Study protocol for a randomized controlled trial to pilot Restore Energy, Activity Can Help (REACH): an...

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.

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.

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.

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