一项随机对照试验的研究方案，以试点恢复能量，活动可以帮助（REACH）：一个移动健康支持同伴指导干预系统性红斑狼疮疲劳

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2025-06-07 DOI:10.1016/j.conctc.2025.101508

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

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引用次数: 0

摘要

背景：高达90%的系统性红斑狼疮（SLE）患者会出现疲劳，严重影响生活质量。尽管疲劳有其影响，但由于其多因素的性质，包括行为、社会心理和疼痛相关的因素，疲劳仍然难以治疗。虽然身体活动干预措施有望减少与外语相关的疲劳，但它们往往无法解决这些更广泛的因素，并受到无障碍挑战的限制。需要创新的、可扩展的解决方案来改善SLE的疲劳管理。方法恢复能量，活动可以帮助（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同伴指导干预的可行性和初步效果，并与仅使用REACH移动健康应用程序（app）的对照组进行比较。经过培训、有SLE生活经验的同伴教练将使用行为改变策略，通过一个由REACH应用程序支持的为期12周的结构化项目来支持参与者。对照组的参与者将在没有同伴指导的情况下使用REACH应用程序。可行性结果包括依从性、参与度和可接受性，而初步效果将通过疲劳严重程度量表测量的疲劳减少来评估。本研究将试点测试REACH同伴指导干预的可行性和有效性，这是一个基于行为理论的项目，利用移动健康技术改善SLE的疲劳管理。我们假设REACH计划将是可行的，并解决与睡眠障碍相关的疲劳的行为和社会心理驱动因素。REACH可以提供一种可扩展的、以患者为中心的方法，可以为移动健康支持的同伴指导计划的实施提供信息，以提高不同人群的生活质量。临床试验注册：clinicaltrials .gov NCT06479213；注册日期：2024年6月28日。

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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

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.

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.