title: Developing a service user informed intervention to improve participation and ability to perform daily activities in primary Sjögren's syndrome: a mixed-methods study protocol.
abstract: BACKGROUND
  A significant proportion of patients with primary Sjögren's syndrome (PSS) is functionally impaired and experience difficulties participating in various aspects of everyday life. There is currently no evidence of efficacy for non-pharmacological interventions aimed specifically at supporting the patients with PSS to improve their participation and ability to perform daily activities. This paper describes a research protocol for a mixed-methods study to develop an intervention to improve these outcomes. The protocol follows the Medical Research Council framework for complex interventions.
  
  
  METHODS
  We will use group concept mapping with the patients, adults who live with them and healthcare professionals to identify factors which prevent people with PSS from participating in daily life and performing daily activities. The factors will be prioritised by participants for importance and feasibility and will inform an intervention to be delivered within a National Health Service (NHS) setting. Evidence-based intervention techniques will be identified for the prioritised factors and combined into a deliverable intervention package. Key stakeholders will comment on the intervention content and mode of delivery through focus groups, and the data will be used to refine the intervention. The acceptability and feasibility of the refined intervention will be evaluated in a future study.
  
  
  BACKGROUND
  The study has been approved by an NHS Research Ethics Committee, REC Reference: 13/NI/0190. The findings of this study will be disseminated in peer-reviewed journals and through presentation at national and international conferences.
  
  
  BACKGROUND
  UKCRN Study ID: 15939.
authors.affiliation: Musculoskeletal Research Group, Institute of Cellular Medicine & NIHR Biomedical Research Centre for Ageing and Chronic Diseases, Newcastle upon Tyne, UK Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
authors.forename: Katie L
authors.initials: KL
authors.lastname: Hackett
authors.affiliation: Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK Institute of Ageing and Health, Newcastle University, UK.
authors.forename: Julia L
authors.initials: JL
authors.lastname: Newton
authors.affiliation: School of Health Sciences, University of East Anglia, Norwich, UK.
authors.forename: Katherine H O
authors.initials: KH
authors.lastname: Deane
authors.affiliation: Institute of Health and Society, Newcastle University, UK.
authors.forename: Tim
authors.initials: T
authors.lastname: Rapley
authors.affiliation: Department of Psychology, Northumbria University, UK.
authors.forename: Vincent
authors.initials: V
authors.lastname: Deary
authors.affiliation: Institute of Health and Society, Newcastle University, UK.
authors.forename: Niina
authors.initials: N
authors.lastname: Kolehmainen
authors.affiliation: Musculoskeletal Research Group, Institute of Cellular Medicine & NIHR Biomedical Research Centre for Ageing and Chronic Diseases, Newcastle upon Tyne, UK Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK NIHR Newcastle Biomedical Research Centre, Newcastle upon Tyne, UK.
authors.forename: Dennis
authors.initials: D
authors.lastname: Lendrem
authors.affiliation: Musculoskeletal Research Group, Institute of Cellular Medicine & NIHR Biomedical Research Centre for Ageing and Chronic Diseases, Newcastle upon Tyne, UK Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
authors.forename: Wan-Fai
authors.initials: WF
authors.lastname: Ng
mesh_terms: D000203:Activities of Daily Living; D003362:Cost-Benefit Analysis; D006282:Health Personnel; D006801:Humans; D011788:Quality of Life; D012107:Research Design; D012859:Sjogren's Syndrome / Q000628:therapy*
keywords: Activities of Daily Living; Concept mapping; Intervention development; Rehabilitation; Sjogren's syndrome