A randomised controlled trial of a complex intervention to manage breathlessness in pulmonary fibrosis
Management of breathlessness for people with pulmonary fibrosis
Enrolment, randomisation and blinding The HHTU will provide a web-based randomisation system within their electronic data capture system, REDCap Cloud (RCC). Participants will be randomised to receive the breathlessness intervention within 1 week of randomisation (fast-track) or to be placed on a waiting list for 8 weeks prior to receiving the intervention (wait-list group) in a 1:1 ratio using random permuted blocks stratified by site and mMRC (strong relationship between breathlessness severity and survival). Blinding of participants is not possible and where blinding of research nurses has been attempted before in a similar intervention study, the blind was broken in nearly 50% of cases by the participant during study assessments. However, the study statistician and the health economist undertaking analysis will be blinded to group allocation. Study intervention The breathlessness intervention will be delivered by a local clinician/therapist at participating sites trained by our study physiotherapist who is skilled in breathlessness management, thereby facilitating standardisation of content. The intervention is designed to be delivered by any suitable clinician/therapist (e.g. nurses, physiotherapists, or other suitably qualified clinicians). All of the clinicians will be trained in the breathlessness intervention components, and the tailoring of these to the participant. The training session (maximum 2 hours) will be conducted online and recorded on MS Teams. The recording and a copy of the presentation slides will be made available for all of the site clinicians delivering the intervention. All sites will be provided with the intervention resources: breathlessness intervention leaflet and the handheld fans for the training session. The intervention sessions consist of two one-hour face-to-face consultations and one phone consultation. These will be undertaken at 1-week intervals over a 3-week period with a trained clinician/therapist. The phone call consul
1. Males and females aged ≥50 years. This age cut-off is chosen to reduce the likelihood of including patients with nonfibrotic ILD 2. PF* diagnosed by multidisciplinary team (MDT) consensus in accordance with international guidelines 3. If on treatment for PF (with antifibrotic or immunomodulatory medication), on the same dosage for at least 1 month 4. mMRC (Modified Medical Research Council) breathlessness grades 3 or 4 despite optimal management* (i.e. stops for breath after walking about 100 yards or after a few minutes on level ground or is too breathless to leave the house or is breathless when dressing) 5. Resting oxygen saturation ≥90% on air/using usual oxygen prescription 6. Able to give informed consent * Specifically, the diagnosis of PF is confirmed if a patient has: 2.1. A diagnosis of idiopathic pulmonary fibrosis (IPF) OR 2.2. A diagnosis of non-IPF pulmonary fibrosis, with fibrosing lung disease (reticulation including evidence of traction bronchial dilatation and/or honeycombing) affecting more than 10% of lung volume (estimated) on CT scan
1. Significant comorbid cardiorespiratory disease other than PF considered by the PI to be the primary cause of breathlessness 2. Pulmonary rehabilitation: completed ≤ 3 months before study entry 3. Breathlessness clinic attendance: completed ≤ 3 months before study entry or to be started in the next 16 weeks 4. Acute exacerbation of PF within 3 months 5. Unwilling or unable to give informed consent or complete study measures 6. Australian-modified Karnofsky Performance Status of at least 60 (60=Considerable assistance and frequent medical care required)