Recipient organisationHampshire and Isle of Wight Healthcare NHS Foundation Trust
Funding£2.5M
PeriodJul 2019 — Mar 2025
In plain English
AI plain-English summary
People who get three or more respiratory infections a year are being recruited to test whether cheap nasal sprays and online stress-reduction programmes can cut the number of days they spend ill. Recurrent colds, sore throats and chest infections drive antibiotic overuse, fuelling drug-resistant infections. Patients often feel they have no option but to visit a GP and ask for antibiotics. This trial tests two alternatives: a saline nasal spray, an antiviral nasal spray, and an internet-based programme that helps people manage stress and increase physical activity. All three are low-cost and could be used without medical supervision. If any of the interventions work, the impact would be twofold. Patients would spend fewer days sick and miss less work. GPs would write fewer antibiotic prescriptions, slowing the spread of resistance. The study also includes a health-economic analysis that accounts for lost productivity, so the findings could directly inform NHS commissioning decisions and NICE guidance. The trial is large enough to detect benefits in people with chronic lung or sinus conditions, who are hardest hit by recurrent infections.
View original technical description
Background. Infections are the commonest reason for people to be off work with illness, mostly due to Respiratory tract infections (RTIs: colds, sore throats, sinus/chest/ear infections). People with recurrent infections have an even greater impact on quality of life, and are more likely to consult and get antibiotics. Due to the dangers of antibiotic resistance, alternatives to antibiotics, and better strategies for self-management are needed. There is promising evidence that using nasal sprays, or alternatively reducing stress and increasing exercise, could reduce illness severity and duration and improve self-management. Aim. To develop and evaluate interventions for recurrent respiratory tract infections (RTIs). Objective: To estimate the effectiveness and cost-effectiveness of a commonly available nasal spray and a brief physical activity and stress reduction intervention in preventing and reducing the severity and duration of recurrent RTIs. WS (Workstream) 1 We will perform semi-structured face-to-face interviews with 20-25 patients with recurrent RTIs to help identify key behavioural drivers to be addressed in intervention planning – in order to motivate and support using nasal sprays, doing physical activity and using stress reduction techniques. Materials to support nasal sprays, and internet programmes to support the management of distress/stress and increasing physical activity will be developed. The starting point for the internet intervention will be existing applications for other conditions addressing physical activity and stress, but will be adapted for those with recurrent RTIs using our theory-, evidence- and Person-Based Approach to development intervention materials. The acceptability, usability and persuasiveness of draft materials will be tested iteratively with a diversity sample of 20-40 participants, using in-depth face-to-face think aloud interviews. A small feasibility study of around 250 adults who suffer recurrent infections (>=3 RTIs/12 months or >=1 RTI per year over 3 years, and who have had an antibiotic prescription for an RTI in the last 12 months) will ensure people engage in using nasal sprays and the internet programme. WS2 main study 2252 patients will be allocated to one of four groups by random numbers: Brief advice. Saline Nasal spray Antiviral nasal spray (Vick s First Defense) Internet based management to help stress and increase exercise with brief facilitator support Over 6 months, and then with a final follow-up at 12 months, we will document the number of days of illness with RTIs (the primary outcome); illness episodes; expectations about/use of antibiotics; and consultations. The study is powered to document benefit in the subgroups of participants particularly affected by recurrent RTIs (e.g. those with chronic lung or sinus disease). WS3. Health Economics We will estimate the cost-effectiveness of the treatments, taking account of both health and social care costs and the impact in society such as work days lost. Dissemination: informed by our PPI collaborators, qualitative work and process evaluations - through journals; professional publications; social media; stakeholder events; NICE. PPI Two named PPI individuals are integral to protocol development, interpretation of the results and dissemination, supported by input from a larger PPI panel consisting of members of the public and patients who suffer recurrent infections.
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