The Active Brains Digital Intervention to Reduce Cognitive Decline in Older Adults: Protocol for a Feasibility Randomized Controlled Trial.
dementia
feasibility studies
geriatrics
internet-based intervention
randomized controlled trial
telemedicine
Journal
JMIR research protocols
ISSN: 1929-0748
Titre abrégé: JMIR Res Protoc
Pays: Canada
ID NLM: 101599504
Informations de publication
Date de publication:
20 Nov 2020
20 Nov 2020
Historique:
received:
27
03
2020
accepted:
16
08
2020
revised:
04
08
2020
entrez:
20
11
2020
pubmed:
21
11
2020
medline:
21
11
2020
Statut:
epublish
Résumé
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. International Standard Randomized Controlled Trial Number 23758980; http://www.isrctn.com/ISRCTN23758980. DERR1-10.2196/18929.
Sections du résumé
BACKGROUND
BACKGROUND
Increasing physical activity, improving diet, and performing brain training exercises are associated with reduced cognitive decline in older adults.
OBJECTIVE
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
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
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
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
BACKGROUND
International Standard Randomized Controlled Trial Number 23758980; http://www.isrctn.com/ISRCTN23758980.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
UNASSIGNED
DERR1-10.2196/18929.
Identifiants
pubmed: 33216010
pii: v9i11e18929
doi: 10.2196/18929
pmc: PMC7718093
doi:
Types de publication
Journal Article
Langues
eng
Pagination
e18929Subventions
Organisme : Medical Research Council
ID : MC_UU_00006/6
Pays : United Kingdom
Organisme : Medical Research Council
ID : MC_UU_12015/4
Pays : United Kingdom
Organisme : Medical Research Council
ID : MR/L023784/2
Pays : United Kingdom
Informations de copyright
©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.
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