Online cognitive training for people with cognitive impairment following SARS-CoV-2 infection: A randomised controlled clinical trial
Award Number
NIHR203603Programme
Research for Patient BenefitStatus / Stage
CompletedDates
1 January 2023 -31 December 2024
Duration (calculated)
01 years 11 monthsFunder(s)
NIHRFunding Amount
£335,400.00Funder/Grant study page
NIHRContracted Centre
Royal Devon University Healthcare NHS Foundation TrustPrincipal Investigator
Professor Anne CorbettPI Contact
A.M.J.Corbett@exeter.ac.ukPI ORCID
0000-0003-2015-0316WHO Catergories
Development of novel therapiesEconomic Impact of Dementia
Tools and methodologies for interventions
Disease Type
Dementia (Unspecified)CPEC Review Info
| Reference ID | 214 |
|---|---|
| Researcher | Reside Team |
| Published | 12/06/2023 |
Data
| Award Number | NIHR203603 |
|---|---|
| Status / Stage | Completed |
| Start Date | 20230101 |
| End Date | 20241231 |
| Duration (calculated) | 01 years 11 months |
| Funder/Grant study page | NIHR |
| Contracted Centre | Royal Devon University Healthcare NHS Foundation Trust |
| Funding Amount | £335,400.00 |
Abstract
What is the impact of the ReaCT cognitive training programme on cognition and other key health-related outcomes in people with cognitive impairment following infection with SARS-CoV-2? Background: Over 255 million people have had Covid-19 globally to date, and cases continue to rise. Whilst the pandemic begins to come under control its most concerning legacy is Long-Covid, or Post-Acute Sequelae of Covid-19 (PASC), which affects at least 9.9% of people. Neuropsychiatric symptoms are common in PASC, with cognitive impairment affecting at least 25% of patients. Cognitive deficits impact on individuals employment, social activity, wellbeing and quality of life. They are also a key risk factor for onward cognitive impairment and dementia particularly in older adults. While pharmacological options are explored for acute cases, there is a need for a low-cost, effective treatment to improve and support cognitive function in individuals with PASC that can be rapidly implemented on a large scale and can be used in both clinical and community settings. Cognitive training offers a means to address cognitive impairment, and digital delivery is a pragmatic and cost-effective way of delivering it to a population. The ReaCT programme is available online and in app format and has established effectiveness in maintaining cognition in older adults. Aims and Objectives: The aim of this study is to establish the effectiveness and cost-effectiveness of the ReaCT cognitive training programme in adults with subjective and established cognitive impairment following infection with SARS-CoV-2. Methods: This will be a six month two-arm placebo-controlled double-blind randomised controlled trial in 608 adults over 40 and a further 1000 adults over 18. Participants over 18 with a laboratory-confirmed case of SARS-CoV-2 infection and subjective cognitive impairment will be recruited through primary care, publicity, social media and an existing ageing research cohort. Participants will register, consent and take part through an app available through their smartphone or mobile device. They will be randomly allocated to receive the ReaCT programme of six evidence-based problem-solving tasks, or a control task with no learning effects. Outcomes will be collected through the app at baseline, three weeks, six weeks and six months. The primary outcome will be cognition measured by the FLAME computerised cognitive test battery, with secondary outcomes of cognition, function, fatigue, mood and quality of life. Service use and employment will be collected to support a health economics analysis. Analysis will follow an intention-to-treat approach in adults over 40 with a secondary analysis with the whole trial population. Timelines for delivery: This will be a 24-month study, encompassing a six-month setup period, six month recruitment window, six month intervention period and ring-fenced time for dissemination, Anticipated Impact and Dissemination: This study will provide evidence to support the roll out of an intervention that is ready-made and fit-for-purpose for rollout. It would rapidly form part of the ongoing public health strategy of interventions to reduce the impact of PASC across the population and would support individuals in regaining their independence and health in the wake of the Covid-19 pandemic.
Plain English Summary
We will conduct a clinical trial to see if playing brain training games helps people who have developed memory problems following infection with Covid-19. Background: The Covid-19 pandemic has dominated our lives for the last two years. Vaccination and better treatments mean that severe infections and deaths are slowing down. However, cases of Covid-19 are still high and many people have longer term problems after they have recovered. This is called Long-Covid. Large numbers of people with Long-Covid experience problems with their brain health, such as memory problems and finding it difficult to pay attention. These symptoms could stop people getting back to work and socialising. They could even increase the risk of developing dementia later in life so it is important that we find a way to treat them. Long-Covid is affecting very large numbers of people so we need to find a treatment that works, is cheap and can be easily given to everyone who needs it. Brain training games are a good option. Our games, ReaCT, have already been proven to improve brain health in adults over 60 but they have not yet been tested in people with Long-Covid. ReaCT games are online and can be played on an app or website free of charge. Design & Methods: This will be a six-month clinical trial of the ReaCT brain training games. We will test the games in 608 people over 40, and a further 1000 people over 18, who have Long Covid and who have problems with their memory. Participants will be recruited through their GPs, publicity, social media and through a UK research study called PROTECT-UK. Participants will download the ReaCT app and will be placed in one of two groups. The ReaCT group will play the brain training games, including games that test your problem-solving and planning skills. The other group will play a simple card-matching game. We will ask participants to complete assessments of their brain health, abilities to perform daily tasks, mood and tiredness. This will tell us whether the ReaCT games improve the health of people with Long Covid. Patient & Public Involvement: This project will be guided by a group of people who have had Covid-19. They will help us to design the information for participants and decide how best to recruit people. We will also work with the PROTECT-UK research study to test the brain training app and make sure it is working properly before we start the trial. Dissemination: We will publish and present our findings for the scientific community, use publicity and social media to communicate to the public and target messages to GPs. This will make sure our research results in real improvements in people s lives.
Aims
`The aim of this study is to establish the effectiveness and cost-effectiveness of the ReaCT cognitive training programme in adults with subjective and established cognitive impairment following infection with SARS-CoV-2.