BRonchiectasis Information and Education Feasibility study
| ISRCTN | ISRCTN84229105 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84229105 |
| Secondary identifying numbers | 16655 |
- Submission date
- 25/07/2014
- Registration date
- 25/07/2014
- Last edited
- 16/04/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
There is currently little patient information about bronchiectasis, a long-term lung disease. We found in a previous study that patients and their families wanted more information, which could help to improve their understanding and self-management. A new information package has been developed by healthcare professionals working with patients and their families. During this study, this information package will be evaluated and refined and the feasibility of carrying out a clinical study to find out its effect on understanding and health outcomes will be assessed.
Who can participate?
Adults who have a diagnosis of bronchiectasis and attend a specialist or general clinic at the Newcastle upon Tyne Hospitals NHS Trust, UK.
What does the study involve?
Those who consent to take part in the study will be randomly assigned to either receive the new patient information resource or to receive usual care. Those who receive the information package will receive a booklet and the login details for the website. They will be able to use this as much as they wish for the 3 months that they take part in the study. Should they have family members/a spouse who is interested we would also encourage them to use the resource. Participants will have three study visits over 3 months: the initial visit, a follow-up visit at 2-4 weeks (with this as an optional telephone visit rather than in person), and a final end of study visit at 3 months. Each visit should last less than 1 hour and will involve completion of quality of life, symptom, knowledge and evaluation questionnaires. At visits 1 and 3 lung function tests will also be performed. Each month participants will be asked to complete a short postal questionnaire about their symptoms and use of information. Some participants will also be invited to focus groups to discuss their experience at the end of the study. In addition, up to 10 additional carers will be invited to these groups if they have used the information pack and wish to give their views. Those who are allocated to the usual care group will be offered use of the information package once they have completed the study.
What are the possible benefits and risks of participating?
We cannot promise the study will help you. The information we get from this study may help improve the understanding of patientsÂ’ needs, and help us develop better information resources for patients with bronchiectasis. There are no likely risks to taking part in this study. Participants will be asked to attend three study visits in total, each lasting less than 1 hour, over the 3-month period of their involvement in the study. Also, patients will be given the option of completing the 2nd (middle) visit over the telephone to reduce the burden of travel should they wish. Some participants will also be invited to take part in a focus group but this will be entirely optional.
Where is the study run from?
The Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
The study started in June 2014 and is expected to end in September 2016. Participants are involved for a 3-month period only.
Who is funding the study?
The National Institute for Health Research (NIHR), UK
Who is the main contact?
Dr Katy Hester
Katy.hester@ncl.ac.uk
Contact information
Scientific
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
| katy.hester@ncl.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | BRonchiectasis Information and Education: Feasibility study and evaluation of a novel resource |
| Study acronym | BRIEF |
| Study objectives | This is a feasibility study to determine if it would be possible to conduct a large trial to assess whether provision of a patient-focussed information and education resource can improve patient understanding, self-management and health outcomes in bronchiectasis. |
| Ethics approval(s) | Sunderland REC, 27/05/2014, ref. 14/NE/0119 |
| Health condition(s) or problem(s) studied | Topic: Respiratory disorders; Subtopic: Respiratory (all Subtopics); Disease: Respiratory |
| Intervention | 30 participants will be recruited to both the intervention and control groups. 10 additional carer participants will be recruited to the focus groups at the end of recruitment Patient information package: a novel information resource in the form of a website (or PDF) and a booklet will be used as the intervention Study Entry : Single Randomisation only |
| Intervention type | Other |
| Primary outcome measure | Feasibility of conducting a definitive RCT; Timepoint(s): End of study |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 02/06/2014 |
| Completion date | 30/09/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 70; UK Sample Size: 70 |
| Total final enrolment | 62 |
| Key inclusion criteria | 1. Participant has capacity to provide written informed consent 2. Aged 18 years or over 3. Clinical and radiological diagnosis of bronchiectasis 4. English speaking 5. Internet access (direct personal access or access via family/friend/local library etc) |
| Key exclusion criteria | 1. Cognitive impairment 2. Non-English speaking 3. Complete lack of internet access 4. Aged <18 years 5. Participation in the preceding BRIE study |
| Date of first enrolment | 02/06/2014 |
| Date of final enrolment | 30/09/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
NE7 7DN
United Kingdom
Sponsor information
Hospital/treatment centre
Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
England
United Kingdom
"ROR" |
https://ror.org/05p40t847 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 23/04/2016 | Yes | No | |
| Results article | results | 15/04/2020 | 16/04/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
16/04/2020: Publication reference and total final enrolment number added.
11/03/2019: Internal review.
11/01/2019: No publications found, verifying study status with principal investigator.
04/05/2016: Publication reference added.
