Management of breathlessness for people with pulmonary fibrosis Respiratory
Conditions
Interventions
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
Sponsors
Hull University Teaching Hospitals NHS Trust
Eligibility
Sex/Gender
All
Age
50 Years to 110 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Worst Breathlessness in the past 24 hours measured using the patient reported NRS worst Breathlessness score assessed at 4 week follow-up (Primary time point). NRS worse Breathlessness score will also be collected at the 8 week, 12 week and 16 week follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. NRS Coping with Breathlessness in the past 24 hours measured using the patient reported NRS Coping with Breathlessness score. This will be collected at the 4 week, 8 week, 12 week and 16 week follow-up 2. NRS Distress due to breathlessness in the past 24 hours measured using the patient reported NRS Distress due to breathlessness score. This will be collected at the 4 week, 8 week, 12 week and 16 week follow-up 3. Functional capacity measurement using the Australia-modified Karnofsky Performance scale (AKPS). This will be collected at will be collected at the 4 week, 8 week, 12 week and 16 week follow-up 4. Health status and quality of life assessed using the patient reported EQ-5D-5L (EQ-5D scale and EQ-VAS). This will be collected at the 4 week, 8 week, 12 week and 16 week follow-up. It will also be used for the health economic evaluation 5. Health service utilisation collected using a bespoke version of the Client Service Reciept Inventory (CSRI) 37). This will be collected at the 4 week, 8 week, 12 week and 16 week follow-up | — |
Countries
England, Northern Ireland, Scotland, United Kingdom
Contacts
Public ContactGrant Constable
Outcome results
None listed