TY - JOUR
T1 - Determining the clinical and cost-effectiveness of nasal sprays and a physical activity and stress management intervention to reduce respiratory tract infections in primary care
T2 - A protocol for the 'Immune Defence' randomised controlled trial
AU - Vennik, Jane
AU - Geraghty, Adam W.A.
AU - Martinson, Kate
AU - Yardley, Lucy
AU - Stuart, Beth
AU - Moore, Michael
AU - Francis, Nick
AU - Hay, Alastair
AU - Verheij, Theo
AU - Bradbury, Katherine
AU - Greenwell, Kate
AU - Dennison, Laura
AU - Williamson, Sian
AU - Denison-Day, James
AU - Ainsworth, Ben
AU - Raftery, James
AU - Zhu, Shihua
AU - Butler, Christopher
AU - Richards-Hall, Samantha
AU - Little, Paul
N1 - Publisher Copyright:
© 2023 Vennik et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
PY - 2023/7
Y1 - 2023/7
N2 - Background Most adults in the UK experience at least one viral respiratory tract infection (RTI) per year. Individuals with comorbidities and those with recurrent RTIs are at higher risk of infections. This can lead to more severe illness, worse quality of life and more days off work. There is promising evidence that using common nasal sprays or improving immune function through increasing physical activity and managing stress, may reduce the incidence and severity of RTIs. Methods and design Immune Defence is an open, parallel group, randomised controlled trial. Up to 15000 adults from UK general practices, with a comorbidity or risk factor for infection and/or recurrent infections (3 or more infections per year) will be randomly allocated to i) a gel-based nasal spray designed to inhibit viral respiratory infections; ii) a saline nasal spray, iii) a digital intervention promoting physical activity and stress management, or iv) usual care with brief advice for managing infections, for 12 months. Participants will complete monthly questionnaires online. The primary outcome is the total number of days of illness due to RTIs over 6 months. Key secondary outcomes include: days with symptoms moderately bad or worse; days where work/normal activities were impaired; incidence of RTI; incidence of COVID-19; health service contacts; antibiotic usage; beliefs about antibiotics; intention to consult; number of days of illness in total due to respiratory tract infections over 12 months. Economic evaluation from an NHS perspective will compare the interventions, expressed as incremental cost effectiveness ratios. A nested mixed methods process evaluation will examine uptake and engagement with the interventions and trial procedures. Trial status Recruitment commenced in December 2020 and the last participant is expected to complete the trial in April 2024. Discussion Common nasal sprays and digital interventions to promote physical activity and stress management are low cost, accessible interventions applicable to primary care. If effective, they have the potential to reduce the individual and societal impact of RTIs.
AB - Background Most adults in the UK experience at least one viral respiratory tract infection (RTI) per year. Individuals with comorbidities and those with recurrent RTIs are at higher risk of infections. This can lead to more severe illness, worse quality of life and more days off work. There is promising evidence that using common nasal sprays or improving immune function through increasing physical activity and managing stress, may reduce the incidence and severity of RTIs. Methods and design Immune Defence is an open, parallel group, randomised controlled trial. Up to 15000 adults from UK general practices, with a comorbidity or risk factor for infection and/or recurrent infections (3 or more infections per year) will be randomly allocated to i) a gel-based nasal spray designed to inhibit viral respiratory infections; ii) a saline nasal spray, iii) a digital intervention promoting physical activity and stress management, or iv) usual care with brief advice for managing infections, for 12 months. Participants will complete monthly questionnaires online. The primary outcome is the total number of days of illness due to RTIs over 6 months. Key secondary outcomes include: days with symptoms moderately bad or worse; days where work/normal activities were impaired; incidence of RTI; incidence of COVID-19; health service contacts; antibiotic usage; beliefs about antibiotics; intention to consult; number of days of illness in total due to respiratory tract infections over 12 months. Economic evaluation from an NHS perspective will compare the interventions, expressed as incremental cost effectiveness ratios. A nested mixed methods process evaluation will examine uptake and engagement with the interventions and trial procedures. Trial status Recruitment commenced in December 2020 and the last participant is expected to complete the trial in April 2024. Discussion Common nasal sprays and digital interventions to promote physical activity and stress management are low cost, accessible interventions applicable to primary care. If effective, they have the potential to reduce the individual and societal impact of RTIs.
UR - http://www.scopus.com/inward/record.url?scp=85164760897&partnerID=8YFLogxK
U2 - 10.1371/journal.pone.0285693
DO - 10.1371/journal.pone.0285693
M3 - Article
C2 - 37450460
AN - SCOPUS:85164760897
SN - 1932-6203
VL - 18
JO - PLoS ONE
JF - PLoS ONE
IS - 7
M1 - e0285693
ER -