Baseline demographic and clinical characteristics, by randomised treatment group
| Usual care | Intervention | |||
| N* | Mean±SD† | N* | Mean±SD† | |
| Female, n (%) | 303 | 154 (50.8) | 304 | 156 (51.3) |
| Age, years | 303 | 30.3±10.8 | 304 | 31.1±10.6 |
| Prescribed number of daily nebuliser doses, n (%) | ||||
| 1 | 298 | 60 (20.1) | 303 | 85 (28.1) |
| 2 | 298 | 49 (16.4) | 303 | 39 (12.9) |
| 3 | 298 | 93 (31.2) | 303 | 91 (30.0) |
| 4 | 298 | 38 (12.8) | 303 | 32 (10.6) |
| 5 | 298 | 38 (12.8) | 303 | 3 (10.9) |
| 6 | 298 | 9 (3.0) | 303 | 10 (3.3) |
| ≥7 | 298 | 11 (3.7) | 303 | 13 (4.3) |
| Socioeconomic deprivation quintiles, n (%) | ||||
| 1 (least deprived) | 302 | 51 (16.9) | 302 | 50 (16.6) |
| 2 | 302 | 71 (23.5) | 302 | 59 (19.5) |
| 3 | 302 | 66 (21.9) | 302 | 63 (20.9) |
| 4 | 302 | 67 (22.2) | 302 | 63 (20.9) |
| 5 (most deprived) | 302 | 47 (15.6) | 302 | 67 (22.2) |
| Pseudomonas aeruginosa status, n (%)‡ | ||||
| Chronic | 299 | 175 (58.5) | 304 | 174 (57.2) |
| Non-chronic | 299 | 124 (41.5) | 304 | 130 (42.8) |
| Previous year’s intravenous treatment, days | 303 | 27.7±33.0 | 304 | 24.2±27.9 |
| Secondary outcomes: baseline values | ||||
| Objectively measured effective adherence (weekly), %§ | 295 | 45.5±34.1 | 293 | 54.1±33.0 |
| FEV1 % predicted | 302 | 58.3±22.6 | 304 | 60.7±23.5 |
| Body mass index, kg/m2 | 303 | 22.5±4.2 | 304 | 22.7±4.2 |
| Patient-reported outcomes: baseline values | ||||
| CFQ-R (quality of life): | ||||
| Physical | 302 | 53.0±30.2 | 304 | 54.3±30.6 |
| Emotional | 302 | 66.2±24.1 | 304 | 66.5±21.6 |
| Social | 302 | 60.9±20.9 | 304 | 61.9±20.0 |
| Eating | 302 | 80.5±24.3 | 304 | 82.1±22.5 |
| Body image | 302 | 66.1±29.3 | 304 | 65.6±28.0 |
| Treatment burden | 302 | 51.8±20.2 | 304 | 54.4±19.8 |
| Respiratory | 302 | 56.6±21.9 | 304 | 58.2±22.1 |
| Digestion | 302 | 81.1±19.4 | 304 | 79.9±21.5 |
| BMQ-Specific (beliefs about medication): | ||||
| Concerns | 301 | 2.1±0.5 | 304 | 2.1±0.6 |
| Necessities | 301 | 3.6±0.8 | 304 | 3.6±0.7 |
| SRBAI (habit strength for using nebuliser) | 300 | 12.0±4.7 | 303 | 12.1±5.0 |
| Perceptions of treatment adherence (three-item scale) | 274 | 9.9±3.4 | 280 | 10.2±3.4 |
| Effort of nebuliser treatments (one item) | 300 | 3.1±1.2 | 302 | 3.1±1.3 |
| Subjective adherence question – % (self-report estimate of adherence) | 298 | 69.0±30.8 | 300 | 69.9±31.0 |
| CHAOS-6 (life chaos or routine) | 300 | 9.5±2.9 | 303 | 9.5±2.9 |
| PAM-13 (health style assessment) | 302 | 65.3±13.3 | 304 | 65.8±14.5 |
| EQ-5D-5L (generic health status) | 300 | 0.84±0.16 | 303 | 0.85±0.15 |
| PHQ-8 (depression) | 301 | 6.4±5.1 | 304 | 6.4±5.2 |
| GAD-7 (anxiety) | 302 | 4.7±4.7 | 302 | 4.6±4.9 |
Full details and references for all patient-reported outcomes are available in the SAP (provided in online supplemental material).
*There were 608 participants randomised but one participant randomised to the intervention arm withdrew on the day of consent prior to baseline data collection, giving a maximum n=607 for baseline summaries.
†Unless otherwise stated.
‡Consensus definition.
§Weekly objectively measured effective adherence (sum of doses taken/sum of doses prescribed).
¶All patient-reported outcomes based on points, unless otherwise stated. For direction of positive effect and possible range, see table 3.
BMQ, Beliefs About Medicines Questionnaire; CHAOS-6, Confusion, Hubbub and Order six-item Scale; EQ-5D-5L, EuroQol 5-dimension and 5-level; GAD-7, Generalised Anxiety Disorder seven-item scale; PAM-13, Patient Activation 13-item Measure; PHQ-8, Patient Health Questionnaire eight-item depression scale; SAP, statistical analysis plan; SRBAI, Self-Report Behavioural Automaticity Index.