Currently submitted to: JMIR Research Protocols
Date Submitted: Mar 27, 2020
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Active Brains: Protocol for a Feasibility Randomised Control Trial of a Digital Intervention to Reduce Cognitive Decline in Older Adults
Increasing physical activity, improving diet and doing 'brain training' exercises are associated with reduced cognitive decline in older adults. Here we describe a feasibility trial of the Active Brains intervention, an online digital intervention developed to support older adults to make these three healthy behaviour changes associated with cognitive health.
The Active Brains trial is a randomised feasibility trial that will test how accessible, acceptable and feasible the Active Brains intervention is and the effectiveness of the study procedures that we plan to use in our larger main trial.
We will be trialling the intervention with two populations: 1) older adults with signs of cognitive decline, 2) older adults without any cognitive decline. Trial participants will be randomly allocated to one of three study groups: 1) usual care or 2) the Active Brains intervention, or 3) 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 EQ-5D-5L), Instrumental Activities of Daily Living and diagnoses of dementia. Secondary outcomes (including depression, enablement and healthcare costs) and process measures (including qualitative interviews with participants and supporters) will also be collected.
Results will be published in peer-reviewed journals, presented at conferences and shared at public engagement events.
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. Clinical Trial: Trial registration number: ISRCTN 23758980
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