Chronic obstructive pulmonary disease Respiratory
Conditions
Interventions
This is a feasibility study involving mixed methods and consisting of a pilot Randomised Controlled Trial (RCT) and process evaluation. A feasibility study is a small study that acts like a test run f
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
35 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. Stable COPD (no exacerbation needing antibiotics or steroids in the preceding past 4 weeks) 2. Aged 35 years and over 3. MRC breathlessness scale > = 3 (“walks slower than contemporaries on level ground because of breathlessness, or has to stop for breath when walking at own pace”) 4. Declined Pulmonary Rehabilitation (rehab) 5. Unable to attend rehab or discontinued rehab following their first or second session
Exclusion criteria
Exclusion criteria: 1. History of spontaneous pneumothorax 2. Incomplete recovery from a traumatic pneumothorax 3. Asthma 4. Perforated eardrum 5. Unstable angina 6. Ventricular dysrhythmias 7. Cerebral event or myocardial infarction within the last two months 8. More than two sessions of PR within the last year 9. Oral antibiotics or steroids for exacerbation within the last four weeks 10. Pregnancy
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary feasibility outcomes: 1. Retention (proportion of participants randomised who enrol and who complete the study with a valid PiMax outcome at 9-months post-randomisation) 2. Reasons for dropout from intervention or trial (qualitative data) measured throughout the study period 3. Data completion rates from clinical and patient-reported outcome measures measured at the end of the study period 4. Adherence with SIMT measured at weeks 1-8 and week 38 5. Feasibility of accessing health utilisation outcome data from electronic health records , evaluated at the end of the study period 6. Acceptability of SIMT measured using questionnaire at baseline, week 8 and 9 months. 7. Feasibility of delivering the intervention: visits/sessions cancelled, recording of first two sessions delivered by each HCP to evaluate fidelity with support for SIMT (motivational interview principles and behaviour change techniques), collated at the end of the study period. 8. Progression to full-scale RCT using a Red (not recommended), Amber (recommended with modifications), Green (recommended) system, with the following criteria: Recruitment rate: Red: =0.50 and < 1.1 participants per centre per month Green: =1.1 participants per centre per month Retention proportion at 9 months: Red: <50% randomised participants Amber: 50-79% randomised participants Green: =80% randomised participants Clinical outcomes – to be used as comparative outcome measures in the definitive trial and potentially inform sample size for the definitive trial: 1. Maximum Inspiratory Pressure (PiMax) measured in centimetres of water (cmH2O) from residual volume (RV) and functional residual capacity (FRC) using the POWERbreathe KH2 at baseline, 8 weeks and 9 months 2. Inspiratory flow measured from RV and FRC in litres per second (l/s) using the POWERbreathe KH2 at baseline, 8 weeks and 9 months 3. Disease-specific health status assessed using the validated, self-reported, 8-item COPD Assessment Test (CAT) questionnai | — |
Countries
England, United Kingdom
Contacts
Public ContactSarah Wilkinson
Outcome results
None listed