC then Investigator-Recommended Exercise at Stage 2
干预措施: Lactulose (Drug)
Treatment (Lactulose) plus Enhanced Usual Care then TeleTai-Chi exercise classes
Lactulose plus Enhanced Usual Care (EUC) at Stage 1 (12 weeks) and then re-randomization to Lactulose plus EUC then TeleTai-Chi exercise classes at Stage 2
干预措施: Lactulose (Drug)
Enhanced Usual Care group followed by investigator recommended exercise
Enhanced Usual Care (EUC) at Stage 1 (12 weeks) and then re-randomization to EUC then Investigator-Recommended Exercise at Stage 2
干预措施: Enhanced Usual Care (Behavioral)
Enhanced Usual Care group followed by investigator recommended exercise
Enhanced Usual Care (EUC) at Stage 1 (12 weeks) and then re-randomization to EUC then Investigator-Recommended Exercise at Stage 2
干预措施: Investigator recommended exercise (Behavioral)
结局指标
主要结局
Number of patients experiencing a hierarchical composite of events over 24 weeks: injurious falls, non-injurious falls, incident Hepatic Encephalopathy, liver transplant, and death/transplant
时间窗: Baseline to 24 weeks (following stage 2)
Composite outcome is defined as any of the following: • Injurious Fall: Fracture, dislocation, cut, head injury, soft - tissue injury requiring medical intervention including: Hospitalization or overnight observation in the Emergency Room (ER); surgery, transfusion, stitches * Non - Injurious Fall: Inadvertently coming to rest on the floor or lower level * Include falls that result in minor injuries that are addressed with first aid (e.g., ice, bandage) * 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 * Liver transplant: Replacement of a diseased liver with the healthy liver from another person because of acute-on-chronic liver failure (using the EASL-CLIF-C definition consisting of an acute increase in the bilirubin and/or INR, acute kidney injury, overt HE, hypertension, and hypoxia).
Number of Participants Experiencing a Hierarchical Composite of Events Over 24 Weeks: Injurious Falls, Non-injurious Falls, Incident Hepatic Encephalopathy, Liver Transplant, and Death/Transplant
时间窗: Baseline to 24 weeks
Composite outcome is defined as any of the following: • Injurious Fall: Fracture, dislocation, cut, head injury, soft - tissue injury requiring medical intervention including: Hospitalization or overnight observation in the Emergency Room (ER); surgery, transfusion, stitches * Non - Injurious Fall: Inadvertently coming to rest on the floor or lower level * Include falls that result in minor injuries that are addressed with first aid (e.g., ice, bandage) * 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 * Liver transplant: Replacement of a diseased liver with the healthy liver from another person because of acute-on-chronic liver failure (using the EASL-CLIF-C definition consisting of an acute increase in the bilirubin and/or INR, acute kidney injury, overt HE, hypertension, and hypoxia).
次要结局
- Injurious Falls(Baseline to 24 weeks (following stage 2))
- Non-Injurious Falls(Baseline to 24 weeks (following stage 2))
- Incident Overt hepatic encephalopathy (HE)(Baseline to 24 weeks (following stage 2))
- Death/transplant(Baseline to 24 weeks (following stage 2))
- Incident of Liver Transplant(Baseline to 24 weeks (following stage 2))
- Days-alive and out-of-the-hospital(Baseline to 24 weeks (following stage 2))
- Cognitive Function based on the Animal Naming Test (ANT)(Baseline to 24 weeks (following stage 2))
- Visual Analog Scale (VAS)(Baseline to 24 weeks (following stage 2))
- The Patient Reported Outcome Measurement Information System (PROMIS)-29+2 v2.1(Baseline to 24 weeks (following stage 2))
- Depression based on The Patient Reported Outcome Measurement Information System (PROMIS)-29+2 v2.1(Baseline to 24 weeks (following stage 2))
- Sleep quality based on the PROMIS-29+2 v2.1(Baseline to 24 weeks (following stage 2))
- Physical frailty based on the Liver Frailty Index(Baseline to 24 weeks (following stage 2))
- Physical frailty based on the Activities of daily living (ADLs)(Baseline to 24 weeks (following stage 2))
- Intervention Fidelity(12 and 24 weeks)
- Participant adherence(12 weeks and 24 weeks)
- Participant satisfaction with the trial and interventions based on the Patient Global Impression of Change (PGIC)(12 weeks and 24 weeks)
- Short Form (SF) - 8(12 weeks and 24 weeks)
- Injurious Falls(Baseline to 24 weeks)
- Non-Injurious Falls(Baseline to 24 weeks)
- Incident Overt Hepatic Encephalopathy (HE)(Baseline to 24 weeks)
- Death/Transplant for Acute-on-Chronic Liver Failure (ACLF)(Baseline to 24 weeks)
- Incident of Liver Transplant for Non-ACLF Reason(Baseline to 24 weeks)
- Days-alive and Out-of-the-hospital(Approximately 26 Weeks)
- Change in Cognitive Function Based on the Animal Naming Test (ANT)(Baseline to 24 weeks)
- Change in Visual Analog Scale (VAS)(Baseline to 24 weeks)
- Change in The Patient Reported Outcome Measurement Information System (PROMIS)-29+2 v2.1 Profile (PROPr)(Baseline to 24 weeks)
- Change in Depression Based on The Patient Reported Outcome Measurement Information System (PROMIS)-29+2 v2.1(Baseline to 24 weeks)
- Change in Sleep Quality Based on the PROMIS-29+2 v2.1(Baseline to 24 weeks)
- Physical Frailty Based on the Liver Frailty Index(Baseline to 24 weeks)
- Change in Physical Frailty Based on the Activities of Daily Living (ADLs)(Baseline to 24 weeks)
- Intervention Fidelity(24 weeks)
- Participant Adherence(24 weeks)
- Participant Satisfaction With the Trial and Interventions Based on the Patient Global Impression of Change (PGIC)(12 weeks and 24 weeks)
- Change in Short Form (SF) - 8(24 weeks)
研究者
Elliot B. Tapper
Associate Professor of Internal Medicine
University of Michigan