Online cognitive training for people with cognitive impairment following SARS-CoV-2 infection: A randomised controlled clinical trial
Abstract:
Research question:
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.