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. 2025 Jun 7:46:101508.
doi: 10.1016/j.conctc.2025.101508. eCollection 2025 Aug.

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

Nina Gulati  1 , Kiran Singh  2 , Erin Morrissey  1   2 , Priscilla Calvache  3 , Jillian Rose-Smith  3 , Monique Gore-Massy  4 , Faye Chiu  5 , Ludovic Trinquart  6 , Iris Navarro-Millan  7 , Sara Folta  8 , Shanthini Kasturi  2
Affiliations

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

Nina Gulati et al. Contemp Clin Trials Commun. .

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.

Keywords: Behavioral interventions; Fatigue; Mobile health (mHealth) technology; Peer coaching; Systemic lupus erythematosus.

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Conflict of interest statement

The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Shanthini Kasturi has participated in advisory boards sponsored by GSK. Monique Gore-Massy has relationships with GSK, Bristol Myers Squibb, Aurinia, and Johnson & Johnson.

Figures

Fig. 1
Fig. 1
Theoretical framework for the intervention: Self-determination and social cognitive theories.
Fig. 2
Fig. 2
Consort diagram.
See this image and copyright information in PMC

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References

    1. Tench C.M., Mccurdie I., White P.D., Cruz D.P.D. The prevalence and associations of fatigue in systemic lupus erythematosus. Rheumatology. 2000;39:1249–1254. - PubMed
    1. Baker K., Pope J. Employment and work disability in systemic lupus erythematosus: a systematic review. Rheumatology. 2009;48(3):281–284. - PubMed
    1. Booth S., Walker E., Price E. Fluctuation, invisibility, fatigue the barriers to maintaining employment in SLE: results of an on-line survey. Lupus (Basingstoke) 2018;27:2284–2291. - PMC - PubMed
    1. Agarwal N., Kumar V. Burden of lupus on work: issues in the employment of individuals with lupus. Work (Reading, MA) 2016;55(2):429–439. - PubMed
    1. Garris C., Oglesby A., Sulcs E., Lee M. Impact of systemic lupus erythematosus on burden of illness and work productivity in the United States. Lupus (Basingstoke) 2013;22(10):1077–1086. - PubMed

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