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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
  1. Katie L Druce1,
  2. Lis Cordingley2,
  3. Vicky Short1,
  4. Susan Moore1,
  5. Bruce Hellman3,
  6. Ben James3,
  7. Mark Lunt1,
  8. Simon D Kyle4,
  9. Will G Dixon1,5,
  10. John McBeth1,5
  1. 1 Arthritis Research UK Centre for Epidemiology, University of Manchester, Manchester, UK
  2. 2 Division of Musculoskeletal and Dermatological Sciences, Manchester University, Manchester, UK
  3. 3 uMotif, London, UK
  4. 4 Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK
  5. 5 NIHR Manchester Musculoskeletal Biomedical Research Centre, Central Manchester University Hospitals NHS Foundation Trust, Manchester, UK
  1. Correspondence to Dr Katie L Druce; katie.druce{at}manchester.ac.uk

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.

  • sleep medicine
  • rheumatology
  • epidemiology

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • 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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