Extrait

Background and study aims Bronchiectasis is a long-term condition where the airways are abnormally widened (called bronchial dilatation), resulting in the build-up of mucus that can cause infection in the lungs. Symptoms include a persistent cough and breathlessness. The damage that is caused to the lungs by the condition is permanent. However, there are treatments available that will relieve symptoms and stop the damage from getting any worse. Healthcare providers largely control and manage the disease without documented guidance for patients on when to seek healthcare assistance. Patient self-management plans/tools have been used in other respiratory conditions similar to bronchiectasis, for many years, with improved healthcare outcomes. Although advocated by the National Guidelines, there is no data on the beneficial effects of self-management plans in bronchiectasis. In an on-going collaboration of patients with, and professionals treating, bronchiectasis we have developed the Bronchiectasis Empowerment Tool (BET). This is a one-page action plan, incorporated within a patient-held pack containing concise information about bronchiectasis and optional notepads to encourage patient note taking to gain insight and information about their condition. The tool has been developed in collaboration with patients and healthcare providers and is easy to use with pictographical instructions. It is designed work alongside, rather than to replace, existing care in order to improve the patient’s ability to manage their condition. Our aim is to conduct a study to evaluate the effectiveness and cost-effectiveness of the Bronchiectasis Empowerment Tool (BET) as a support to patients throughout their healthcare journey. We will assess patients’ self-efficacy, which is the confidence patients have in their ability to successfully deal with their condition, using the validated Chronic Disease Self-Efficacy Scale. We will also measure health care contacts; health related quality of life, appropriateness of antibiotic therapy and costs from questionnaires. To add a qualitative dimension pertinent to successful integration to practice we will seek the opinions of patients at the end of the study. Who can participate? Adults (aged at least 18) identified from clinic lists as having bronchiectasis. What does the study involve? Participants are randomly allocated into one of two groups. Those in group 1 (control) receive standard care. Those in group 2 (intervention) also receive standard care but also BET. Patients randomised to the intervention are given the plan documents and are shown how to use BET. All patients are given the British Lung Foundation bronchiectasis information leaflet and British Thoracic Society Physiotherapy Guideline. At the beginning of the study and after 12 months, participants complete the chronic disease self-efficacy scale, lung information needs questionnaire (LINQ), the St Georges Respiratory Questionnaire (a validated respiratory quality of life tool), the Euroqol-5D (EQ5D) (to determine health utility) and resource use questionnaires. In addition, participants complete chronic disease self-efficacy scale, SGRQ, resource use and health utility questionnaires (which should take 10-15 minutes to complete in total) by mail every 3 months. Exacerbation data are obtained from the resource questionnaire. Patients are asked to collect the packet inserts for all antibiotics which will be cross-referenced to antibiotic sensitivities obtained by microbiology records to determine appropriateness of prescriptions. Patients’ views about BET are captured to aid integration using an exit questionnaire and focus groups. What are the possible benefits and risks of participating? Not provided at time of registration Where is the study run from? Norfolk and Norwich University Hospital NHS Trust (UK) When is study starting and how long is it expected to run for? May 2013 to April 2016 Who is funding the study? National Institute for Health Research (UK) Who is the main contact? Ms Clare Brockwell

Critère d'inclusion

• Topic: Primary Care, Respiratory disorders; Subtopic: Respiratory (all Subtopics), Respiratory disorders; Disease: Respiratory, All Diseases

Liens

• isrctn
• ictrp