Bronchiectasis Information and Education Feasibility (BRIEF) Study

• Research type

  Research Study

• Full title

  Bronchiectasis Information and Education: Feasibility Study and Evaluation of a Novel Resource.

• IRAS ID

  151140

• Contact name

  Katy L M Hester

• Contact email

  katy.hester@ncl.ac.uk

• Sponsor organisation

  The Newcastle upon Tyne Hospitals NHS Foundation Trust

• Research summary

  There is currently little patient information on bronchiectasis, a chronic lung disease with rising prevalence. We identified in previous work that patients and their families wanted more information, which could potentially improve their understanding and self-management.

  A novel, patient-driven information resource has been developed in the now complete BRIE study, using in-depth interviews and focus groups with patients and carers. During the BRIEF study, this information package will be evaluated and refined and the feasibility of carrying out a randomised controlled trial (RCT) to determine its effect on understanding and health outcomes will be assessed. Participants will complete questionnaires at 3 study visits over 3 months and will be invited to focus groups to discuss their experience.

  Funder: NIHR

  Study Intervention: Arm 1: Novel patient information resource
  Arm 2: Usual care

  Primary objective: To inform the decision of whether to proceed to the large RCT and whether any refinements to the design or conduct of that trial are warranted.

  Secondary objective: To evaluate and further refine the patient information resource and collect information on patient preferences.

  Primary outcome: The confirmation or otherwise that the study site will be able to identify, recruit and retain the required number of eligible participants. The acceptability of the intervention (as manifested through recruitment and retention levels), the feasibility and acceptability of the data collection tools (completion rates and quality of data) and clinical data to calculate the sample size for the full RCT. Production of protocols for the full trial.

  Secondary outcome: To modify and refine the patient information resource and its delivery based on quantitative and qualitative data.

  Number of study sites: ONE (Newcastle-upon-Tyne Hospitals NHS Trust)

  Study population/size: 60 Adults with bronchiectasis plus additional maximum of 10 carers who may have used the resource to take part solely in the focus groups about their experiences.

  Study duration: 28 months (patient is within the main study for 3 months)

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  14/NE/0119

• Date of REC Opinion

  8 May 2014

• REC opinion

  Further Information Favourable Opinion