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
Bibliographical noteThis 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.
The Active Brains intervention was developed using Life Guide software, which was partly funded by the NIHR Southampton Biomedical Research Centre (BRC).
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.
The research program of MR is supported by the NIHR University College London Hospitals BRC.
- Physical and Mental Health
- cognitive health
- digital interventions
- behaviour change
- randomised trial