このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

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

2026年8月25日 更新者：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

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

625

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • California
      • San Francisco、California、アメリカ、94143
        • University of California San Francisco
        • コンタクト：
        • 主任研究者：
          • Jessica Rubin, MD, MPH
    • Florida
      • Miami、Florida、アメリカ、33136
        • University of Miami
        • 主任研究者：
          • David Goldberg, MD
        • コンタクト：
    • Maryland
      • Baltimore、Maryland、アメリカ、21205
        • John Hopkins University
        • コンタクト：
        • 主任研究者：
          • Alexandra Strauss, MD, PhD
    • Michigan
      • Ann Arbor、Michigan、アメリカ、48109
        • University of Michigan
        • 主任研究者：
          • Elliot Tapper, MD
        • コンタクト：
    • Minnesota
      • Rochester、Minnesota、アメリカ、55905
        • Mayo Clinic
        • 主任研究者：
          • Douglas Simonetto, MD
        • コンタクト：
    • New York
      • New York、New York、アメリカ、10032
        • Columbia University
        • 主任研究者：
          • Elizabeth Verna, MD
        • コンタクト：
    • Pennsylvania
    • Tennessee
      • Nashville、Tennessee、アメリカ、37232
        • Vanderbilt University
        • コンタクト：
        • 主任研究者：
          • Ashley Spann, MD, MS

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：支持療法
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
行動：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.
実験的：Low-Touch
Participants receive access to the self-guided digital self-management platform with automated educational content and behavioral nudges for 48 weeks.
行動：Low-touch self-management program
Access to the self-guided digital self-management platform with automated educational content and behavioral nudges for 48 weeks.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Pain Interference
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Health-related quality of life
時間枠：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
時間枠：48 weeks
Change from baseline in average daily step count over 48 weeks, captured via wearable fitness trackers (Fitbit).
48 weeks
Pain-related disability
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University of Pennsylvania

協力者

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

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2027年1月1日

一次修了 (推定)

2030年3月1日

研究の完了 (推定)

2030年6月1日

試験登録日

最初に提出

2026年8月14日

QC基準を満たした最初の提出物

2026年8月25日

最初の投稿 (実際)

2026年8月28日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月28日

QC基準を満たした最後の更新が送信されました

2026年8月25日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • MP-2025C1-43619

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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 共有時間枠

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

IPD 共有アクセス基準

Results submitted to ClinicalTrials.gov or other applicable database

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する