Extrait

Background and study aims Bronchiectasis is a lung condition in which the airways become permanently damaged. People who have bronchiectasis can have many different chest symptoms, commonly produce a large amount of phlegm and experience many chest infections. Pseudomonas aeruginosa is a bacterium (bug) that is found in the phlegm of almost a third of bronchiectasis patients. These patients require more antibiotics, are admitted to hospital more and attend more clinic appointments than patients without this bug. Colistimethate sodium and tobramycin are antibiotics that are breathed directly into the lungs using a nebuliser. They are known as inhaled antibiotics. They are effective at treating P. aeruginosa infection, yet patients continue to have repeated infections requiring further antibiotics. This may be because patients do not take their inhaled antibiotics as they have been prescribed. This is described as non-adherence. Research conducted at Queen’s University Belfast found that among patients who were prescribed inhaled antibiotics for P. aeruginosa infection, 53% took their antibiotics as prescribed (adherent). Adherence to inhaled antibiotics was also linked with having fewer infections (adherent patients had 2.6 exacerbations [chest infections] per year whereas non-adherent patients had 4). A new approach to support people with bronchiectasis to take their inhaled antibiotics has been developed. This approach has been developed using a recommended process for developing ways to change people’s behaviour to improve their health. This study aims to test if the intervention can be delivered as intended to patients with bronchiectasis, and whether or not patients consider it to be an acceptable and useful form of support. Who can participate? People aged over 18 who have been diagnosed with bronchiectasis and who have been prescribed the medicine Colistimethate Sodium (also known as Colomycin®) What does the study involve? The study involves testing the new approach with five participants recruited from the Regional Respiratory Centre at the Belfast Health and Social Care Trust. The participants meet with a researcher three times (Visits 1-3) at a dedicated Clinical Research Facility at the Belfast City Hospital. At Visit 1, the researcher confirms that the participant is happy to take part in the study. The researcher then asks the participant a number of questions about their treatment plan. The researcher uses the answers to these questions to find out what form of support the participant needs in order to improve their adherence to their inhaled antibiotic. Using this information, the researcher plans what is going to happen in Visit 2. At Visit 2, the researcher uses a manual and supporting materials to provide adherence support that is tailored to the participant. During the visit, an action plan is drawn up for the participant to follow at home. They are also given a diary to help them monitor their treatment. At Visit 3, the participant’s progress is reviewed and the researcher provides further support for adherence if needed. When all three visits have been attended, the researcher telephones each participant and asks them for feedback about their experience. Participants are asked what they liked and disliked about the three visits and if they thought the information and advice they received was a useful form of support. Information is collected from the participant at Visit 1 and around three months later. What are the possible risks and benefits of participating? The main benefit of participating in the study is that participants' adherence may improve. Studies show that people who are adherent to inhaled antibiotics have fewer chest infections than those who are not. Therefore participation in the study could lead to fewer chest infections, a reduced need for antibiotics, fewer admissions to hospital and a better quality of life. By taking part in the study, participants will also be contributing to the body of evidence relating to bronchiectasis. There is a low risk of harm associated with this study. The main risk is the potential for distress when answering questionnaires that cause participants to reflect on their condition. Any potential for harm will be minimised by reviewing the information sheets with the participant before they provide informed consent. Should a participant become distressed at any point in the study, they will be given time to take a break and to decide if they want to proceed. If they do not want to proceed they can withdraw. Their medical team will be notified that they are no longer participating but this will not affect their medical care. Where is the study run from? Belfast Health and Social Care Trust (Belfast City Hospital site) (UK) When is the study starting and how long is it expected to run for? July 2016 to April 2017 Who is funding the study? Queen's University Belfast (UK) Who is the main contact? Prof. Carmel Hughes

Critère d'inclusion

• Suboptimal adherence to inhaled antibiotics in bronchiectasis

Liens

• isrctn