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

      , MA, MSc, PhD 1 , , , PhD 1 , , PhD 1 , , PhD 1 , , PhD 1 , , PhD 1 , , PhD 1 , , PGDip 1 , , BSc 2 , 2 , , PhD 1 , , PhD 3 , , PhD 3 , , PhD 4 , 5 , , PhD 1 , , PhD 2 , , PhD 6 , , PhD 7 , , PhD 2 , , PhD 8 , , PhD 9 , , MD 10 , 11 , , MD 12 , , MD 2 , , MBBS 13 , , PhD 14 , 14 , 14 , 14 , , MD 2 , , PhD 1 , 15
      (Reviewer), (Reviewer), (Reviewer)
      JMIR Research Protocols
      JMIR Publications
      telemedicine, dementia, internet-based intervention, geriatrics, feasibility studies, randomized controlled trial

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          Increasing physical activity, improving diet, and performing brain training exercises are associated with reduced cognitive decline in older adults.


          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.


          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 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.


          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)


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          Most cited references79

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          Perceived Usefulness, Perceived Ease of Use, and User Acceptance of Information Technology

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            Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide

            Without a complete published description of interventions, clinicians and patients cannot reliably implement interventions that are shown to be useful, and other researchers cannot replicate or build on research findings. The quality of description of interventions in publications, however, is remarkably poor. To improve the completeness of reporting, and ultimately the replicability, of interventions, an international group of experts and stakeholders developed the Template for Intervention Description and Replication (TIDieR) checklist and guide. The process involved a literature review for relevant checklists and research, a Delphi survey of an international panel of experts to guide item selection, and a face to face panel meeting. The resultant 12 item TIDieR checklist (brief name, why, what (materials), what (procedure), who provided, how, where, when and how much, tailoring, modifications, how well (planned), how well (actual)) is an extension of the CONSORT 2010 statement (item 5) and the SPIRIT 2013 statement (item 11). While the emphasis of the checklist is on trials, the guidance is intended to apply across all evaluative study designs. This paper presents the TIDieR checklist and guide, with an explanation and elaboration for each item, and examples of good reporting. The TIDieR checklist and guide should improve the reporting of interventions and make it easier for authors to structure accounts of their interventions, reviewers and editors to assess the descriptions, and readers to use the information.
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              The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection.

              A 36-item short-form (SF-36) was constructed to survey health status in the Medical Outcomes Study. The SF-36 was designed for use in clinical practice and research, health policy evaluations, and general population surveys. The SF-36 includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. The survey was constructed for self-administration by persons 14 years of age and older, and for administration by a trained interviewer in person or by telephone. The history of the development of the SF-36, the origin of specific items, and the logic underlying their selection are summarized. The content and features of the SF-36 are compared with the 20-item Medical Outcomes Study short-form.

                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                November 2020
                20 November 2020
                : 9
                : 11
                : e18929
                [1 ] Centre for Community and Clinical Applications of Health Psychology University of Southampton Southampton United Kingdom
                [2 ] Primary Care and Population Sciences University of Southampton Southampton United Kingdom
                [3 ] Department for Health University of Bath Bath United Kingdom
                [4 ] Nuffield Department of Primary Care Health Sciences University of Oxford Oxford United Kingdom
                [5 ] NIHR Oxford Biomedical Research Centre Oxford University Hospitals NHS Foundation Trust Oxford United Kingdom
                [6 ] Physical Activity for Health Research Centre University of Edinburgh Edinburgh United Kingdom
                [7 ] NIHR Newcastle Biomedical Research Centre Newcastle University and Newcastle upon Tyne NHS Foundation Trust Newcastle upon Tyne United Kingdom
                [8 ] Southampton Clinical Trials Unit University of Southampton and University Hospital Southampton NHS Foundation Trust Southampton United Kingdom
                [9 ] Institute of Population Health Sciences University of Newcastle Newcastle upon Tyne United Kingdom
                [10 ] Dementia Research Centre University College London London United Kingdom
                [11 ] Department of Psychiatry University of Oxford Oxford United Kingdom
                [12 ] Department of Public Health and Primary Care University of Cambridge Cambridge United Kingdom
                [13 ] Southern Health NHS Foundation Trust Southampton United Kingdom
                [14 ] Public and Patient Involvement (PPI) representative University of Southampton Southampton United Kingdom
                [15 ] School of Psychological Science University of Bristol Bristol United Kingdom
                Author notes
                Corresponding Author: Kirsten Ailsa Smith kirsten.smith@ 123456soton.ac.uk
                Author information
                ©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. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 20.11.2020.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 27 March 2020
                : 12 June 2020
                : 4 August 2020
                : 16 August 2020

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


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