REGAIN trial intervention development process evaluation data

Background: Up to half of people hospitalised with COVID-19
report diverse and persistent symptoms affecting quality of life for
months and sometimes years after discharge (long-COVID). We describe the
development of an online group exercise and behavioural support
intervention for people who continue to experience such physical and/or
emotional health problems more than three months after hospital
discharge. Methods: Intervention development was
informed by the Medical Research Council framework for complex
interventions. Our multidisciplinary team of academics, clinicians, and
people with long-COVID, had collective expertise in the development and
testing of complex interventions. We integrated a bio-psycho-social model
of care drawing on rehabilitation literature for long-term health
conditions and experiences from our pre-pilot study. Multiple stakeholder
meetings were held to refine the intervention which was designed to be
deliverable within the UK National Health Service. We adhere to TIDieR
guidance for transparent and explicit reporting of telehealth
interventions. Results: The final REGAIN online exercise
and behavioural support intervention consisted of an initial 1:1
consultation with a trained practitioner, followed by eight online group
exercise, and six group support, sessions delivered over eight weeks.
Participants could also access an online library of on-demand exercise and
support videos.Conclusions: The final REGAIN intervention,
combining exercise and behavioural support, is fully manualised with clear
pathways to delivery and implementation. It is currently being tested in a
randomised controlled trial. The intervention, developed
with extensive patient and stakeholder engagement, could
be incorporated into existing NHS rehabilitation programmes, should it
prove to be clinically and cost-effective for people with long-COVID.
Trial registration: International Standard Randomised Controlled
Trial Number (ISRCTN) 11466448: Rehabilitation exercise and psychological
support after COVID-19 infection: REGAIN.