- FIGURE 1
CONSORT flow diagram for the study. The participant re-entered in myCOPD was still excluded from analysis as 6 months had elapsed between baseline and post-baseline assessments.
- FIGURE 2
Participants’ profiles of using the app at least once per day over the trial period. Data shown here were available for 26 of the 29 participants; first day is defined as baseline visit. Each row in the figure corresponds to the profile of a participant where a coloured square means an activity, e.g. watched a video or reported symptom score, recorded in the app for that day.
- FIGURE 3
Mean change in COPD assessment test (CAT) score for each timepoint compared to baseline. Participants are included at each timepoint if a CAT score was recorded. For myCOPD there are 29 participants included at baseline, 25 at month 1 and 24 at month 2 and end of study (EOS). For usual care there are 31 participants included at baseline, 30 at month 1, 29 at month 2 and 30 at end of study.
- TABLE 1
Key baseline demographics of participants in study
Baseline characteristic Treatment Total myCOPD Standard care Subjects n 29 31 60 COPD severity Mild 7 (24.1) 7 (22.6) 14 (23.3) Moderate 22 (75.9) 24# (77.4)# 46# (76.7)# Age years 65.9±7.3 66.4±7.0 66.1±7.1 Years since COPD diagnosis 7.9±6.9 6.1±5.9 7.0±6.4 Gender Female 18 (62.1) 11 (35.5) 29 (48.3) Male 11 (37.9) 20 (64.5) 31 (51.7) Current smoker 7 (24.1) 9 (29.0) 16 (26.7) Years of smoking 39.0±11.0 38.6±12.5 38.8±11.7 ≥1 exacerbation (past 3 months) 11 (37.9) 3 (9.7) 14 (25.0) Treated with antibiotics 10 (34.5) 2 (6.5) 12 (20.0) Treated with steroids 8 (27.6) 3 (9.7) 11 (18.3) Requiring emergency department attendance 0 (0.0) 1 (3.2) 1 (1.7) Requiring hospitalisation 0 (0.0) 1 (3.2) 1 (1.7) Requiring intensive therapy unit admission 0 (0.0) 0 (0.0) 0 (0.0) Total duration of stay days 0.0±0.0 0.8±1.5 0.2±0.8 CAT 21.5±8.0) 19.8#±5.3# 20.6#±6.7# EQ5D 5L Index Score 0.6±0.3) 0.7 (0.2) 0.6 (0.3) EQ5D 5L VAS 61.9±20.6 63.3#±19.7# 62.6#±20.0# PAM 59.9±15.9) 69.0#±13.8)# 64.6#±15.4# PAM level 1 6 (20.7) 1 (3.2) 7 (11.7) 2 8 (27.6) 2 (6.5) 10 (16.7) 3 9 (31.0) 15# (48.4)# 24# (40.0)# 4 6 (20.7) 13 (41.9) 19 (31.7) SEAMS 32.8#±5.7# 33.8±4.9 33.3#±5.3# Individuals with ≥1 critical error – inhaler technique 21 (72.4) 18 (58.1) 39 (65.0) Average errors per device 1.1±1.3 1.0±1.1 1.0±1.2 Daily step count 4948.7±1667.6 9060.1±5135.1 7591.8±4611.1 Data are presented as n (%) or mean±sd, unless otherwise stated. The denominator for percentages is the number randomised into the study. Three participants with missing data have been included in this table; # denotes variables that were imputed as a result. CAT: COPD assessment test; EQ5D 5L: EuroQol 5 dimensions 5-level questionnaire; VAS: visual analogue scale; PAM: patient activation measurement; SEAMS: self-efficacy for appropriate medication use scale.
- TABLE 2
Treatment difference in COPD assessment test (CAT) score at 90 days for different definitions of adherence
Usage definitions Active users Adjusted treatment estimate 95% confidence interval Total usage Activated app 18 −1.63 −5.56–2.30 >30 days 12 −2.47 −8.46–3.53 ≥60 days 7 −4.28 −15.00–6.43 Sustained usage 50% weeks active 14 −2.13 −7.24–2.98 75% weeks active 12 −2.47 −8.46–3.53 90% first, 90% second 10 −2.93 −9.97–4.10 Analysis only includes the 54 participants who were at the final study visit. All participants in usual care are assumed not to have used the app under all usage definitions.
- TABLE 3
Results of all regression analysis and 90-day estimates for primary and secondary outcomes
Effectiveness outcomes 90-day change from baseline Regression sample size Adjusted group difference 95% confidence interval p-value myCOPD# Usual care¶ Primary outcomes CAT score −1.8 (5.76) 0.0 (5.54) 58 MD: −1.27 −4.47–1.92 0.435 ≥1 inhaler error −0.3 (0.70) 0.1 (0.71) 54 OR: 0.30 0.09–1.06 0.061 Average inhaler errors −0.3 (1.61) −0.1 (1.20) 54 IRR: 0.97 0.52–1.81 0.928 Secondary outcomes PAM score −0.7 (14.28) −3.5 (13.07) 58 MD: −0.98 −8.22–6.26 PAM level 0.1 (0.83) −0.3 (0.70) 54 OR: 1.65 0.46–5.85 SEAMS 1.0 (0.00) 0.0 (−3.00) 58 MD: 0.33 −2.22–2.87 EQ5D score 0.1 (0.23) 0.0 (0.18) 54 MD: −0.04 −0.12–0.05 EQ5D VAS 62.0 (21.35) 60.9 (19.92) 53 MD: 0.86 −9.46–11.18 Exacerbations 0.2 (1.28) 0.2 (0.72) 60 IRR: 2.55 1.17–5.54 Activity level (mean daily steps) 226.8 (5680.38) 11 915.9 (37 447.87) 13 MD: −2252.94 −10 433.77–5927.88 Smoking −0.0 (0.20) −0.0 (0.33) 53 OR: 0.76 0.07–7.89 Cessation 2 (6.9) 3 (9.7) 16 OR: 0.60 0.04–9.09 All regression models included adjustment for baseline values, COPD severity and centre. n in 90-day observed outcome is defined as participants who were at the final study visit. CAT: COPD assessment test; MD: mean difference; OR: odds ratio; IRR: incidence rate ratio; PAM: patient activation measurement; SEAMS: self-efficacy for appropriate medication use scale; EQ5D: EuroQol 5 dimensions; EQ5D VAS: EuroQol 5 dimensions visual analogue scale. #: n=24; ¶: n=30. Example interpretation: MD – A difference of −1.27 means after adjustment for baseline values, COPD severity and centre the mean CAT score was 1.27 lower in myCOPD. IRR – A difference of 0.97 means after adjustment for baseline values, COPD severity and centre the rate of average inhaler errors for myCOPD was 0.97 times the rate of average inhaler errors for usual care. OR – A difference of 0.30 means after adjustment, the odds of ≥1 inhaler error in myCOPD were 0.30 times the odds of ≥1 inhaler error in usual care.
- TABLE 4
Numbers of exacerbations, and treatment, at baseline and throughout the study
Timepoint Exacerbations Treatment Antibiotics Steroids Both None Treatment N n events N n events N n events N n events N n events Baseline myCOPD 11 12 3 3 1 2 7 7 0 0 Usual care 3 3 0 0 2 2 1 1 0 0 Post-baseline myCOPD 13 18 6 8 2 2 4 6 2 2 Usual care 8 11 2 2 1 1 6 6 1 2 A participant is counted in more than one treatment column if they had multiple exacerbations with different treatments.
Supplementary Materials
Supplementary Material
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Supplementary material 00460-2020.SUPPLEMENT
Related Data
