一项随机对照试验的研究方案，以试点“恢复能量，活动有益（REACH）”：一种针对系统性红斑狼疮疲劳的移动健康支持的同伴辅导干预措施。

Study protocol for a randomized controlled trial to pilot Restore Energy, Activity Can Help (REACH): an mHealth-enabled peer coaching intervention for fatigue in systemic lupus erythematosus.

作者信息

Gulati Nina, Singh Kiran, Morrissey Erin, Calvache Priscilla, Rose-Smith Jillian, Gore-Massy Monique, Chiu Faye, Trinquart Ludovic, Navarro-Millan Iris, Folta Sara, Kasturi Shanthini

机构信息

Tufts University School of Medicine, Boston, MA, USA.

Division of Rheumatology, Department of Medicine, Tufts Medical Center, Boston, MA, USA.

出版信息

Contemp Clin Trials Commun. 2025 Jun 7;46:101508. doi: 10.1016/j.conctc.2025.101508. eCollection 2025 Aug.

DOI:10.1016/j.conctc.2025.101508

PMID:40548142

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12178804/

Abstract

BACKGROUND

Fatigue affects up to 90 % of individuals with systemic lupus erythematosus (SLE), significantly impairing quality of life. Despite its impact, fatigue remains difficult to treat due to its multifactorial nature, including behavioral, psychosocial, and pain-related contributors. While physical activity interventions show promise in reducing SLE-related fatigue, they often fail to address these broader factors and are limited by accessibility challenges. Innovative, scalable solutions are needed to improve fatigue management in SLE.

METHODS

The Restore Energy, Activity Can Help (REACH) study is an open-label randomized controlled trial to evaluate the feasibility and preliminary efficacy of the REACH peer coaching intervention delivered via mobile health (mHealth) technology compared to the REACH mHealth application (app)-only control arm. Trained peer coaches with lived SLE experience will use behavior change strategies to support participants through a 12-week structured program supported by the REACH app. Participants in the control arm will receive access to the REACH app without peer coaching. Feasibility outcomes include adherence, engagement, and acceptability, while preliminary efficacy will be assessed through fatigue reduction as measured by the Fatigue Severity Scale.

DISCUSSION

This study will pilot test the feasibility and effectiveness of the REACH peer coaching intervention, a behavioral theory-based program leveraging mHealth technology to improve fatigue management in SLE. We hypothesize that the REACH program will be feasible and address the behavioral and psychosocial drivers of SLE-related fatigue. REACH may offer a scalable, patient-centered approach that can inform implementation of mHealth-supported peer coaching programs to improve quality of life in diverse populations.

TRIAL REGISTRATION

Clinicaltrials.gov NCT06479213; Registered: June 28, 2024.

摘要

背景

疲劳影响高达90%的系统性红斑狼疮（SLE）患者，严重损害生活质量。尽管其影响重大，但由于疲劳具有多因素性质，包括行为、心理社会和疼痛相关因素，因此仍然难以治疗。虽然体育活动干预在减轻SLE相关疲劳方面显示出前景，但它们往往未能解决这些更广泛的因素，并且受到可及性挑战的限制。需要创新的、可扩展的解决方案来改善SLE患者的疲劳管理。

方法

恢复能量，活动有益（REACH）研究是一项开放标签随机对照试验，旨在评估通过移动健康（mHealth）技术提供的REACH同伴指导干预与仅使用REACH移动健康应用程序（应用程序）的对照组相比的可行性和初步疗效。具有SLE实际生活经验的经过培训的同伴指导者将使用行为改变策略，通过REACH应用程序支持的为期12周的结构化计划来支持参与者。对照组的参与者将可以使用REACH应用程序，但没有同伴指导。可行性结果包括依从性、参与度和可接受性，而初步疗效将通过疲劳严重程度量表测量的疲劳减轻情况进行评估。

讨论

本研究将对REACH同伴指导干预的可行性和有效性进行试点测试，这是一个基于行为理论的项目，利用mHealth技术改善SLE患者的疲劳管理。我们假设REACH项目将是可行的，并能解决SLE相关疲劳的行为和心理社会驱动因素。REACH可能提供一种可扩展的、以患者为中心的方法，可为实施mHealth支持的同伴指导项目提供参考，以改善不同人群的生活质量。