Improving multimodal physical function in adults with heterogeneous chronic pain; Protocol for a multisite feasibility RCT.

Autor: Hooker JE; Center for Health Outcomes and Interdisciplinary Research, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States; Harvard Medical School, Boston, MA, United States., Brewer JR; Center for Health Outcomes and Interdisciplinary Research, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States., McDermott KA; Center for Health Outcomes and Interdisciplinary Research, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States; Harvard Medical School, Boston, MA, United States., Kanaya M; Center for Health Outcomes and Interdisciplinary Research, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States., Somers TJ; Duke University School of Medicine, Department of Psychiatry and Behavioral Sciences, Durham, NC, United States., Keefe F; Duke University School of Medicine, Department of Psychiatry and Behavioral Sciences, Durham, NC, United States., Kelleher S; Duke University School of Medicine, Department of Psychiatry and Behavioral Sciences, Durham, NC, United States., Fisher HM; Duke University School of Medicine, Department of Psychiatry and Behavioral Sciences, Durham, NC, United States., Burns J; Rush University, Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, IL, United States., Jeddi RW; Rush University, Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, IL, United States; Rush University, Department of Family and Preventive Medicine, Rush University Medical Center, Chicago, IL, United States., Kulich R; Harvard Medical School, Boston, MA, United States; Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Boston, MA, United States., Polykoff G; Harvard Medical School, Boston, MA, United States; Department of Physical Medicine and Rehabilitation, Massachusetts General Hospital, Boston, MA, United States., Parker RA; Biostatistics Center, Massachusetts General Hospital, Boston, MA, United States., Greenberg J; Center for Health Outcomes and Interdisciplinary Research, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States; Harvard Medical School, Boston, MA, United States., Vranceanu AM; Center for Health Outcomes and Interdisciplinary Research, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States; Harvard Medical School, Boston, MA, United States.
Jazyk: angličtina
Zdroj: Contemporary clinical trials [Contemp Clin Trials] 2024 Mar; Vol. 138, pp. 107462. Date of Electronic Publication: 2024 Jan 28.
DOI: 10.1016/j.cct.2024.107462
Abstrakt: Background: Chronic pain is associated with substantial impairment in physical function, which has been identified as a top concern among persons with pain. GetActive-Fitbit, a mind-body activity program, is feasible, acceptable, and associated with improvement in physical function among primarily White, sedentary individuals with pain. In preparation for a multisite efficacy trial, we must examine feasibility across multiple sites with diverse patient populations. Here we describe the protocol of a multisite, feasibility RCT comparing GetActive-Fitbit with a time- and attention-matched educational comparison (Healthy Living for Pain). We aim to 1) test multisite fidelity of clinician training; 2) evaluate multisite feasibility benchmarks, including recruitment of chronic pain patients taking <5000 steps/day and racial and ethnic minorities; and 3) optimize fidelity and study protocol in preparation for a future multisite efficacy trial.
Methods: Clinician training fidelity was assessed via roleplays and mock group sessions. Feasibility (i.e., recruitment, acceptability, credibility, adherence, satisfaction), multimodal physical function (e.g., self-report, 6-Minute Walk Test, step-count), and other psychosocial outcomes are assessed at baseline, posttest, and 6 months. Protocol optimization will be assessed using exit interviews and cross-site meetings.
Results: The trial is ongoing. Clinician training is complete. 87 participants have been recruited. 54 completed baseline assessments and randomization, 44 are mid-intervention, and 9 have completed the intervention and posttest.
Conclusions: This study addresses the critical need for feasible, acceptable mind-body-activity interventions for chronic pain that follow evidence-based guidelines and improve all aspects of physical function across diverse populations. Results will inform a future fully-powered multisite efficacy trial.
Clinical Trial Registration: NCT05700383.
Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2024 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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