The Application of Lifestyle Enhancing Validated Integrative Therapies for Everyday Pain in Cirrhosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 625
- 试验地点
- 8
- 主要终点
- Pain Interference
研究概览
简要总结
The goal of this clinical trial is to test a low-touch vs high-touch drug-free pain self-management program that may help lower pain and improve quality of life for adults with cirrhosis and pain. Participants are assigned by chance to one of two study groups. The groups receive different levels of support. The main questions it aims to answer are:
- Do the programs help lower pain?
- Do the programs improve quality of life?
- Is one program more effective than the other?
Researchers will compare a low-touch self management program to a high-touch self-management program to see if the programs help manage pain.
Participants in the low-touch arm will:
- Learn new ways to manage pain without medication
- Receive access to the self-guided digital self-management platform
- Receive general behavioral text message nudges
- Receive a free Fitbit to keep
Participants in the high-touch arm will:
- Learn new ways to manage pain without medication
- Receive tailored access to the self-guided digital self-management platform
- Received individualized pain coaching and optional group coaching sessions
- Participate in a structured walking or meditation curriculum
- Receive a free Fitbit to keep
详细描述
The Application of Lifestyle Enhancing Validated Integrative Therapies for Everyday Pain in Cirrhosis (ALLEVIATE-C) is a multicenter, individual-level, parallel-arm, 1:1 randomized superiority trial with a 4-week run-in period followed by 48 weeks of intervention and follow-up. The study will compare effectiveness of a high-touch vs low-touch self-management program to treat chronic pain among patients with cirrhosis.
Participants in the high-touch arm receive tailored digital self-management program, individualized pain coaching, and a structured walking or meditation curriculum selected through Active Choice as the primary behavioral focus for 48 weeks. The high-touch arm also includes on-demand coaching for low-pain self-efficacy and optional group coaching sessions.
Participants in the low-touch arm receive access to the self-guided digital self-management platform with automated educational content and behavioral nudges for 48 weeks.
Remote or in-person follow up study visits will occur at 12, 24, 36, and 48 weeks.
Endpoints include:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Patient Inclusion Criteria:
- •Age > 18 years of age.
- •Clinical diagnosis of cirrhosis established by any one of the following:
- •Liver biopsy consistent with cirrhosis.
- •Noninvasive evidence of cirrhosis, defined as ≥2 of the following criteria:
- •Imaging (Ultrasound (US), Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)) demonstrating cirrhosis liver morphology (e.g., 'cirrhosis', cirrhotic appearing', 'nodular') with supportive findings (e.g., splenomegaly or recanalized umbilical vein).
- •Transient elastography (TE) (FibroScan) liver stiffness > 12.5 kilopascal (kPa) with IQR/Median <30% or Magnetic resonance elastography > 5.0 kPa
- •Laboratory evidence including AST/platelet ratio index (APRI) >2.0, FIB-4 >2.67 or Platelet count <150 x 10⁹/L.
- •CT, MRI, or Esophagogastroduodenoscopy (EGD) showing the presence of esophageal varices
- •History of at least one cirrhosis complication, including variceal hemorrhage, hepatocellular carcinoma (HCC), ascites, or hepatic encephalopathy.
- •Liver transplant recipients are eligible if the transplanted cirrhotic allograft meets the above criteria.
- •Chronic pain, defined as a Pain, Enjoyment of Life, and General Activity (PEG) scale score > 4, assessed during screening prior to consent.
- •Ability to ambulate (walk), either independently or with the use of assistive devices.
- •Reliable access to Wi-Fi or cellular data.
- •Ownership of, or reliable access to, a smartphone with the ability and willingness to receive study-related text messages.
- •Ability to speak and read English or Spanish.
排除标准
- •Acute pain due to injury (e.g., surgery, fracture, trauma, burn) within 28 days.
- •Diagnosed or suspected noncirrhotic portal hypertension.
- •Episode of overt hepatic encephalopathy (HE) within 28 days prior to consent.
- •a. Overt HE is defined as acute disorientation requiring hospitalization or initiation of HE-directed therapy (e.g., lactulose, fluids, rifaximin) with diagnosis made by a gastroenterologist, hepatologist, or study investigator and resolution following therapy.
- •Model for End-Stage Liver Disease - Na (MELD-Na) score > 25 calculated using the UNOS algorithm.
- •a. Participants with MELD-Na > 25 due to clinically stable end-stage renal disease (ESRD) may be eligible if total bilirubin < 5 mg/dL.
- •Advanced hepatocellular carcinoma (HCC) defined as Barcelona Clinic Liver Cancer (BCLC) stage > C, or current treatment with systemic therapy for HCC (e.g., sorafenib, atezolizumab/bevacizumab, durvalumab/tremelimumab, regorafenib, cabozantinib).
- •> 2 paracenteses within 56 days prior to consent.
- •Fontan-associated liver disease without cirrhosis on biopsy.
- •Inpatient hospital admission lasting > 24 hours within 28 days prior to consent.
- •Active metastatic solid malignancy or acute leukemia within 3 years prior to consent.
- •Estimated life expectancy < 1 year, as determined by the study investigator.
- •Planned living donor liver transplantation within 12 weeks of enrollment.
- •Routine meditation practice, defined as meditation occurring weekly or more frequently.
- •Inability to participate in study procedures, including inability to read study materials, cognitive impairment, or psychiatric illness that would preclude participation in the opinion of the investigator.
- •Concurrent enrollment in another nonpharmacologic pain management study or formal pain management program utilizing nonpharmacologic approaches.
- •Deemed unsuitable for participation by the study investigator.
- •Care Partner Inclusion Criteria
- •Age > 18 years of age.
- •Informal caregiver of a participant enrolled in ALLEVIATE-C
- •Ability to speak and read English or Spanish.
- •Care Partner Exclusion Criteria
- •Inability to participate in study procedures, including inability to read study materials, cognitive impairment, or psychiatric illness that would preclude participation in the opinion of the investigator.
- •Deemed unsuitable for participation by the study investigator.
研究组 & 干预措施
High-Touch
Participants receive tailored digital self-management program, individualized pain coaching, and a structured walking or meditation curriculum selected through Active Choice as the primary behavioral focus for 48 weeks. The high-touch arm also includes on-demand coaching for low-pain self-efficacy and optional group coaching sessions.
干预措施: High-touch self-management program (Behavioral)
Low-Touch
Participants receive access to the self-guided digital self-management platform with automated educational content and behavioral nudges for 48 weeks.
干预措施: Low-touch self-management program (Behavioral)
结局指标
主要结局
Pain Interference
时间窗: 48 weeks
Change from baseline in pain interference over 48 weeks, measured by repeated assessments using the Pain, Enjoyment of life, and General activity (P.E.G.) scale at 12, 24, 36, and 48 weeks, and compared between the two groups. The PEG is a three-item scale with a minimum value of 0 and a maximum value of 10 for each question. A higher score indicates a worse outcome.
次要结局
- Health-related quality of life(48 weeks)
- Average daily step count(48 weeks)
- Pain-related disability(48 weeks)
- Severity of nociplastic pain(52 weeks)
- Cumulative exposure to potentially risky medications(48 weeks)
- Days alive and out of the hospital(48 weeks)
- Animal Naming Test(48 weeks)
- Patient-reported use and perceived effectiveness of pharmacologic and non-pharmacologic pain management strategies(52 weeks)
- Caregiver burden(48 weeks)