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Nov 20, 2020;9 (11): e18929.

The Active Brains Digital Intervention to Reduce Cognitive Decline in Older Adults: Protocol for a Feasibility Randomized Controlled Trial.

Kirsten Ailsa Smith, Katherine Bradbury, Rosie Essery, Sebastien Pollet, Fiona Mowbray, Joanna Slodkowska-Barabasz, James Denison-Day, Victoria Hayter, Jo Kelly, Jane Somerville, Jin Zhang, Elisabeth Grey, Max Western, Anne E Ferrey, Adele Krusche, Beth Stuart, Nanette Mutrie, Sian Robinson, Guiqing Lily Yao, Gareth Griffiths, Louise Robinson, Martin Rossor, John Gallacher, Simon Griffin, Tony Kendrick, Shanaya Rathod, Bernard Gudgin, Rosemary Phillips, Tom Stokes, John Niven, Paul Little, Lucy Yardley
Author Information
  1. Kirsten Ailsa Smith: Centre for Community and Clinical Applications of Health Psychology, University of Southampton, Southampton, United Kingdom. ORCID
  2. Katherine Bradbury: Centre for Community and Clinical Applications of Health Psychology, University of Southampton, Southampton, United Kingdom. ORCID
  3. Rosie Essery: Centre for Community and Clinical Applications of Health Psychology, University of Southampton, Southampton, United Kingdom. ORCID
  4. Sebastien Pollet: Centre for Community and Clinical Applications of Health Psychology, University of Southampton, Southampton, United Kingdom. ORCID
  5. Fiona Mowbray: Centre for Community and Clinical Applications of Health Psychology, University of Southampton, Southampton, United Kingdom. ORCID
  6. Joanna Slodkowska-Barabasz: Centre for Community and Clinical Applications of Health Psychology, University of Southampton, Southampton, United Kingdom. ORCID
  7. James Denison-Day: Centre for Community and Clinical Applications of Health Psychology, University of Southampton, Southampton, United Kingdom. ORCID
  8. Victoria Hayter: Centre for Community and Clinical Applications of Health Psychology, University of Southampton, Southampton, United Kingdom. ORCID
  9. Jo Kelly: Primary Care and Population Sciences, University of Southampton, Southampton, United Kingdom. ORCID
  10. Jane Somerville: Primary Care and Population Sciences, University of Southampton, Southampton, United Kingdom. ORCID
  11. Jin Zhang: Centre for Community and Clinical Applications of Health Psychology, University of Southampton, Southampton, United Kingdom. ORCID
  12. Elisabeth Grey: Department for Health, University of Bath, Bath, United Kingdom. ORCID
  13. Max Western: Department for Health, University of Bath, Bath, United Kingdom. ORCID
  14. Anne E Ferrey: Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom. ORCID
  15. Adele Krusche: Centre for Community and Clinical Applications of Health Psychology, University of Southampton, Southampton, United Kingdom. ORCID
  16. Beth Stuart: Primary Care and Population Sciences, University of Southampton, Southampton, United Kingdom. ORCID
  17. Nanette Mutrie: Physical Activity for Health Research Centre, University of Edinburgh, Edinburgh, United Kingdom. ORCID
  18. Sian Robinson: NIHR Newcastle Biomedical Research Centre, Newcastle University and Newcastle upon Tyne NHS Foundation Trust, Newcastle upon Tyne, United Kingdom. ORCID
  19. Guiqing Lily Yao: Primary Care and Population Sciences, University of Southampton, Southampton, United Kingdom. ORCID
  20. Gareth Griffiths: Southampton Clinical Trials Unit, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom. ORCID
  21. Louise Robinson: Institute of Population Health Sciences, University of Newcastle, Newcastle upon Tyne, United Kingdom. ORCID
  22. Martin Rossor: Dementia Research Centre, University College London, London, United Kingdom. ORCID
  23. John Gallacher: Department of Psychiatry, University of Oxford, Oxford, United Kingdom. ORCID
  24. Simon Griffin: Department of Public Health and Primary Care, University of Cambridge, Cambridge, United Kingdom. ORCID
  25. Tony Kendrick: Primary Care and Population Sciences, University of Southampton, Southampton, United Kingdom. ORCID
  26. Shanaya Rathod: Southern Health NHS Foundation Trust, Southampton, United Kingdom. ORCID
  27. Bernard Gudgin: Public and Patient Involvement (PPI) representative, University of Southampton, Southampton, United Kingdom. ORCID
  28. Rosemary Phillips: Public and Patient Involvement (PPI) representative, University of Southampton, Southampton, United Kingdom. ORCID
  29. Tom Stokes: Public and Patient Involvement (PPI) representative, University of Southampton, Southampton, United Kingdom. ORCID
  30. John Niven: Public and Patient Involvement (PPI) representative, University of Southampton, Southampton, United Kingdom. ORCID
  31. Paul Little: Primary Care and Population Sciences, University of Southampton, Southampton, United Kingdom. ORCID
  32. Lucy Yardley: Centre for Community and Clinical Applications of Health Psychology, University of Southampton, Southampton, United Kingdom. ORCID
PMID: 33216010 DOI: 10.2196/18929

Abstract

BACKGROUND: Increasing physical activity, improving diet, and performing brain training exercises are associated with reduced Cognitive Decline in older adults.
OBJECTIVE: In this paper, we describe a feasibility trial of the Active Brains intervention, a web-based digital intervention developed to support older adults to make these 3 healthy behavior changes associated with improved cognitive health. The Active Brains trial is a randomized feasibility trial that will test how accessible, acceptable, and feasible the Active Brains intervention is and the effectiveness of the study procedures that we intend to use in the larger, main trial.
METHODS: In the randomized controlled trial (RCT), we use a parallel design. We will be conducting the intervention with 2 populations recruited through GP practices (family practices) in England from 2018 to 2019: older adults with signs of Cognitive Decline and older adults without any Cognitive Decline. Trial participants were randomly allocated to 1 of 3 study groups: usual care, the Active Brains intervention, or the Active Brains website plus brief support from a trained coach (over the phone or by email). The main outcomes are performance on cognitive tasks, quality of life (using EuroQol-5D 5 level), Instrumental Activities of Daily Living, and diagnoses of dementia. Secondary outcomes (including depression, enablement, and health care costs) and process measures (including qualitative interviews with participants and supporters) will also be collected. The trial has been approved by the National Health Service Research Ethics Committee (reference 17/SC/0463).
RESULTS: Results will be published in peer-reviewed journals, presented at conferences, and shared at public engagement events. Data collection was completed in May 2020, and the results will be reported in 2021.
CONCLUSIONS: The findings of this study will help us to identify and make important changes to the website, the support received, or the study procedures before we progress to our main randomized phase III trial.
TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number 23758980; http://www.isrctn.com/ISRCTN23758980.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/18929.

Keywords

dementia feasibility studies geriatrics internet-based intervention randomized controlled trial telemedicine

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Grants

  1. MC_UU_00006/6/Medical Research Council
  2. MC_UU_12015/4/Medical Research Council
  3. MR/L023784/2/Medical Research Council
Journal Article
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