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.
- sleep medicine
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Contributors JM led the conception and design of the study. All authors made substantial contributions to the conception and design of the study. JM and ML planned the statistical analysis. KLD wrote the first draft of the protocol manuscript. LC, VS, SM, BH, BJ, ML, SDK, WGD and JM critically reviewed the protocol manuscript. All authors approved the final version of the document.
Funding This study is supported by Arthritis Research UK grant number 21188. The study is also supported by infrastructure support from the Arthritis Research UK Centre for Epidemiology (grant reference 20380).
Competing interests None declared.
Patient consent Not required.
Ethics approval National Research Ethics Service (NRES) Committee North West—Liverpool Central REC (reference 17/NW/0217).
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement We intend to make data available for data sharing after the data collection has been completed and the primary aims of the study are met.
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