Title: REducing Common infections in Usual practice for Recurrent Respiratory tract infections. (RECUR)
Funder: Department of Health and Social Care

Abstract: 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 &ndash; 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.

Lay abstract: Background. Infections are the most common reason for people to be off work, largely due to Respiratory tract infections (RTIs: colds;sore throats; sinus, chest, or ear infections). Some people experience recurrent infections which has a big impact upon life. These people are also more likely to get antibiotics. Due to the dangers of antibiotic resistance (where antibiotics don t work), alternatives are needed. There is promising evidence that using nasal sprays, or alternatively reducing stress and increasing exercise, could reduce how severe illnesses are and how long they last. Aim. To develop and test promising treatments to reduce how long recurrent infections last and how sever they are. This programme of work will consist of 3 workstreams; WS (Workstream) 1 WS1 has three components. We will interview patients who have experienced recurrent infections. The purpose of these interviews is to help us to understand the barriers which might prevent people from using nasal sprays or prevent them from taking more exercise or managing their stress. We will develop an internet support programme which will provide advice around managing stress and also increasing exercise. Finally, we will conduct a small feasibility study with about 250 participants who suffer with recurrent infections to make sure that people engage in using nasal sprays and the internet programme. WS2 main study This is the main study and just like the feasibility study, patients will be allocated into one of four Groups; 1. Brief standardised advice 2. Saline Nasal spray which rinses and moisturises the nostrils 3. Antiviral nasal spray (Vick s First Defense) which potentially could help manage the symptoms and reduce the risk of recurrence 4. Internet based management to help stress and increase exercise with support from a facilitator We will follow up patients over one winter and spring (6 months) with a final follow-up at 1 year to see if participants develop infections and how severe and long lasting they are. The study will be large enough to look at the benefit in the subgroup of people who are particularly affected by recurrent infections (e.g. patients with chronic lung or sinus problems). WS1 and 2 are closely linked with each other and with the health economic work-package. WS3. Health Economics We will estimate whether the cost of the interventions is worthwhile and good value for the NHS Dissemination: We will disseminate results through journals; professional publications; social media; stakeholder events; PPI collaborators; and NICE. Our PPI collaborators will lead by drafting the media statements; plan for dissemination activities and dissemination channels (with input from coPIs, the broader panel and coapplicants); determine the timing and nature of any more formal stakeholder events; and will have a prominent role in coordinating such events.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING;7.3 MANAGEMENT AND DECISION MAKING
Health categories: INFECTION