Idiopathic pulmonary fibrosis Respiratory Other interstitial pulmonary diseases with fibrosis
Conditions
Interventions
Participants will be randomised in a 1:1 ratio using random permuted blocks to receive the breathlessness treatment straight away or be placed on a waiting list to start the treatment 8 weeks later.
Sponsors
Hull and East Yorkshire Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females aged =50 years. This age cut-off is chosen because IPF is very rare under 50 years of age making an alternative diagnosis likely 2. IPF diagnosed by multidisciplinary team (MDT) consensus in accordance with international guidelines 3. mMRC dyspnoea grades 3 or 4 despite optimal management 4. Oxygen saturation =90% on air/using usual oxygen prescription 5. Able to give informed consent
Exclusion criteria
Exclusion criteria: 1. Significant comorbid cardiorespiratory disease other than IPF considered by the principal investigator to be the primary cause of breathlessness 2. Pulmonary rehabilitation: completed < = 3 months previously 3. Breathlessness clinic attendance: completed < = 3 months previously 4. Unwilling or unable to consent or complete study measures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary aim of this trial is to establish the feasibility of a definitive trial. Specific study objectives will address uncertainties in the following 5 areas: 1. Recruitment: the eligibility:consent ratio, recruitment rate and participant retention rate to inform the number of sites needed to enrol sufficient participants within an acceptable timeline, and the acceptability of recruitment and randomisation processes from the patients’ perspective 2. Intervention: the acceptability and fidelity of the intervention is assessed by measuring adherence in delivery and uptake, and via patient and carer interviews. This will include documenting aspects of breathlessness interventions used in the control arm provided ad hoc e.g. breathing techniques, use of the hand-held fan etc 3. Data quality: the amount and pattern of missing data for study measures. Data variability across the range of outcome measures will also be assessed. These findings will inform the choice of primary and secondary outcomes for a definitive trial 4. Outcome: assess the best primary outcome and agree other study measures for the definitive trial by identifying i) patient views about relevance, importance and acceptability of questionnaires or other measures (qualitative interview data), ii) data completion (objective 3), iii) data variability for potential primary outcome measures to inform sample size calculation for the definitive trial 5. Health economic assessment: the feasibility of undertaking a cost-effectiveness analysis in the definitive trial assessed by collecting data on health service utilisation (e.g. out-patient clinic attendance, emergency department attendance, hospital or hospice admission, appointment in primary care etc), health-related quality of life (EQ-5D-5L) and well-being (ICECAP-SCM) | — |
Secondary
| Measure | Time frame |
|---|---|
| The following study measures will be undertaken to assess acceptability and identify the most appropriate primary outcome measure for the substantive trial: Clinical outcomes: 1. Breathlessness, assessed at baseline, 4, 8, 12 and 16 weeks using: 1.1. Breathlessness mastery assessed by the breathlessness mastery domain of the Chronic Respiratory Disease Questionnaire (CRQ) 1.2. Numerical rating scales (NRS, scored 0-10 where lower scores represent a lower symptom burden) to assess the following aspects of breathlessness over the past 24 hours: average breathlessness, worst breathlessness, distress caused by breathlessness, coping with breathlessness 2. Quality of life, assessed at baseline, 4, 8, 12 and 16 weeks using: 2.1. Disease specific: St George's Respiratory Questionnaire for patients with IPF (SGRQ-I) 2.2. Generic: EQ-5D-5L 2.3. Well-being: ICECAP-SCM 3. Mood, assessed at baseline, 4, 8, 12 and 16 weeks using: 3.1. The hospital anxiety and depression scale (HADS) 4. Physical activity, functional status and exercise capacity, assessed at at baseline, 4, 8, 12 and 16 weeks: 4.1. Functional status, assessed using the Australian-modified Karnofsky Performance Status 4.2. Exercise capacity, assessed using incremental shuttle walk tests (ISWT) performed in accordance with European Respiratory Society/American Thoracic Society technical standards. Two incremental shuttle walking tests will be undertaken at baseline (one when the activity monitor is fitted, and the second on its removal) with the second taken as the baseline value to eliminate the known learning effect 4.3. Physical activity, measured objectively during normal daily life by asking participants to wear an accelerometer for a period of 7 days. Data on step counts, physical activity duration and physical activity levels will be evaluated. The outcome measure will be average daily steps | — |
Countries
England, United Kingdom
Outcome results
None listed