Background
Methods
Design
Participants
Consent and randomisation
The complex intervention
Summary of the intervention development process
Sample size
Outcomes
Secondary outcomes | |
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Body Mass Index (BMI). | |
Forced expiratory volume in 1 s (FEV1): standardised spirometry as a measure of condition severity [100]. | |
EuroQol EQ-5D-5 L: generic health status measure for health economic analysis [101]. | |
The Patient Activation Measure (PAM-13): assessment of patient knowledge, skill, and confidence for self-management [102]. Elements of the PAM-13 map to logic model constructs #29 and #30. | |
Confusion, Hubbub, and Order Scale (CHAOS 6-item): measure of life chaos [103]. Elements of the CHAOS-6 map to logic model construct #32. | |
Medication Adherence Data-3 items (MAD-3). Bespoke questionnaire adapted from the Medication Adherence Reporting Scale [104]: 1. I forget to take my nebuliser treatment (Always/Often/Sometimes/Rarely/Never) 2. I take fewer nebuliser treatments than my doctor recommends (Always/Often/ Sometimes/Rarely/Never) 3. I decide to skip one or more of my nebuliser treatments (Always/Often/Sometimes/Rarely/Never) Maps to logic model construct #28. | |
Self-Report Behavioural Automaticity Index (SRBAI) [105]. Maps to logic model construct #31. | |
Cystic Fibrosis Questionnaire-Revised (CFQ-R): disease specific health-related quality of life instrument [106]. | |
The Patient Health Questionnaire depression scale (PHQ-8): severity measure for depressive disorders [107]. | |
The General Anxiety Disorder 7-item anxiety scale (GAD-7): severity measure for anxiety [108]; | |
The Capability Opportunity Motivation Behaviour Beliefs Questionnaire (COM- BMQ), incorporating the validated self-report Beliefs about Medicines Questionnaire - specific (Nebuliser adherence) (BMQ 21-item) [109], customised by the team to identify perceived necessities and concerns for nebuliser treatment. Elements of the COM-BMQ map to logic model constructs #7, #29 and#33. | |
Project-specific items on belief, intention and confidence | |
Subjective adherence single question: self-report estimate of adherence as a percentage. Maps to logic model construct #28. | |
Self-reported problems: identification of capability and opportunity barriers to nebuliser adherence. Maps to logic model construct #33. | |
Concomitant medications: bespoke instrument, designed for this research project. | |
Resource use form (inpatient IV days; routine clinic visits; unscheduled outpatient contacts; unscheduled inpatient stays). | |
Prescription: a monthly prescription check to both check for data transfer to CFHealthHub and review for an indication that the prescription has changed | |
Objective Adherence to prescribed medication | |
Any treatment with IV antibiotics |
Data analysis
Approach taken to modifying research procedures
Patient and public involvement
Ethical approval
Results
Recruitment
Participant characteristics
Intervention | Control | Overall | |
---|---|---|---|
Age | |||
n | 33 | 31 | 64 |
Mean (SD) | 31.6 (13.3) | 27.8 (8.9) | 29.7 (11.5) |
Median (IQR) | 28 (21,37) | 26 (20,34) | 27 (21,36) |
Sex | |||
Male | 18 (55%) | 18 (58%) | 36 (56%) |
Female | 15 (45%) | 13 (42%) | 28 (44%) |
Socioeconomic Status | |||
Most deprived | 6 (18%) | 1 (3%) | 7 (11%) |
High deprivation | 4 (12%) | 7 (23%) | 11 (17%) |
Average | 8 (24%) | 8 (26%) | 16 (25%) |
Low deprivation | 6 (18%) | 9 (29%) | 15 (23%) |
Least deprived | 9 (27%) | 6 (19%) | 15 (23%) |
FEV1% Predicted | |||
n | 33 | 31 | 64 |
Mean (SD) | 53.4 (19.4) | 61.4 (22.7) | 57.3 (21.3) |
Median (IQR) | 49.2 (39.4,61.9) | 53.4 (43,80) | 49.6 (41.9,76.7) |
Retention
Quality of primary clinical outcome data
Other key clinical outcomes
Intervention | Control | ||||||
---|---|---|---|---|---|---|---|
n | Median (IQR) | n | Median (IQR) | IRR | 95% CI | ||
Number of exacerbations treated with IV antibiotics with at least 1 Fuchs’ criteria in a 6 month period (primary outcome definition) | Unadjusted | 32 | 1 (0, 2) | 28 | 0.5 (0, 2) | 1.22 | (0.69,2.21) |
Adjusteda | 1.12 | (0.66,1.94) | |||||
n | Mean (SD) | n | Mean (SD) | Mean Diff | 95% CI | ||
FEV1 percent predicted | Unadjusted | 30 | 54.2 (21.1) | 27 | 59 (23.9) | −4.8 | (−17,7.1) |
Adjustedb | 5 | (−2,12) |