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Protocol
Protocol for the process evaluation of the Promoting Activity, Independence and Stability in Early Dementia (PrAISED), following changes required by the COVID-19 pandemic
  1. Claudio Di Lorito1,
  2. Alessandro Bosco2,
  3. Sarah E Goldberg3,
  4. Roshan Nair2,
  5. Rebecca O'Brien1,
  6. Louise Howe1,
  7. Veronika van der Wardt4,
  8. Kristian Pollock3,
  9. Vicky Booth1,
  10. Pip Logan1,
  11. Maureen Godfrey1,
  12. Marianne Dunlop1,
  13. Jane Horne1,
  14. Rowan H Harwood3
  1. 1Division of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, UK
  2. 2Division of Psychiatry and Applied Psychology, University of Nottingham, Nottingham, UK
  3. 3School of Health Sciences, University of Nottingham, Nottingham, UK
  4. 4Philipps-Universitat Marburg, Marburg, Hessen, Germany
  1. Correspondence to Dr Claudio Di Lorito; claudio.dilorito{at}nottingham.ac.uk

Abstract

Introduction The Promoting Activity, Independence and Stability in Early Dementia (PrAISED) randomised controlled trial (RCT) is evaluating a home-based, face-to-face, individually tailored, activity and exercise programme for people living with dementia. Social distancing requirements following the COVID-19 pandemic necessitated rapid changes to intervention delivery.

Methods and analysis A mixed-methods process evaluation will investigate how the changes were implemented and the impact that these have on participants’ experience. An implementation study will investigate how the intervention was delivered during the pandemic. A study on the mechanisms of impact and context will investigate how these changes were experienced by the PrAISED participants, their carers and the therapists delivering the intervention. The study will commence in May 2020.

Ethics and dissemination The PrAISED RCT and process evaluation have received ethical approval number 18/YH/0059. The PrAISED process evaluation will enable us to understand how distancing and isolation affected participants, their activity and exercise routines and whether the therapy programme could be continued with remote support. This will be valuable both in explaining trial results and also contribute to understanding and designing new ways of delivering home-based services and rehabilitation interventions for people with dementia and their carers.

Trial registration number ISRCTN15320670; Pre-results.

  • geriatric medicine
  • dementia
  • rehabilitation medicine
  • sports medicine
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Footnotes

  • Contributors CDL contributed to the conception and design of the study, and the development of all the elements of the process evaluation. AB contributed to the planning of the process evaluation, the analysis plan for therapists’ audio recordings and provided feedback and final approval of the manuscript. SEG contributed the PrAISED RCT information, helped in the conception of the study and provided feedback and final approval of the manuscript. RN contributed to the development of the analysis plan for the qualitative element of the study and the therapists’ audio recordings and provided feedback and final approval of the manuscript. ROB contributed to develop the study design and the analysis plan of the therapists’ audio recordings and provided feedback and final approval of the manuscript. LH helped to develop the topic guide for the therapists’ qualitative interviews, as well as the analysis plan and provided feedback and final approval of the manuscript. VvdW contributed to the study conception and design, the implementation study, the quantitative data analysis plan and provided feedback and final approval of the manuscript. KP provided guidance and expertise on the development of the qualitative interviews for participants with dementia and carers and provided feedback and final approval of the manuscript. VB contributed to the design and analysis plan of the implementation study and provided feedback and final approval of the manuscript. PL contributed to the discussion section of the manuscript and provided feedback and final approval of the manuscript. MG and MD were the PPI collaborators of the study. They contributed to the development of the topic guide for the qualitative interviews of the participants with dementia and their carers and provided feedback and final approval of the manuscript. JH contributed to the discussion section of the manuscript and provided feedback and final approval of the manuscript. RHH contributed the PrAISED RCT information, helped in the conception of the study and provided feedback and final approval of the manuscript.

  • Funding This protocol presents independent research funded by the United Kingdom National Institute for Health Research (NIHR) under its Programme Grants for Applied Research funding scheme (RP-PG-0614-20007). The views expressed are those of the authors and not necessarily those of the National Health Service, the NIHR or the Department of Health and Social Care.

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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