The Application of Lifestyle Enhancing Validated Integrative Therapies for Everyday Pain in Cirrhosis (ALLEVIATE-C)
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
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Undersøgelsestype
Tilmelding (Anslået)
Tilmelding
Fase
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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California
-
San Francisco, California, Forenede Stater, 94143
- University of California San Francisco
-
Kontakt:
- Rayshawnda Davis, MS
- E-mail: rayshawnda.davis@ucsf.edu
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Ledende efterforsker:
- Jessica Rubin, MD, MPH
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Florida
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Miami, Florida, Forenede Stater, 33136
- University of Miami
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Ledende efterforsker:
- David Goldberg, MD
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Kontakt:
- Cindy Delgado
- Telefonnummer: 305-243-5799
- E-mail: cdelgado5@med.miami.edu
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Maryland
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Baltimore, Maryland, Forenede Stater, 21205
- John Hopkins University
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Kontakt:
- Lisa Datta
- Telefonnummer: (443) 831-1940
- E-mail: ldatta1@jh.edu
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Ledende efterforsker:
- Alexandra Strauss, MD, PhD
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109
- University of Michigan
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Ledende efterforsker:
- Elliot Tapper, MD
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Kontakt:
- Samantha Nikirk, MPH
- Telefonnummer: 7342324182
- E-mail: samjwalk@med.umich.edu
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Minnesota
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic
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Ledende efterforsker:
- Douglas Simonetto, MD
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Kontakt:
- Amy Olofson, RN
- Telefonnummer: (507) 538-6547
- E-mail: olofson.amy@mayo.edu
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New York
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New York, New York, Forenede Stater, 10032
- Columbia University
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Ledende efterforsker:
- Elizabeth Verna, MD
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Kontakt:
- Geena Heitmann, MPH
- Telefonnummer: (212) 305-3839
- E-mail: gg2827@cumc.columbia.edu
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- University of Pennsylvania
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Kontakt:
- Richard Mason, PharmD
- Telefonnummer: 215-349-8986
- E-mail: Richard.Mason@pennmedicine.upenn.edu
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Kontakt:
- Jacqueline Theroux, MPH
- Telefonnummer: 2156623904
- E-mail: Jacqueline.Theroux@pennmedicine.upenn.edu
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Ledende efterforsker:
- Marina Serper, MD, MS
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37232
- Vanderbilt University
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Kontakt:
- Ashley Spann, MD, MS
- Telefonnummer: (615) 421-6137
- E-mail: ashley.spann@vumc.org
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Ledende efterforsker:
- Ashley Spann, MD, MS
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Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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.
Patient Exclusion Criteria:
- 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.
- Prisoners.
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
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.
|
|
Eksperimentel: Low-Touch
Participants receive access to the self-guided digital self-management platform with automated educational content and behavioral nudges for 48 weeks.
|
Access to the self-guided digital self-management platform with automated educational content and behavioral nudges for 48 weeks.
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain Interference
Tidsramme: 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
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Health-related quality of life
Tidsramme: 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
Tidsramme: 48 weeks
|
Change from baseline in average daily step count over 48 weeks, captured via wearable fitness trackers (Fitbit).
|
48 weeks
|
|
Pain-related disability
Tidsramme: 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
|
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Severity of nociplastic pain
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
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Caregiver burden
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Samarbejdspartnere
Samarbejdspartnere
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Studiestart
Primær færdiggørelse (Anslået)
Primær færdiggørelse
Studieafslutning (Anslået)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- MP-2025C1-43619
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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.
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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