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The active brains digital intervention to reduce cognitive decline in older adults: Protocol for a feasibility randomized controlled trial

The active brains digital intervention to reduce cognitive decline in older adults: Protocol for a feasibility randomized controlled trial
The active brains digital intervention to reduce cognitive decline in older adults: Protocol for a feasibility randomized controlled trial

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.

Dementia, Feasibility studies, Geriatrics, Internet-based intervention, Randomized controlled trial, Telemedicine
Smith, Kirsten
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Bradbury, Katherine
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Essery, Rosie
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Pollet, Sebastien
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Mowbray, Fiona
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Slodkowska-Barabasz, Joanna
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Denison-Day, James
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Hayter, Victoria
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Kelly, Joanne Marie
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Somerville, Jane
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Zhang, Jin
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Grey, Elisabeth B
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Western, Max
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Ferrey, Anne
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Krusche, Adele
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Stuart, Beth
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Mutrie, Nanette
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Robinson, Sian
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Guiqing, Lily
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Griffiths, Gareth
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Robinson, Louise
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Rossor, Martin N.
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Gallacher, John E.
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Griffin, Simon J.
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Kendrick, Tony
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Rathod, Shanaya
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Gudgin, Bernard
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Phillips, Rosemary
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Stokes, Tom
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Niven, John
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Little, Paul
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Yardley, Lucy
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Smith, Kirsten
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Bradbury, Katherine
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Essery, Rosie
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Pollet, Sebastien
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Mowbray, Fiona
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Slodkowska-Barabasz, Joanna
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Denison-Day, James
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Hayter, Victoria
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Kelly, Joanne Marie
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Somerville, Jane
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Zhang, Jin
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Grey, Elisabeth B
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Western, Max
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Ferrey, Anne
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Krusche, Adele
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Stuart, Beth
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Mutrie, Nanette
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Robinson, Sian
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Guiqing, Lily
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Griffiths, Gareth
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Robinson, Louise
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Rossor, Martin N.
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Gallacher, John E.
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Griffin, Simon J.
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Kendrick, Tony
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Rathod, Shanaya
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Gudgin, Bernard
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Phillips, Rosemary
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Stokes, Tom
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Niven, John
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Little, Paul
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Yardley, Lucy
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Smith, Kirsten, Bradbury, Katherine, Essery, Rosie, Pollet, Sebastien, Mowbray, Fiona, Slodkowska-Barabasz, Joanna, Denison-Day, James, Hayter, Victoria, Kelly, Joanne Marie, Somerville, Jane, Zhang, Jin, Grey, Elisabeth B, Western, Max, Ferrey, Anne, Krusche, Adele, Stuart, Beth, Mutrie, Nanette, Robinson, Sian, Guiqing, Lily, Griffiths, Gareth, Robinson, Louise, Rossor, Martin N., Gallacher, John E., Griffin, Simon J., Kendrick, Tony, Rathod, Shanaya, Gudgin, Bernard, Phillips, Rosemary, Stokes, Tom, Niven, John, Little, Paul and Yardley, Lucy (2020) The active brains digital intervention to reduce cognitive decline in older adults: Protocol for a feasibility randomized controlled trial. JMIR Research Protocols, 9 (11), [18929]. (doi:10.2196/18929).

Record type: Article

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.

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Accepted/In Press date: 16 August 2020
Published date: 1 November 2020
Additional Information: Funding Information: Intervention with Support group: Participants will additionally be provided with support from trained supported from the university of Southampton. These are members of the research team who have completed brief web-based training in the CARE approach. The CARE (Congratulate, Ask, Reassure, Encourage) approach is intended provide support to patients based on Self-Determination Theory. Supporters will also offer technical support. Funding Information: This work was supported by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research (Reference Number RP-PG-0615-20014). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. Funding Information: The Active Brains intervention was developed using Life Guide software, which was partly funded by the NIHR Southampton Biomedical Research Centre (BRC). Funding Information: The research program of LY is partly supported by NIHR Applied Research Collaboration-West, NIHR Health Protection Research Unit for Behavioral Science and Evaluation, and the NIHR Southampton BRC. Funding Information: The research program of MR is supported by the NIHR University College London Hospitals BRC. Publisher Copyright: © 2020 JMIR Publications. All rights reserved.
Keywords: Dementia, Feasibility studies, Geriatrics, Internet-based intervention, Randomized controlled trial, Telemedicine

Identifiers

Local EPrints ID: 443886
URI: http://eprints.soton.ac.uk/id/eprint/443886
PURE UUID: f8856164-14e7-482b-b113-bd856161b8af
ORCID for Katherine Bradbury: ORCID iD orcid.org/0000-0001-5513-7571
ORCID for Sebastien Pollet: ORCID iD orcid.org/0000-0001-9924-9225
ORCID for Fiona Mowbray: ORCID iD orcid.org/0000-0002-3297-4163
ORCID for James Denison-Day: ORCID iD orcid.org/0000-0003-0223-0005
ORCID for Jin Zhang: ORCID iD orcid.org/0000-0001-9583-6000
ORCID for Beth Stuart: ORCID iD orcid.org/0000-0001-5432-7437
ORCID for Gareth Griffiths: ORCID iD orcid.org/0000-0002-9579-8021
ORCID for Tony Kendrick: ORCID iD orcid.org/0000-0003-1618-9381
ORCID for Paul Little: ORCID iD orcid.org/0000-0003-3664-1873
ORCID for Lucy Yardley: ORCID iD orcid.org/0000-0002-3853-883X

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Date deposited: 16 Sep 2020 16:34
Last modified: 19 Sep 2024 01:55

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Contributors

Author: Kirsten Smith
Author: Rosie Essery
Author: Fiona Mowbray ORCID iD
Author: Victoria Hayter
Author: Jane Somerville
Author: Jin Zhang ORCID iD
Author: Elisabeth B Grey
Author: Max Western
Author: Anne Ferrey
Author: Adele Krusche
Author: Beth Stuart ORCID iD
Author: Nanette Mutrie
Author: Sian Robinson
Author: Lily Guiqing
Author: Louise Robinson
Author: Martin N. Rossor
Author: John E. Gallacher
Author: Simon J. Griffin
Author: Tony Kendrick ORCID iD
Author: Shanaya Rathod
Author: Bernard Gudgin
Author: Rosemary Phillips
Author: Tom Stokes
Author: John Niven
Author: Paul Little ORCID iD
Author: Lucy Yardley ORCID iD

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