Dataset Information

The Active Brains Digital Intervention to Reduce Cognitive Decline in Older Adults: Protocol for a Feasibility Randomized Controlled Trial.

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.

Trial registration: International Standard Randomized Controlled Trial Number 23758980; http://www.isrctn.com/ISRCTN23758980.

International registered report identifier (irrid): DERR1-10.2196/18929.

SUBMITTER: Smith KA

PROVIDER: S-EPMC7718093 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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The Active Brains Digital Intervention to Reduce Cognitive Decline in Older Adults: Protocol for a Feasibility Randomized Controlled Trial.

Smith Kirsten Ailsa KA Bradbury Katherine K Essery Rosie R Pollet Sebastien S Mowbray Fiona F Slodkowska-Barabasz Joanna J Denison-Day James J Hayter Victoria V Kelly Jo J Somerville Jane J Zhang Jin J Grey Elisabeth E Western Max M Ferrey Anne E AE Krusche Adele A Stuart Beth B Mutrie Nanette N Robinson Sian S Yao Guiqing Lily GL Griffiths Gareth G Robinson Louise L Rossor Martin M Gallacher John J Griffin Simon S Kendrick Tony T Rathod Shanaya S Gudgin Bernard B Phillips Rosemary R Stokes Tom T Niven John J Little Paul P Yardley Lucy L

JMIR research protocols 20201120 11

<h4>Background</h4>Increasing physical activity, improving diet, and performing brain training exercises are associated with reduced cognitive decline in older adults.<h4>Objective</h4>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 acces ...[more]

PMID: 33216010

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Project description:BackgroundThe SINgapore GERiatric intervention study to reduce cognitive decline and physical frailty (SINGER) randomised controlled trial (RCT) uses a multidomain lifestyle interventions approach, shown to be effective by the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) trial, to delay cognitive decline.ObjectiveTo investigate the efficacy and safety of the SINGER multidomain lifestyle interventions in older adults at risk for dementia to delay cognitive decline.Participants1200 participants between 60-77 years old, with Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) dementia risk score ≥6, fulfilling at least one of the following LIBRA index for diet, cognitive activity, physical activity and a Montreal Cognitive Assessment (MoCA) score ≥18, ≤27 points, will be recruited across Singapore.MethodsSINGER is a 2-year multi-site RCT consisting of multidomain interventions: dietary advice, exercise, cognitive training, and vascular risk factors management. Participants will be randomised into either the Self-Guided Intervention (SGI; general lifestyle and health information and resources) or Structured Lifestyle Intervention (SLI) group. The SLI comprises diet training (6 group and 3 individual sessions over 12 months); exercise (supervised: 1-hour twice weekly for 6 months, unsupervised: 2-3/week for the rest of the study duration); cognitive sessions (15-30 minutes/session, 3/week for 6 months, together with 10 workshops in 24 months). Vascular management takes place every 3-6 months or otherwise as specified by study physicians. The primary outcome is global cognition measured using the modified Neuropsychological Battery assessing performance in various domains, such as episodic memory, executive function and processing speed. Secondary outcome measures include: domain-specific cognition and function, imaging evidence of brain and retinal changes, incidence and progression of chronic diseases, blood biomarkers, quality of life, mental health and cost-benefit analysis.ConclusionsSINGER is part of the Worldwide-FINGERS international network, which is at the forefront of harmonizing approaches to effective non-pharmacological interventions in delaying cognitive decline in older adults at risk of dementia. By establishing the efficacy of multidomain interventions in preventing cognitive decline, SINGER aims to implement the findings into public health and clinical practices by informing policy makers, and guiding the design of community- and individual-level health promotion initiatives.

Project description:BackgroundChronic pain (CP) and cognitive decline (CD) are costly, challenging to treat, prevalent among older adults, and worsen each other over time. We are iteratively developing Active Brains-Fitbit (AB-F), a live video program for older adults with CP and CD that teaches mind-body skills and gradual increases in step count. AB-F has demonstrated feasibility; acceptability; and signs of improvement in emotional, physical, and cognitive functions when delivered in person to older adults.ObjectiveWe are conducting a feasibility randomized controlled trial (RCT) of AB-F versus a time- and dose-matched educational control (health enhancement program [HEP]) in older adults with CP and CD. Here, we describe virtual adaptions to our study protocol, manualized treatments, evaluation plan, and study design in response to feedback from former participants and COVID-19. We will evaluate the feasibility benchmarks and the potential of AB-F to improve physical, emotional, and cognitive functions.MethodsThis is a single-blind pilot RCT. Participants are randomized to AB-F or HEP. Patients are recruited through pain clinic referrals, institutional registries, and flyers. Interested participants are screened for eligibility via telephone and provide electronic informed consent. After randomization, participants are mailed all study documents, including their treatment manual, an ActiGraph accelerometer, and a Fitbit (separate envelope for AB-F only). Both conditions are manualized and delivered over 8 weekly sessions via Zoom. Participants complete self-report and performance-based (6-min walk test and Montreal Cognitive Assessment) outcome measures via Zoom at baseline and post intervention. Primary outcomes are a priori set feasibility (recruitment, quantitative measures, and adherence), acceptability, credibility, expectancy, and satisfaction benchmarks. Secondary outcomes are physical, cognitive, and emotional functions as well as intervention targets (social function, pain intensity, pain-specific coping, and mindfulness).ResultsThe trial is ongoing. We have recruited 21 participants (10 AB-F and 11 HEP) across 2 rounds. Only 2 participants have withdrawn (1 before baseline and 1 before the first session). All 19 remaining participants have completed the baseline assessment. In the first round, attendance is high (11 out of 12 participants completed all 4 sessions so far), and AB-F participants are adherent to their Fitbit and step goals (5 out of 6 participants).ConclusionsPreliminary findings are promising for the feasibility of our completely virtual AB-F intervention. However, these findings need to be confirmed at the trial conclusion. This study will answer important questions about the feasibility of delivering a completely virtual mind-body activity program to older adults with comorbid CP and CD, which, to our knowledge, is unprecedented. Details on integrating multiple digital platforms for virtual assessments and intervention delivery will inform treatment development for older adults and those with comorbid CP and CD, which is crucial during the COVID-19 pandemic.Trial registrationClinicalTrials.gov NCT04044183; https://clinicaltrials.gov/ct2/show/NCT04044183.International registered report identifier (irrid)DERR1-10.2196/25351.

Project description:BackgroundBy 2050, worldwide dementia prevalence is expected to triple. Affordable, scalable interventions are required to support protective behaviours such as physical activity, cognitive training and healthy eating. This paper outlines the theory-, evidence- and person-based development of 'Active Brains': a multi-domain digital behaviour change intervention to reduce cognitive decline amongst older adults.MethodsDuring the initial planning phase, scoping reviews, consultation with PPI contributors and expert co-investigators and behavioural analysis collated and recorded evidence that was triangulated to inform provisional 'guiding principles' and an intervention logic model. The following optimisation phase involved qualitative think aloud and semi-structured interviews with 52 older adults with higher and lower cognitive performance scores. Data were analysed thematically and informed changes and additions to guiding principles, the behavioural analysis and the logic model which, in turn, informed changes to intervention content.ResultsScoping reviews and qualitative interviews suggested that the same intervention content may be suitable for individuals with higher and lower cognitive performance. Qualitative findings revealed that maintaining independence and enjoyment motivated engagement in intervention-targeted behaviours, whereas managing ill health was a potential barrier. Social support for engaging in such activities could provide motivation, but was not desirable for all. These findings informed development of intervention content and functionality that appeared highly acceptable amongst a sample of target users.ConclusionsA digitally delivered intervention with minimal support appears acceptable and potentially engaging to older adults with higher and lower levels of cognitive performance. As well as informing our own intervention development, insights obtained through this process may be useful for others working with, and developing interventions for, older adults and/or those with cognitive impairment.

Project description:BACKGROUND:The treatment and management of long-term health conditions is the greatest challenge facing health systems around the world today. Innovative approaches to patient care in the community such as Anticipatory Care Planning (ACP), which seek to help with the provision of high-quality comprehensive care to older adults at risk of functional decline, require evaluation. This study will evaluate one approach that will include primary care as the setting for ACP. METHODS/DESIGN:This study will help to determine the feasibility for a definitive randomised trial to evaluate the implementation and outcomes of an ACP intervention. The intervention will be delivered by specially trained registered nurses in a primary care setting with older adults identified as at risk of functional decline. The intervention will comprise: (a) information collection via patient assessment; (b) facilitated informed dialogue between the patient, family carer, general practitioner and other healthcare practitioners; and, (c) documentation of the agreed support plan and follow-up review dates. Through a structured consultation with patients and their family carers, the nurses will complete a mutually agreed personalised support plan. DISCUSSION:This study will determine the feasibility for a full trial protocol to evaluate the implementation and outcomes of an (ACP) intervention in primary care to assist older adults aged 70?years of age or older and assessed as being at risk of functional decline. The study will be implemented in two jurisdictions on the island of Ireland which employ different health systems but which face similar health challenges. This study will allow us to examine important issues, such as the impact of two different healthcare systems on the health of older people and the influence of different legislative interpretations on undertaking cross jurisdictional research in Ireland. PROTOCOL VERSION:Version 1, 17 September 2019. TRIAL REGISTRATION:Clinicaltrials.gov, ID: NCT03902743. Registered on 4 April 2019.

Project description:BackgroundOsteoarthritis is a highly prevalent condition in older adults, that causes many sufferers to require a hip or knee replacement in order to improve their quality of life and reduce pain. Individuals waiting for hip or knee replacements are often highly sedentary; thus, it is pertinent to assess whether reducing their sedentariness prior to surgery may aid in improving post-operative outcomes.Methods/designThe study will be a randomised controlled feasibility trial design, with 2:1 randomisation into an intervention and usual care group respectively. A target of 45 patients aged 60?years or older waiting for elective hip and knee replacements will be recruited from Russells Hall Hospital, Dudley, UK, approximately 8-10?weeks before surgery. The intervention, informed by Self-Determination Theory (SDT), will be composed of multiple behaviour change techniques, namely, motivational interviewing, feedback on current objectively measured sedentary behaviour and activity, goal-setting, environmental modification, self-monitoring, and social support. Assessments will occur at baseline, 1?week pre-surgery, and 6?weeks post-surgery. The primary outcome will be the feasibility of intervention delivery and of the trial procedures, assessed quantitatively based on rates of recruitment, retention, measures-completion, and intervention fidelity assessment, and with mixed-methods assessment of acceptability, practicality, adaption, satisfaction, and safety. Exploratory outcomes will include physical function, cardiometabolic biomarkers, measurement of SDT constructs, and both objective and subjective measurement of physical activity and sedentariness. The study will last up to 18?weeks per participant. No formal between-group comparisons are planned, but the variance in within-group changes and differences between groups in outcome measures will be explored and reported with 95% confidence intervals.DiscussionThis is the first study assessing the feasibility of an intervention to reduce sedentary behaviour in older adults with mobility limitations, and the first to assess whether such a reduction could work in a prehabilitative context prior to surgery. The results of this study will help inform the design of a definitive randomised controlled trial.Trial registrationThis trial is registered on Clinicaltrials.gov. Registration number: NCT03740412. Date of registration: 13/11/2018.

Project description:IntroductionDelayed neurocognitive recovery, also identified as early postoperative cognitive decline (POCD), is a common complication after surgery, with advanced age being the most important risk factor. As the geriatric population is increasing worldwide, and number of older adults undergoing surgery continues to rise, so will the incidence of POCD. Only a small proportion use digital cognitive tests for measuring postoperative neurocognitive performance compared with analogue tests. This study aims to evaluate a digital cognitive screening tool, Mindmore Postoperative version (Mindmore-P), in a perioperative setting to determine its feasibility and usability, and to compare preoperative cognition with early postoperative neurocognitive performance. Further, to determine associations between neurocognitive performance and perioperative factors as well as to explore patients' experiences of early neurocognitive recovery.Methods and analysisWe will include 50 patients (aged ≥60 years) undergoing elective abdominal surgery under general anaesthesia. Cognitive functions will be measured with Mindmore-P preoperatively and on postoperative day (POD) 1 or 2 as well as 2-3 weeks after surgery. Preoperatively, frailty, (Clinical Frailty Scale), depression (Geriatric Depression Scale-15), functional status (12-item WHO Disability Assessment Schedule 2.0) and pre-recovery status (Swedish web version Quality of Recovery Scale, SwQoR) will be measured. Delirium will be assessed by Nu-DESC (Nursing Delirium Screening Scale) twice a day, with start on POD 1 and until the patient is discharged from the hospital. Outcomes at 2-3 weeks postoperatively are postoperative recovery (SwQoR), depression, functional status and usability (System Usability Scale) of Mindmore-P. Postoperative recovery will also be measured POD 1 or 2. We will also explore feasibility and experience of early postoperative neurocognitive recovery with interviews approximately 1 month after surgery.Ethics and disseminationThis study is approved by the Swedish Ethical Review Authority (REC Reference: 2022-03593-01) and will follow the principles outlined in the 1964 Helsinki Declaration and its later amendments. Results from this study will be disseminated in peer-reviewed journals, scientific conferences and in social media.Trial registration numberNCT05564195.

Dataset Information

The Active Brains Digital Intervention to Reduce Cognitive Decline in Older Adults: Protocol for a Feasibility Randomized Controlled Trial.

Publications

The Active Brains Digital Intervention to Reduce Cognitive Decline in Older Adults: Protocol for a Feasibility Randomized Controlled Trial.

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