Evaluation of a novel information resource for patients with bronchiectasis: study protocol for a randomised controlled trial.
BACKGROUND
There is currently little patient information on bronchiectasis, a chronic lung disease with rising prevalence. Previous work shows that patients and their families want more information, which could potentially improve their understanding and self-management. Using interviews and focus groups, we have co-developed a novel patient and carer information resource, aiming to meet their identified needs. The aims and objectives are: 1. To assess the potential impact of the information resource 2. To evaluate and refine the intervention 3. To establish the feasibility of carrying out a multi-centre randomised controlled trial to determine its effect on understanding, self-management and health outcomes


METHODS
This is a feasibility study, with a single-centre, randomised controlled trial design, comparing use of a novel patient information resource to usual care in bronchiectasis. Additionally, patients and carers will be invited to focus groups to discuss their views on both the intervention itself and the trial process. The study duration for each participant will be 3 months from the study entry date. A total of 70 patients will be recruited to the study, and a minimum of 30 will be randomised to each arm. Ten participants (and their carers if applicable) will be invited to attend focus groups on completion of the study visits. Participants will be adults with bronchiectasis diagnosed as per national bronchiectasis guidelines. Once consented, participants will be randomised to the intervention or control arm using random permuted blocks to ensure treatment group numbers are evenly balanced. Randomisation will be web-based. Those randomised to the intervention will receive the information resource (website and booklet) and instructions on its use. Outcome measures (resource satisfaction, resource use and alternative information seeking, quality of life questionnaires, unscheduled healthcare visits, exacerbation frequency, bronchiectasis knowledge questionnaire and lung function tests) will be recorded at baseline, 2 weeks and 3 months.


CONCLUSIONS
All outcome measures will be used in assessing feasibility and acceptability of a future definitive trial. Feasibility outcomes include recruitment, retention and study scale form completion rates. Focus groups will strengthen qualitative data for resource refinement and to identify participant views on the trial process, which will also inform feasibility assessments. Questionnaires will also be used to evaluate and refine the resource.


BACKGROUND
ISRCTN84229105.
Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, NE2 4HH, UK. katy.hester@ncl.ac.uk.
Katy L M
KL
Hester
Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, NE2 4HH, UK.
Julia
J
Newton
Institute of Health and Society, Newcastle University, Newcastle upon Tyne, NE2 4AX, UK.
Tim
T
Rapley
Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, NE2 4HH, UK.|Adult Bronchiectasis service, Freeman Hospital, Newcastle Upon Tyne, NE7 7DN, UK.
Anthony
A
De Soyza
D022126:Access to Information; D001987:Bronchiectasis / Q000175:diagnosis / Q000453:epidemiology / Q000628:therapy*; D017028:Caregivers / Q000523:psychology; D002985:Clinical Protocols; D054626:Consumer Health Information; D004739:England; D005240:Feasibility Studies; D017144:Focus Groups; D063005:Health Information Systems; D007722:Health Knowledge, Attitudes, Practice; D006295:Health Resources; D006801:Humans; D010353:Patient Education as Topic; D017060:Patient Satisfaction; D011379:Prognosis; D012107:Research Design; D012648:Self Care; D011795:Surveys and Questionnaires
Bronchiectasis; Education; Exacerbation; Feasibility study; Information; Qualitative research; Randomised controlled trial; Self-management