Quality of life, sleep and rheumatoid arthritis (QUASAR): a protocol for a prospective UK mHealth study to investigate the relationship between sleep and quality of life in adults with rheumatoid arthritis

Abstract

Introduction: People with rheumatoid arthritis (RA) frequently report reduced health-related quality of life (HRQoL), the impact one's health has on physical, emotional and social well-being. There are likely numerous causes for poor HRQoL, but people with RA have identified sleep disturbances as a key contributor to their well-being. This study will identify sleep/wake rhythm-associated parameters that predict HRQoL in patients with RA.

Methods and analysis: This prospective cohort study will recruit 350 people with RA, aged 18 years or older. Following completion of a paper-based baseline questionnaire, participants will record data on 10 symptoms including pain, fatigue and mood two times a day for 30 days using a study-specific mobile application (app). A triaxial accelerometer will continuously record daytime activity and estimate evening sleep parameters over the 30 days. Every 10 days following study initiation, participants will complete a questionnaire that measures disease specific (Arthritis Impact Measurement Scale 2-Short Form (AIMS2-SF)) and generic (WHOQOL-BREF) quality of life. A final questionnaire will be completed at 60 days after entering the study. The primary outcomes are the AIMS2-SF and WHOQOL-BREF. Structural equation modelling and latent trajectory models will be used to examine the relationship between sleep/wake rhythm-associated parameters and HRQoL, over time.

Ethics and dissemination: Results from this study will be disseminated at regional and international conferences, in peer-reviewed journals and Patient and Public Engagement events, as appropriate.

Keywords: epidemiology; rheumatology; sleep medicine.

Figure 1

Flow of participant entry into the study. QUASAR, quality of life, sleep and rheumatoid arthritis.

Figure 2

Screenshot of uMotif study app.

Figure 3

Screenshot of consensus sleep diary within study app.

Figure 4

Data collection and participant contact across 60 days for participants enrolled in QUASAR. AIMS2-SF, Arthritis Impact Measurement Scale 2-Short Form; ASES-8, Arthritis Self-Efficacy Scale-8 item; CAQ-8, Committed Action Questionnaire; DBAS-16, Dysfunctional Beliefs and Attitudes about Sleep questionnaire; HADS, Hospital Anxiety and Depression Scale; PSQI, Pittsburgh Sleep Quality Index; QoL, Quality of Life; QUASAR, quality of life, sleep and rheumatoid arthritis; RA, rheumatoid arthritis; RAPID-3, Routine Assessment of Patient Index Data 3; SCI, Sleep Condition Indicator.

Figure 5

Hypothetical model of the pathways of relationship between rheumatoid arthritis and quality of life disease severity, sleep, fatigue, mood and pain—simple model. In this figure, rectangles represent observed variables and circles represent the constructs those variables represent. Solid arrows represent the pathways to be tested. AIMS2-SF, Arthritis Impact Measurement Scale 2-Short Form; CSD, Consensus Sleep Diary; PSQI, Pittsburgh Sleep Quality Index; RAPID-3, Routine Assessment of Patient Index Data 3.