None listed
Conditions
Brief summary
Although once regarded as an ‘orphan disease’, BE remains a contributor to chronic respiratory morbidity and mortality in both children and adults in both low and high-income countries, in particular Indigenous people of high-income countries. Postnatally, lung growth is maximised in the first 7-yrs of life. While low birth weight impacts on future lung health, there is increasing evidence that early life events such as acute lung respiratory infections (ALRI) can reduce future lung function trajectories, and increase BE risk. In early childhood, severe (hospitalised) and repeated ALRI are independent risk factors for future chronic lung diseases, such as BE and non-smoking related COPD which are prevalent amongst Indigenous populations. Interventions to reduce ALRI during infancy and early childhood are important and needed for future lung health i.e. preserve lung function and improve quality of life (QoL). Our double blind RCT is designed to answer our primary question: To determine if the routine use of a personalised written BAMP (compared to standard care) improves clinical outcomes [improves cough-specific QoL (8 items) (PC-QoL -8) and reduces non-scheduled doctor visits]. We aim to enrol 198 (children less than 19 years old) from Royal Darwin Hospital and Lady Cilento Hospital. Participants will be seen clinically at enrolment and followed up monthly with phone calls for 12 months. To date, there are no such published studies in children or adults using BAMP with BE. It is not surprising that BAMP is not routinely used even in tertiary centres. If effective, this RCT will lead to a change in routine clinical practice in children with BE. This will be of great importance, particularly to those living in remote Indigenous communities, where specialist respiratory services are limited. The results will provide evidence for/against the use of BAMP when managing Indigenous and non-Indigenous children with BE.
Interventions
Children will been seen by their paediatric respiratory physician in the outpatient department at Royal Darwin Hospital or Lady Cilento Hospital during a routine clinical visit. The consultation will range from 30-45 minutes. The respiratory physician will write an individualised written Bronchiectasis Action Management plan (BAMP) for each child. The BAMP consists of several key points.
1. Details of their bronchiectasis: type and which lobes are involved
2. A list of what the child should do
Children will been seen by their paediatric respiratory physician in the outpatient department at Royal Darwin Hospital or Lady Cilento Hospital during a routine clinical visit. The consultation will range from 30-45 minutes. The respiratory physician will write an individualised written Bronchiectasis Action Management plan (BAMP) for each child. The BAMP consists of several key points. 1. Details of their bronchiectasis: type and which lobes are involved 2. A list of what the child should do on a daily basis e.g. type of medication and airway clearance technique 3. What to do when there is a flare up 4. Indications when to see a doctor 5. When to obtain their influenza vaccine. In the intervention arm, carers will receive a copy of the letter written to the family/s general practitioner. This letter outlines the relevant medical history and treatment, management and follow-up required. In addition, the carers will receive a copy of the BAMP that is current for 12 months. A Research Nurse will deliver face to face education to carers at enrolment how to use the BAMP.
Sponsors
Menzies School of Health Research
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Children aged <19-yrs with chronic suppurative lung disease or bronchiectasis 2. At least 2 or more non-scheduled doctor visits or exacerbations in the previous 18 months 3. Do not currently have a BAMP
Exclusion criteria
1. Cystic fibrosis 2. Children who have an existing written plan 3. Inability to follow-up due to no access to a landline or mobile phone
Outcome results
None listed