Table 2

Baseline demographic and clinical characteristics, by randomised treatment group

Usual careIntervention
Female, n (%)303154 (50.8)304156 (51.3)
Age, years30330.3±10.830431.1±10.6
Prescribed number of daily nebuliser doses, n (%)
 129860 (20.1)30385 (28.1)
 229849 (16.4)30339 (12.9)
 329893 (31.2)30391 (30.0)
 429838 (12.8)30332 (10.6)
 529838 (12.8)3033 (10.9)
 62989 (3.0)30310 (3.3)
 ≥729811 (3.7)30313 (4.3)
Socioeconomic deprivation quintiles, n (%)
 1 (least deprived)30251 (16.9)30250 (16.6)
 230271 (23.5)30259 (19.5)
 330266 (21.9)30263 (20.9)
 430267 (22.2)30263 (20.9)
 5 (most deprived)30247 (15.6)30267 (22.2)
Pseudomonas aeruginosa status, n (%)‡
 Chronic299175 (58.5)304174 (57.2)
 Non-chronic299124 (41.5)304130 (42.8)
 Previous year’s intravenous treatment, days30327.7±33.030424.2±27.9
Secondary outcomes: baseline values
 Objectively measured effective adherence (weekly), %§29545.5±34.129354.1±33.0
 FEV1 % predicted30258.3±22.630460.7±23.5
 Body mass index, kg/m2 30322.5±4.230422.7±4.2
Patient-reported outcomes: baseline values
CFQ-R (quality of life):
 Body image30266.1±29.330465.6±28.0
 Treatment burden30251.8±20.230454.4±19.8
BMQ-Specific (beliefs about medication):
 SRBAI (habit strength for using nebuliser)30012.0±4.730312.1±5.0
 Perceptions of treatment adherence (three-item scale)2749.9±3.428010.2±3.4
 Effort of nebuliser treatments (one item)3003.1±1.23023.1±1.3
 Subjective adherence question
 – % (self-report estimate of adherence)
 CHAOS-6 (life chaos or routine)3009.5±2.93039.5±2.9
 PAM-13 (health style assessment)30265.3±13.330465.8±14.5
 EQ-5D-5L (generic health status)3000.84±0.163030.85±0.15
 PHQ-8 (depression)3016.4±5.13046.4±5.2
 GAD-7 (anxiety)3024.7±4.73024.6±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.