Smith Kirsten Ailsa, Bradbury Katherine, Essery Rosie, Pollet Sebastien, Mowbray Fiona, Slodkowska-Barabasz Joanna, Denison-Day James, Hayter Victoria, Kelly Jo, Somerville Jane, Zhang Jin, Grey Elisabeth, Western Max, Ferrey Anne E, Krusche Adele, Stuart Beth, Mutrie Nanette, Robinson Sian, Yao Guiqing Lily, Griffiths Gareth, Robinson Louise, Rossor Martin, Gallacher John, Griffin Simon, Kendrick Tony, Rathod Shanaya, Gudgin Bernard, Phillips Rosemary, Stokes Tom, Niven John, Little Paul, Yardley Lucy
Centre for Community and Clinical Applications of Health Psychology, University of Southampton, Southampton, United Kingdom.
Primary Care and Population Sciences, University of Southampton, Southampton, United Kingdom.
JMIR Res Protoc. 2020 Nov 20;9(11):e18929. doi: 10.2196/18929.
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.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/18929.
增加身体活动、改善饮食以及进行大脑训练练习与老年人认知能力下降的减缓有关。
在本文中，我们描述了“活跃大脑”干预措施的可行性试验，这是一种基于网络的数字干预措施，旨在支持老年人做出这三项与改善认知健康相关的健康行为改变。“活跃大脑”试验是一项随机可行性试验，将测试“活跃大脑”干预措施的可及性、可接受性和可行性，以及我们打算在规模更大的主要试验中使用的研究程序的有效性。
在随机对照试验（RCT）中，我们采用平行设计。我们将对2018年至2019年通过英国全科医生诊所（家庭诊所）招募的两类人群进行干预：有认知能力下降迹象的老年人和没有任何认知能力下降的老年人。试验参与者被随机分配到3个研究组中的一组：常规护理组、“活跃大脑”干预组或“活跃大脑”网站组加上来自经过培训的教练（通过电话或电子邮件）的简短支持。主要结局指标是认知任务表现、生活质量（使用欧洲五维健康量表5级）、日常生活工具性活动以及痴呆症诊断。还将收集次要结局指标（包括抑郁、赋能和医疗保健成本）和过程指标（包括对参与者和支持者的定性访谈）。该试验已获得英国国家医疗服务体系研究伦理委员会批准（参考编号17/SC/0463）。
研究结果将发表在同行评审期刊上，在会议上展示，并在公众参与活动中分享。数据收集于2020年5月完成，结果将于2021年公布。
本研究的结果将帮助我们在进入主要的随机III期试验之前，识别并对网站、所获得的支持或研究程序做出重要改变。
国际标准随机对照试验编号23758980；http://www.isrctn.com/ISRCTN23758980。
国际注册报告识别码（IRRID）：DERR1-10.2196/18929。
