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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
The prevalence of dementia is estimated to be between 5% and 7% among those aged 65 years and above [
Cognitive impairment in the absence of dementia is common, but prevalence estimates vary considerably depending on the definition [
There is mounting evidence that healthy behaviors (particularly physical activity) and cognitive exercises improve cognitive functioning and activities of daily living, and a recent trial from other settings has demonstrated the potential effectiveness of combining healthy behavior and cognitive interventions [
Several large cohort studies and systematic reviews indicate that leisure time physical activity—even at moderate intensity levels—is protective, as is greater fish and fruit and vegetable consumption, with increased risks shown for obesity and high saturated fat intake [
A systematic review of cognitive exercise trials [
Although there is evidence that suggests healthy behavior changes can be protective against cognitive decline, behavioral interventions are complex and resource intensive, if delivered by purely face-to-face methods. In contrast, the internet is now used extensively and successfully by older people for self-management of health [
Recent UK government statistics demonstrate that the proportion of older adults using the internet is rapidly increasing. Among those aged 55 to 64 years, 88.3% reported recent (in the past 3 months) internet use. Although this proportion declines across age groups, this age group has demonstrated the fastest growth. Over the past 7 years, the proportion of adults aged 75 years and above reporting recent internet use has nearly doubled from 20% in 2011 to 47% in 2019 [
The research team has extensive experience of ensuring intervention engagement and accessibility to encompass a range of user preferences [
A large trial (n=2912) led by one of the research team’s coinvestigators (CB) [
Intervening with noncognitively impaired older adults may also prevent dementia. Although an intervention for noncognitively impaired older adults may be expected to have a smaller effect, data from the large ReaCT trial [
The primary aim of this study (
The primary outcome was to investigate the feasibility of collecting clinical outcomes and notes review data. This is built around our stop or go criteria for the proposed full RCT: the project will progress to a full RCT if 80% of the clinical outcome and notes review data from randomized participants are available for analysis. If the figures are 70%-80%, we will discuss our plans for appropriate mechanisms to increase the response rate with the trial steering committee. If less than 70% of the data are available, in negotiation with the funder, we will consider not proceeding to the main trial unless there is a clear and plausible plan to increase response rates or reduce missing data. The feasibility and resource requirements for recruitment will also affect the likelihood of progression to the main trial.
The evaluation of feasibility and acceptability in terms of (1) suitability of recruitment screening methods; (2) acceptability of all trial procedures (eg, recruitment, randomization, study materials, follow-up); (3) recruitment and attrition rates; (4) acceptability of the digital intervention (uptake, usage, attrition, and qualitative process evaluation); (5) appropriateness of the human support module (uptake, adherence, number of sessions, and qualitative process evaluation); (6) suitability of all outcome measures; and (7) Health Economics analysis—the key resources to be collected—to inform the choice of quality of life instruments to be used in the full trial.
We will also explore the analysis of the characteristics of outcomes for power calculations to confirm the target sample size for the trial and preliminary estimates of change in relevant behaviors (based on automatically recorded intervention usage, eg, goals set and reviewed, scores on brain training games).
The randomized controlled study will use a parallel design. Participants will be divided into
Usual care (60 participants from each group).
Access to the Active Brains intervention (60 participants from each group).
Access to the Active Brains intervention with flexible human support from a central support facilitator (60 participants from each group).
It is anticipated that the noncognitively impaired group will recruit more quickly than the cognitive impairment group, due to the low prevalence of MCI and AACD within the age group. Participants exceeding the allocated group size of 180 will not be randomized but will be offered to access the intervention (no support) as part of a cohort group.
Primary care recruitment will involve practice staff inviting patients from searches of UK practice lists based in England (GPs [General Practitioners] will screen practice lists to avoid inviting those who have an existing diagnosis of dementia and who are terminally ill or seriously mentally ill) between October 2018 and January 2019. Participants will also be recruited opportunistically during consultations with practitioners. Invitation letters, participant information sheets, reply slips (for those not interested to inform us why), and a
Randomized controlled trial and pilot study procedure flowchart. AACD: age-associated cognitive decline; MCI: mild cognitive impairment.
When participants first access the Active Brains study website, they will be asked to sign up with a username, password, and their unique ID code (provided on their study invitation letter). They are then presented with the information sheet and web-based consent form to complete. If they consent, they then answer a series of screening questions to ensure that they fit the study inclusion criteria (shown in
Between 60 and 85 years of age
Diagnosis of dementia
Terminal Illness
Serious mental illness
Able and willing to access the internet
Cognitive impairment group: ≥1 SD below the norm on the Baddeley Reasoning Test [
No cognitive impairment group: <1 SD below the norm (or above norm) on the Baddeley Reasoning Test [
High levels of leisure time physical activity (score ≥30 on Godin Leisure Time Exercise Questionnaire [
Another member of the household already participating in the study
Outcome measures and times presented to each group for the Active Brains feasibility trial.
Measure | Time | Group | |||||
|
Baseline | 12-month follow-up | Usual care | Active Brains intervention | Active Brains intervention and support from central facilitator | Nonrandomized cohort study participants (receiving the Active Brains intervention) | |
Sociodemographic data | ✓a | —b | ✓ | ✓ | ✓ | ✓ | |
Clinical and behavioral data | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
Clinical measures (from notes review) | — | ✓ | ✓ | ✓ | ✓ | — | |
Cognitive Performance Tasks [ |
✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
Instrumental Activities of Daily Living [ |
✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
The Patient Enablement Scale [ |
— | ✓ | ✓ | ✓ | ✓ | ✓ | |
International Physical Activity Questionnaire [ |
✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
EQ-5D-5Ld [ |
✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
EQ-5D-5L-proxy version 2 (for contact person completion if required) [ |
— | ✓ | ✓ | ✓ | ✓ | — | |
ICEpop CAPability measure [ |
✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
Short-form Health Survey [ |
✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
Dementia diagnosis (from notes review) | — | ✓ | ✓ | ✓ | ✓ | ✓ | |
Mortality | — | ✓ | ✓ | ✓ | ✓ | — | |
Health economic analysis of cost-effectiveness (from notes review) | — | ✓ | ✓ | ✓ | ✓ | — | |
Food Frequency Questionnaire [ |
✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
Problematic Experiences of Therapy Scale [ |
— | ✓ | — | ✓ | ✓ | ✓ | |
Brief Geriatric Depression Scale [ |
✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
Self-efficacy for exercise [ |
✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
Medical Outcome social support Survey [ |
✓ | — | ✓ | ✓ | ✓ | ✓ | |
Social Support for Exercise [ |
— | ✓ | ✓ | ✓ | ✓ | ✓ | |
Locus of Causation in Exercise [ |
✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
Technology Acceptance Model Perceived Ease of Use scale [ |
— | ✓ | — | ✓ | ✓ | ✓ | |
Informant Questionnaire on Cognitive Decline in the Elderly–short form (if participants do not complete full measures) [ |
— | ✓ | — | ✓ | ✓ | — | |
|
|||||||
|
Use of the Active Brains intervention | — | — | — | ✓ | ✓ | ✓ |
|
|||||||
|
Supporters’ use of Active Brains intervention (throughout the study) | — | — | — | ✓ | ✓ | — |
|
Emails sent to participants throughout the study | — | — | — | ✓ | ✓ | — |
|
|||||||
|
Interviews with patients about their experiences of the study and/or intervention | — | — | ✓ | ✓ | ✓ | — |
|
Interviews with Central Support Facilitators about their experiences of the study and intervention | — | — | ✓ | ✓ | ✓ | — |
a✓: indicates yes.
b—: indicates no.
c“During the last 7 days, on how many days did you do activities or exercises to improve your strength and balance? Examples would be exercises such as standing on one leg, doing repeated sit to stands in a chair, lifting weights or heavy objects at home or at a gym or using resistance bands. Please only include time where you have purposefully decided to do these exercises for improving strength and balance.” Response requested: Number of days and number of hours or minutes on an average day.
dEQ-5D-5L: EuroQol-5D 5 level.
Subgroups of cognitively impaired participants will be identified by combinations of impairment in the Baddeley reasoning cognitive task, IADL, and memory cognitive task. Key subgroups are MCI, which will be defined as 1.5 SD below the norm in a nonmemory cognitive domain plus memory impairment [
Simple randomization will be used to assign participants to intervention arms using the study software’s computer-generated random numbers. Randomization occurs online after a participant completes baseline measures, ensuring blind randomization. They will have an equal chance of being in each of the 3 groups. Once randomized, participants will be informed of their group allocation (they will also be emailed this information). If participants are in one of the treatment arms, they will be taken directly to the Active Brains intervention. These participants can then use the Active Brains intervention as much as they would like to over the course of the study. The central facilitator will be notified by email when a participant is randomized to the support arm of the trial, so that they know to expect to provide support to the participant in the coming weeks. Research staff will not be blinded to the participant group but the statistician and health economists conducting the analyses will be.
At the outset, the project recruited 2 older adult patient and public involvement (PPI) representatives to inform the development of the intervention and trial. They contributed to the development of the protocol and early intervention drafts. When intervention development began, it was determined that further PPI input would be essential to make the intervention and study materials engaging and easy to use. Three older adult representatives were recruited. Their input was invaluable in providing direction and feedback on the content and structure of the intervention (eg, the name, logo, content, order of pages) as well as the consent processes, interview topic guides, screening, and study measures (eg, feedback on unsuitable phrasing, resolving questionnaire burden).
During and after the trial, the PPI representatives will inform the discussion and interpretation of the trial outcomes and process evaluations and provide a patient perspective on resolving problems with recruitment, retention, participant support, and follow-up.
The Active Brains intervention was developed to provide interactive tailored support to older adults in initiating and maintaining evidence-based behaviors that support cognitive and physical health using appropriate behavior change techniques. All intervention content has been iteratively developed with extensive input from the target user group to ensure that it is highly accessible and engaging. The Active Brains study website (containing the consent material and the study measures) is accessible to all participants, with only the intervention arm participants having access to the Active Brains intervention content. For the first 7 months, the intervention groups will have access to the Active Brains “Starter Section,” which provides support for users to initiate changes to their lifestyle in line with the intervention’s recommendations.
Within the first section of the Active Brains intervention, 3 modules will become available to users, released sequentially. Within these modules, users will have access to information addressing common concerns, instructions about recommended activities, guided goal setting and reviewing, personalized motivational feedback about their progress, and motivational reminder emails. The modules are as follows:
Active Lives: a physical activity module that provides guidance on general physical activity, strength and balance exercises, and decreasing sedentary behavior.
Brain Training: access to online
Eat for Health: guidance on healthy eating and increasing intake of foods beneficial for cognitive health.
After 6 months, users will be given access to the Active Brain “Booster Section,” providing further advice on habit formation and additional resources.
1. Brief name
Active Brains Study
2. Why
An aging population places strains on health services: particularly with the increase in dementia. Several lifestyle changes have been found to help protect against cognitive decline. The aim of this study is to develop and test a digital behavior change intervention to help older adults increase their physical activity, improve their diet and practice cognitive 'Brain Training' activities to reduce cognitive decline.
3. What material?
Assessment: All participants will complete web-based questionnaires and complete the four cognitive assessment games at 0 and 12 months
Intervention Group: Participants in this group receive access to the Active Brains digital intervention.
Intervention with support group: Participants in this group will receive the Active Brains digital intervention and additionally will be offered up to eight 10 minute support phone calls with a trained supporter.
Control Group: Participants in this group will receive usual care from their GP and brief web-based advice about getting more active, improving diet and staying mentally active.
The Active Brains Digital Intervention contains 4 sections described below.
Month 0: Active Brains Starter Section. Access to 'Active Lives', including 'Strength and Balance', 'Taking Breaks from Sitting' and 'Getting Active'. These modules contain: Information addressing common concerns; Provision to order a step counter and guidance on using it; User stories modeling overcoming barriers; Instructions about obtaining social support; Suggestions for environment restructuring; Instructions about recommended activities (including Strength and Balance videos); Facilities to set, plan and review goals about their chosen activities; Tailored motivational feedback about their progress; Reminder emails to motivate them to continue with their activities and to revisit intervention content as appropriate.
Month 1: Access to Brain Training. This module provides: Brief information about the rationale and evidence base for Brain Training tasks and how they are intended to work; User stories modeling overcoming barriers; Access to six web-based brain training games (via the existing PROTECT website) which they are encouraged to play between three and five times per week; facilities to set, plan and review goals about their chosen activities; tailored motivational feedback about their progress; reminder emails to motivate them to continue with their activities; Six additional games are made available to users during months 1-6
Month 2: Access to Eat for Health. This module contains: Information on the benefits of healthy eating for cognitive and physical health; Information and techniques to allow them to make healthy changes to their existing eating behaviors (eg, increasing fruit and vegetable consumption, cutting down on processed foods); Facilities to set, plan and review goals about their chosen activities; User stories modeling overcoming barriers; Tailored motivational feedback about their progress; Reminder emails to motivate them to continue with their activities; Recipes
Month 6: Transition to Active Brains Booster Section. This module contains: Tailored summary of their progress and engagement with the Starter Section content; Links to additional resources for additional support and to extend their progress with the behavioral changes made.
The content was developed to support self-efficacy and autonomy. It used simple and accessible language, using persuasive rather than directive phrasing (ie, “you can” rather than “do”), and promoting guided choice rather than direction (eg, offering a range of ideas for goals).
4. What procedure
Screening and randomization: Participants will complete web-based screening to ensure eligibility. Participants will then complete cognitive tasks and the Instrumental activities of daily living (IADL) questionnaire to determine work stream (with or without cognitive impairment). If the assigned work stream is full (capped at n=180), participants will be given access to Active Brains (no support) as part of a cohort study. Participants in each work stream will be randomized to one of the three groups. They will be informed of their group allocation on the website immediately.
Intervention Group: Participants will receive full access to the Active Brains intervention. They will receive regular emails to remind them to access the intervention. They will be sent reminder emails when follow-up measures are available to complete.
Intervention with Support Group: Participants will receive full access to the Active Brains intervention. Participants in this group will additionally be sent emails from an assigned supporter. They will be invited to book phone call appointments to support them with their use of the intervention.
Control Group: Participants will receive basic information online about getting more active, improving diet and staying mentally active. They will be sent reminder emails when follow-up measures are available to complete.
5. Who provided
Assessment: Participants will be invited to take part using a letter from their GP practice. They will access the screening and measures online.
Intervention Group: Participants will use the intervention online.
Intervention with Support group: Participants will additionally be provided with support from trained supported from the university of Southampton. These are members of the research team who have completed brief web-based training in the CARE approach. The CARE (Congratulate, Ask, Reassure, Encourage) approach is intended provide support to patients based on Self-Determination Theory. Supporters will also offer technical support.
6. How
Intervention delivered entirely online.
Follow-up procedures may include telephone and post.
7. Where
Intervention delivered entirely online, intended to be used in the participant's home.
8. When and how much
Intervention Group: The intervention is divided into a 'Starter Section', lasting 6 months and a 'Booster' section provided at 6 months. The starter section unlocks 'Active Lives' at month 0, 'Brain Training' at month 1 and 'Eat for Health' at month 2. Participants will be encouraged to set goals and plans for each section and return to review the goals after one week. After 'Brain Training' unlocks, participants will be encouraged to set a goal to play the games 3-5 times a week until month 6, and then play for 3-5 times a week for a month every 3 months. Initially 6 games will be available with new games unlocking every month until 12 games are available. Participants will be guided to form healthy habits so that after 6 months they will be less reliant on the intervention. For participants with a BMI>30, a weight loss tool 'POWER' will be offered at month 6.
Intervention with support group: In addition to the intervention, these participants will be offered three support phone calls at weeks 2, 6 and 10. They may request up to 8 phone calls in total.
9. Tailoring
The intervention will tailor physical activity recommendations to self-rated Strength and Balance and current physical activity. Participants may then choose any or all of the three physical activity modules.
Strength and balance exercises are tailored to self-rated strength and balance.
The weight loss tool will only be offered to participants with a BMI>30.
Goal review feedback will be tailored to prior performance (the past two review ratings for that module).
10. Modification
The intervention will not be modified during the trial.
11. How well
The intervention was created using the Person-Based Approach (PBA). Experts in digital behavior change oversaw the development. End users were consulted at all points of development and the intervention was iteratively refined to overcome anticipated barriers. The intervention was thoroughly tested by the research team to ensure that there were minimal problems with the software.
Participants will be encouraged to set and review goals every week when using Active Brains. When they unlock “Brain Training,” they will be encouraged to play the games 3 to 5 times per week for the first 6 months. The intervention will be available to the participants for a year. However, the Active Brains intervention aims to help participants establish healthy habits (eg, regular walking) so that participants are not dependent on the intervention in the long term—we anticipate that participants will not need to use the website every week for 6 months to gain benefits from the intervention. The level of engagement that is effective in improving outcomes will be investigated in the main trial.
Patients in the group receiving support from a central facilitator (in addition to the website) will be offered a brief (10 min) telephone support call 2 weeks after they begin the study. In this support call, they will discuss the cognitive or lifestyle changes that they are planning to try. Patients will be offered 2 more support contacts by phone (up to 10 min) or email to support them in making behavioral changes.
Central facilitators will be people trained in the congratulate, ask, reassure, and encourage (CARE) approach to provide support to patients, which is based on Self-Determination Theory [
The comparison group will receive usual care from their GP practice, in addition to brief web-based advice about becoming more physically active, improving the diet, and staying mentally active.
Participants will register, be randomized, and complete baseline measures. Participants in the intervention arm will then be given access to the intervention, which they can use for one year. Participants in the support arms will be invited to have a support call at weeks 2, 6, and 10. A sample of participants will be invited to participate in a qualitative process interview at 6 months. All participants will be invited to complete outcome measures at 12 months.
This is a feasibility trial, so it was not powered to measure patient outcomes. A sample size of 180 for each of the 2 subgroups was chosen for several reasons. As Active Brains is a digital intervention with multiple possible pathways through it, a sufficiently large group would be required to observe different patterns of usage. Fully web-based interventions are easy to recruit and manage larger numbers of participants, making this possible. The proposed fully powered trial would need to recruit over 20,000 patients, so implementation issues and trial processes (eg, managing multiple supporters) needed to be tested at scale. A total of 360 participants would provide robust evidence for the feasibility of the trial.
Outcome measures will be collected by using the software at registration and at one year. It will be held securely in a database accessible only by the data controller and members of the study team. Each participant will be assigned a unique study ID when they register with the website. Anonymous outcome data will be held in a separate write-only database to the personally identifiable data to ensure blinding and guard against modification.
Personally identifiable data will be held in accordance with the General Data Protection Regulation [
The primary analysis will determine whether the feasibility trial has met the stop or go criteria and will therefore describe the completeness of the data in relation to the number of participants recruited.
Data for the secondary analyses will be explored descriptively and graphically for the other key feasibility outcomes, including intervention uptake, adherence, attrition, retention, and the number of participants recruited per practice. We will estimate the variability of proposed outcome measures and discuss any implications for the sample size for the full trial.
All participant data will be analyzed, including those who have withdrawn, unless the participant specifically requests for their data to be removed. All participants will be analyzed as randomized. The pattern and frequency of missing data will be explored descriptively in the feasibility context to determine whether there are whole instruments or items on instruments that participants opted not to complete and to inform the stop or go decision for the full trial.
The same outcomes will be assessed in a cohort study to explore whether it is feasible to recruit additional participants and collect data to inform future implementation in this way.
For the feasibility study, we will provide only descriptive estimates (ie, we will not be performing an inferential analysis to establish whether there are significant differences between groups).
At this feasibility stage, we aim to collect resource usage information associated with the intervention and explore and identify the likely changes in practice due to the intervention through questionnaires, case note review, and qualitative interviews. We plan to develop and refine the methods for collecting such information and to inform the choice of which instrument will be used to measure quality of life for the later planned, fully powered trial.
The study will explore both the National Health Service (NHS) and social service perspectives. All itemized resource usage will be costed using published information (eg, the Personal Social Services Research unit [
The economic analyses of costs and quality of life will be mainly descriptive (with mean and standard deviation). We will correlate all utility scores with the planned primary outcome [
Such information will allow us to investigate the most relevant resource use of information to be collected and inform choice of the quality of life instrument to be used in the definitive trial.
There will be 2 qualitative process studies, one with participants and one with central support facilitators. Interviews in both these studies may be carried out at any time between 2 and 12 months after participants begin the study. Both of these studies will allow assessment of the acceptability and feasibility of the intervention and highlight any modifications to the intervention or study procedures that might be required before embarking on the later planned, fully powered trial.
We will interview 12 to 18 participants from each of the intervention arms, employing purposive sampling to ensure a diverse range of participants in terms of demographic and clinical profiles as well as website usage. Participants will be invited to participate by the research team and asked if they would be willing to take part in a telephone interview. They will complete a separate consent form (online) before taking part in an interview. During the interview, open-ended questions will be used to explore participants’ perceptions of the study, the website (if in one of the intervention groups), and the support they received from the central facilitator (if in the support group). Those in the control group will be asked about the brief advice they were given at baseline.
The second substudy will use face-to-face or telephone interviews to explore central support facilitators’ views of the study procedures, the website, the training they were provided, and the support they provided to patients (including perceptions of the CARE approach).
Data from both qualitative process studies will be analyzed using inductive thematic analysis with interrater agreement reached between team members. The findings will be discussed and interpretations agreed between the coinvestigators (including PPI representatives).
Serious adverse events (SAEs) will be reported by both participants, practice staff, and possibly by the central support facilitators who will have contact with participants during the study. It is not anticipated that SAEs will be related to this research. SAEs are defined as any untoward medical occurrence or effect that at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization (excluding hospitalization for pre-existing conditions or planned procedures), results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or results in other important medical events. Any SAE occurring to a research participant will be reported to the ethics committee where, based on the initial judgement made by the chief investigator or an agreed deputy, the event was related to the administration of any of the research procedures and was an unexpected occurrence. Nonserious adverse events will not be collected.
GP practices and the central support facilitation staff will inform the research team and/or the Clinical Trials Unit of any SAEs within 24 hours of them being aware of the event occurring. GP practices and central support facilitation staff will be provided with a standard operating procedure and a form for SAE reporting. Patients may also report SAEs. Reports of SAEs will be provided to the ethics committee within 15 days of the chief investigator becoming aware of the event. In addition to the chief investigator making the initial judgement about the SAE, all SAEs will also be sent to the trial steering committee for adjudication.
Participants will be fully informed of the risks and benefits of the study and their right to withdraw at any time for any reason. Consent will be collected digitally before data collection.
Ethical approval for the Active Brains study was obtained from the NHS Research Ethics Committee (IRAS ID 239448, REC number 17/SC/0463). Research and development approvals were obtained from relevant clinical research networks.
The results of this trial will be published in peer-reviewed journals and presented at conferences. Findings will be conveyed to the public through press releases and public engagement activities (eg, science fairs). Findings will be sent to all GP practices and participants who request them. Social media (eg, Twitter) will also be used to share publications and dissemination activities to the wider academic community and the general public. If found to be feasible, Active Brains will proceed to a full RCT.
Recruitment for this study was conducted from October 2018 to January 2019. All data were collected and the trial website was closed by May 2020. The analysis will be conducted in 2020, and results will be published in 2021. The prospective main trial will begin in late 2020.
The Active Brains feasibility trial has several strengths. First, the design of the intervention can be easily implemented at scale—this will be useful for the planned larger RCT and, if found to be effective, future dissemination to the public. Second, the development of the intervention used a person-based approach (combining theory, evidence, and primary qualitative research)—this has improved its chance of being acceptable and effective.
Peer reviews of grant application.
age-associated cognitive decline
Biomedical Research Centre
congratulate, ask, reassure, and encourage
instrumental activities of daily living
mild cognitive impairment
National Health Service
National Institute for Health Research
odds ratio
population attributable risk
patient and public involvement
randomized controlled trial
Reasoning and problem-solving Cognitive Training
serious adverse event
This 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.
KS and KB drafted the paper. KS, KB, RE, SP, FB, MW, AF, AK, PL, and LY wrote the protocol. KS, RE, SP, FM, JS, JD, VH, JK, JS, EG, GY, PL, and LY conducted the trial. KS, RE, SP, FM, J Slodkowska-Barabasz, JD, VH, JZ, EG, MW, AF, AK, SR, BG, RP, TS, JN, PL, and LY developed the
None declared.