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The Application of Lifestyle Enhancing Validated Integrative Therapies for Everyday Pain in Cirrhosis (ALLEVIATE-C)

25. srpna 2026 aktualizováno: University of Pennsylvania

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

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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:

  • Primary: Change from baseline in pain interference over 48 weeks (measured using the Pain, Enjoyment of Life, and General Activity (PEG) scale).
  • Secondary: Health-related quality of life, cognitive function, average daily step count, pain-related disability, nociplastic pain, cumulative exposure to potentially risky medications, days alive and out of the hospital, pain management strategies, intervention engagement, and care partner burden.
  • Implementation: Acceptability, feasibility, intervention fidelity, and barriers and facilitators to implementation.

Typ studie

Intervenční

Zápis (Odhadovaný)

625

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • California
      • San Francisco, California, Spojené státy, 94143
        • University of California San Francisco
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Jessica Rubin, MD, MPH
    • Florida
      • Miami, Florida, Spojené státy, 33136
        • University of Miami
        • Vrchní vyšetřovatel:
          • David Goldberg, MD
        • Kontakt:
    • Maryland
      • Baltimore, Maryland, Spojené státy, 21205
        • John Hopkins University
        • Kontakt:
          • Lisa Datta
          • Telefonní číslo: (443) 831-1940
          • E-mail: ldatta1@jh.edu
        • Vrchní vyšetřovatel:
          • Alexandra Strauss, MD, PhD
    • Michigan
      • Ann Arbor, Michigan, Spojené státy, 48109
        • University of Michigan
        • Vrchní vyšetřovatel:
          • Elliot Tapper, MD
        • Kontakt:
    • Minnesota
      • Rochester, Minnesota, Spojené státy, 55905
        • Mayo Clinic
        • Vrchní vyšetřovatel:
          • Douglas Simonetto, MD
        • Kontakt:
    • New York
      • New York, New York, Spojené státy, 10032
        • Columbia University
        • Vrchní vyšetřovatel:
          • Elizabeth Verna, MD
        • Kontakt:
    • Pennsylvania
    • Tennessee
      • Nashville, Tennessee, Spojené státy, 37232
        • Vanderbilt University
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Ashley Spann, MD, MS

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Patient Inclusion Criteria:

  1. Age > 18 years of age.

  2. Clinical diagnosis of cirrhosis established by any one of the following:

    1. Liver biopsy consistent with cirrhosis.

    2. 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
    3. History of at least one cirrhosis complication, including variceal hemorrhage, hepatocellular carcinoma (HCC), ascites, or hepatic encephalopathy.
  3. Liver transplant recipients are eligible if the transplanted cirrhotic allograft meets the above criteria.
  4. Chronic pain, defined as a Pain, Enjoyment of Life, and General Activity (PEG) scale score > 4, assessed during screening prior to consent.
  5. Ability to ambulate (walk), either independently or with the use of assistive devices.
  6. Reliable access to Wi-Fi or cellular data.
  7. Ownership of, or reliable access to, a smartphone with the ability and willingness to receive study-related text messages.
  8. Ability to speak and read English or Spanish.

Patient Exclusion Criteria:

  1. Acute pain due to injury (e.g., surgery, fracture, trauma, burn) within 28 days.
  2. Diagnosed or suspected noncirrhotic portal hypertension.

  3. 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.

  4. 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.

  5. 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).
  6. > 2 paracenteses within 56 days prior to consent.
  7. Fontan-associated liver disease without cirrhosis on biopsy.
  8. Inpatient hospital admission lasting > 24 hours within 28 days prior to consent.
  9. Active metastatic solid malignancy or acute leukemia within 3 years prior to consent.
  10. Estimated life expectancy < 1 year, as determined by the study investigator.
  11. Planned living donor liver transplantation within 12 weeks of enrollment.
  12. Routine meditation practice, defined as meditation occurring weekly or more frequently.
  13. 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.
  14. Concurrent enrollment in another nonpharmacologic pain management study or formal pain management program utilizing nonpharmacologic approaches.
  15. Deemed unsuitable for participation by the study investigator.
  16. Prisoners.

Care Partner Inclusion Criteria

  1. Age > 18 years of age.
  2. Informal caregiver of a participant enrolled in ALLEVIATE-C
  3. Ability to speak and read English or Spanish.

Care Partner Exclusion Criteria

  1. 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.
  2. Deemed unsuitable for participation by the study investigator.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Podpůrná péče
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Behaviorální: High-touch self-management program
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. On-demand coaching for low-pain self-efficacy and optional group coaching sessions.
Experimentální: Low-Touch
Participants receive access to the self-guided digital self-management platform with automated educational content and behavioral nudges for 48 weeks.
Behaviorální: Low-touch self-management program
Access to the self-guided digital self-management platform with automated educational content and behavioral nudges for 48 weeks.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Pain Interference
Časové okno: 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.
48 weeks

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Health-related quality of life
Časové okno: 48 weeks

Change from baseline in health-related quality of life over 48 weeks, assessed using the PROMIS-29+2 Profile v2.1 (PROPr) domain T-scores (physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain interference) as well as the multidomain PROPr summary score.

Most domains of the PROPr are ranked on a scale with a minimum of 1 and a maximum of 5. Scores for domains are assessed differently. For fatigue, anxiety, depression, sleep disturbance, and pain interference, a higher score indicates a worse outcome. For physical function, cognitive function, and ability to participate in social roles, a higher score indicates a better outcome. Pain intensity is separately ranked on a scale of 0 to 10, with a higher score indicating a worse outcome.
48 weeks
Average daily step count
Časové okno: 48 weeks
Change from baseline in average daily step count over 48 weeks, captured via wearable fitness trackers (Fitbit).
48 weeks
Pain-related disability
Časové okno: 48 weeks
Change from baseline in pain-related disability at 48 weeks, measured by the Pain Disability Index (PDI) total score. The PDI is a 7-item scale with a minimum value of 0 and a maximum value of 10 for each question. A higher score indicates a worse outcome.
48 weeks
Severity of nociplastic pain
Časové okno: 52 weeks
Change from baseline in severity of nociplastic pain over 52 weeks, assessed using the Fibromyalgia Severity Score (FSS).
52 weeks
Cumulative exposure to potentially risky medications
Časové okno: 48 weeks
Change from baseline in cumulative exposure to potentially risky medications over 48 weeks, quantified using the Opioid Total Standardized Dose (TSD) across medication classes relevant to cirrhosis.
48 weeks
Days alive and out of the hospital
Časové okno: 48 weeks
Days alive and out of the hospital (DAOH) over 48 weeks, incorporating hospitalizations, emergency room (ER) visits, and death.
48 weeks
Animal Naming Test
Časové okno: 48 weeks
Change in cognitive function, measured by the Animal Naming Test (ANT), over 48 weeks.
48 weeks
Patient-reported use and perceived effectiveness of pharmacologic and non-pharmacologic pain management strategies
Časové okno: 52 weeks
Change from baseline in patient-reported use and perceived effectiveness of pharmacologic and non-pharmacologic pain management strategies at 52 weeks, assessed using a structured study-specific pain management inventory.
52 weeks
Caregiver burden
Časové okno: 48 weeks
Change from baseline in care partner caregiver burden, measured by the 12-item Zarit Burden Interview (ZBI-12), over 48 weeks.
48 weeks

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Pennsylvania

Spolupracovníci

Patient-Centered Outcomes Research Institute
Johns Hopkins University
Mayo Clinic
University of Miami
Columbia University
University of Michigan
University of California, San Francisco
Vanderbilt University Medical Center

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. ledna 2027

Primární dokončení (Odhadovaný)

1. března 2030

Dokončení studie (Odhadovaný)

1. června 2030

Termíny zápisu do studia

První předloženo

14. srpna 2026

První předloženo, které splnilo kritéria kontroly kvality

25. srpna 2026

První zveřejněno (Aktuální)

28. srpna 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

28. srpna 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

25. srpna 2026

Naposledy ověřeno

1. srpna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • MP-2025C1-43619

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

Dissemination of results from this trial will be conducted in accordance with policies and procedures established by the Executive Committee. All abstracts, presentations, and manuscripts arising from this study will be reported to the Patient-Centered Outcomes Research Institute (PCOR)I in compliance with contractual requirements.

Fundamentally, PCORI's Policy for Data Management and Data Sharing articulates PCORI's expectation that Awardees make data and data documentation (Full Data Package) from their PCORI-funded research projects available to third-party requestors.

The deposition is centered around the Full Data Package, which is comprised of the Analyzable Data Set, Full Protocol, metadata, data dictionary, full statistical analysis plan (including all amendments and all documentation for additional work processes), and analytic code from a PCORI-funded research project.

Časový rámec sdílení IPD

Results submitted to ClinicalTrials.gov or other applicable database: 9/1/2030 Contract term date: 3/31/2032

Kritéria přístupu pro sdílení IPD

Results submitted to ClinicalTrials.gov or other applicable database

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • ICF
  • ANALYTIC_CODE
  • CSR

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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