Specialty: Respiratory disorders, Primary sub-specialty: Respiratory disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosed with CF and within CF registry 2. Aged 16 years and above 3. Taking inhaled mucolytics or antibiotics via a chipped nebuliser (e.g. eTrack or I-Neb or able and willing to take via eTrack or I-Neb)
Exclusion criteria
Exclusion criteria: 1. Post-lung transplant 2. People on the active lung transplant list 3. Patients receiving palliative care, with palliative intent, for whom trial participation could be a burden 4. Participants who lack capacity to give informed consent 5) Participants using dry powder devices to take antibiotics or mucolytics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of pulmonary exacerbations of cystic fibrosis is measured using the modified Fuchs Criteria at baseline and 5 (+/- 1) months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Generic health status is measured using the EQ5D5L at baseline and 5 (+/- 1) months 2. Assessment of patient knowledge, skill, and confidence for self-management is measured using the Patient Activation Measure -13 at baseline and 5 (+/- 1) months 3. Life chaos is measured using the Confusion, Hubbub And Order Scale -6 at baseline and at 5 +/- 1 months 4. Habit-based behaviour patterns are measured using the Self-Reported Behavioural Automaticity Index at baseline and 5 (+/- 1) months 5. Disease specific health-related quality of life is measured using the Cystic Fibrosis Questionnaire-Revised at baseline and 5 (+/- 1) months 6. Depressive disorder severity is measured using the Patient Health Questionnaire depression scale -8 at baseline and 5 (+/- 1) months 7. Medication adherence is measured using the Medication Adherence Data -3 at baseline and 5 (+/- 1) months 8. Anxiety severity is measured using the General Anxiety Disorder -7 at baseline and 5 (+/- 1) months 9. Perceived necessities and concerns for nebuliser treatment are measured using the Capability Opportunity Motivation–Beliefs about Medicines Questionnaire at baseline and 5 (+/- 1) months 10. Resource use data is collected using the resource use form developed for the study at 5 (+/- 1) months 11. Acceptability of the intervention is determined through qualitative interviews with patients and members of the multidisciplinary CF team at 5 (+/- 1) months 12. Condition severity is measured using FEV1/FVC at routine clinic visits from baseline to study end | — |
Countries
England, United Kingdom