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Evidence generation for the clinical impact of myCOPD in patients with mild, moderate and newly diagnosed COPD: a randomised controlled trial

Michael G. Crooks, Jack Elkes, William Storrar, Kay Roy, Mal North, Alison Blythin, Alastair Watson, Victoria Cornelius, Tom M.A. Wilkinson
ERJ Open Research 2020 6: 00460-2020; DOI: 10.1183/23120541.00460-2020
Michael G. Crooks
1Hull York Medical School, Hull, UK
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  • For correspondence: Michael.crooks@hey.nhs.uk
Jack Elkes
2Imperial College London, London, UK
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William Storrar
3Hampshire Hospitals NHS Foundation Trust – Basingstoke Hospital, Basingstoke, UK
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Kay Roy
4West Hertfordshire Hospital NHS Trust – Hemel Hempstead Hospital, Hemel Hempstead, UK
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Mal North
5mymhealth Limited, Bournemouth, UK
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Alison Blythin
5mymhealth Limited, Bournemouth, UK
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Alastair Watson
6University of Southampton Faculty of Medicine, Southampton, UK
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Victoria Cornelius
2Imperial College London, London, UK
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Tom M.A. Wilkinson
5mymhealth Limited, Bournemouth, UK
6University of Southampton Faculty of Medicine, Southampton, UK
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Figures

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  • FIGURE 1
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    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
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    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
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    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.

Tables

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  • TABLE 1

    Key baseline demographics of participants in study

    Baseline characteristicTreatmentTotal
    myCOPDStandard care
    Subjects n293160
    COPD severity
     Mild7 (24.1)7 (22.6)14 (23.3)
     Moderate22 (75.9)24# (77.4)#46# (76.7)#
    Age years65.9±7.366.4±7.066.1±7.1
    Years since COPD diagnosis7.9±6.96.1±5.97.0±6.4
    Gender
     Female18 (62.1)11 (35.5)29 (48.3)
     Male11 (37.9)20 (64.5)31 (51.7)
    Current smoker7 (24.1)9 (29.0)16 (26.7)
    Years of smoking39.0±11.038.6±12.538.8±11.7
    ≥1 exacerbation (past 3 months)11 (37.9)3 (9.7)14 (25.0)
     Treated with antibiotics10 (34.5)2 (6.5)12 (20.0)
     Treated with steroids8 (27.6)3 (9.7)11 (18.3)
     Requiring emergency department attendance0 (0.0)1 (3.2)1 (1.7)
     Requiring hospitalisation0 (0.0)1 (3.2)1 (1.7)
     Requiring intensive therapy unit admission0 (0.0)0 (0.0)0 (0.0)
     Total duration of stay days0.0±0.00.8±1.50.2±0.8
    CAT21.5±8.0)19.8#±5.3#20.6#±6.7#
    EQ5D 5L Index Score0.6±0.3)0.7 (0.2)0.6 (0.3)
    EQ5D 5L VAS61.9±20.663.3#±19.7#62.6#±20.0#
    PAM59.9±15.9)69.0#±13.8)#64.6#±15.4#
    PAM level
     16 (20.7)1 (3.2)7 (11.7)
     28 (27.6)2 (6.5)10 (16.7)
     39 (31.0)15# (48.4)#24# (40.0)#
     46 (20.7)13 (41.9)19 (31.7)
    SEAMS32.8#±5.7#33.8±4.933.3#±5.3#
    Individuals with ≥1 critical error – inhaler technique21 (72.4)18 (58.1)39 (65.0)
    Average errors per device1.1±1.31.0±1.11.0±1.2
    Daily step count4948.7±1667.69060.1±5135.17591.8±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 definitionsActive usersAdjusted treatment estimate95% confidence interval
      Total usageActivated app18−1.63−5.56–2.30
      >30 days12−2.47−8.46–3.53
      ≥60 days7−4.28−15.00–6.43
      Sustained usage50% weeks active14−2.13−7.24–2.98
      75% weeks active12−2.47−8.46–3.53
      90% first, 90% second10−2.93−9.97–4.10

      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 outcomes90-day change from baselineRegression sample sizeAdjusted group difference95% confidence intervalp-value
        myCOPD#Usual care¶
        Primary outcomes
         CAT score−1.8 (5.76)0.0 (5.54)58MD: −1.27−4.47–1.920.435
         ≥1 inhaler error−0.3 (0.70)0.1 (0.71)54OR: 0.300.09–1.060.061
         Average inhaler errors−0.3 (1.61)−0.1 (1.20)54IRR: 0.970.52–1.810.928
        Secondary outcomes
         PAM score−0.7 (14.28)−3.5 (13.07)58MD: −0.98−8.22–6.26
         PAM level0.1 (0.83)−0.3 (0.70)54OR: 1.650.46–5.85
         SEAMS1.0 (0.00)0.0 (−3.00)58MD: 0.33−2.22–2.87
         EQ5D score0.1 (0.23)0.0 (0.18)54MD: −0.04−0.12–0.05
         EQ5D VAS62.0 (21.35)60.9 (19.92)53MD: 0.86−9.46–11.18
         Exacerbations0.2 (1.28)0.2 (0.72)60IRR: 2.551.17–5.54
         Activity level (mean daily steps)226.8 (5680.38)11 915.9 (37 447.87)13MD: −2252.94−10 433.77–5927.88
         Smoking−0.0 (0.20)−0.0 (0.33)53OR: 0.760.07–7.89
         Cessation2 (6.9)3 (9.7)16OR: 0.600.04–9.09

        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

          TimepointExacerbationsTreatment
          AntibioticsSteroidsBothNone
          TreatmentNn eventsNn eventsNn eventsNn eventsNn events
          Baseline
           myCOPD111233127700
           Usual care3300221100
          Post-baseline
           myCOPD131868224622
           Usual care81122116612

          A participant is counted in more than one treatment column if they had multiple exacerbations with different treatments.

          Supplementary Materials

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            Supplementary material 00460-2020.SUPPLEMENT

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          Evidence generation for the clinical impact of myCOPD in patients with mild, moderate and newly diagnosed COPD: a randomised controlled trial
          Michael G. Crooks, Jack Elkes, William Storrar, Kay Roy, Mal North, Alison Blythin, Alastair Watson, Victoria Cornelius, Tom M.A. Wilkinson
          ERJ Open Research Oct 2020, 6 (4) 00460-2020; DOI: 10.1183/23120541.00460-2020

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          Evidence generation for the clinical impact of myCOPD in patients with mild, moderate and newly diagnosed COPD: a randomised controlled trial
          Michael G. Crooks, Jack Elkes, William Storrar, Kay Roy, Mal North, Alison Blythin, Alastair Watson, Victoria Cornelius, Tom M.A. Wilkinson
          ERJ Open Research Oct 2020, 6 (4) 00460-2020; DOI: 10.1183/23120541.00460-2020
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