Farmer 2017.
| Study characteristics | ||
| Methods |
Study design: multi‐centre, open‐label, parallel individual randomised trial in United Kingdom Duration: 52 weeks Setting: primary and secondary care clinics |
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| Participants |
Population: 166 adults recruited from primary and secondary care, respiratory hospital outpatient clinics, pulmonary rehab courses in adjacent counties of Oxfordshire and Berkshire, UK Baseline characteristics: % Male: 61.8 RM and 60.7 UC, Mean age: 69.8 RM and 69.8 UC, % White: not reported, % African: not reported, % LTOT: not reported, % Home oxygen: not reported, % Anxiety or depression: not reported, Baseline medications: RM group: median 5 COPD medications and UC group median 5 COPD medications; RM group took median 4 other medications and UC group took 5 other medications, FEV₁ (% mean): RM 47.4 and UC 50.1, FVC (% mean): RM 47.6 and UC 49.8, FEV₁/FVC (% mean): not reported, Current smokers (n): RM 23 and UC 13, GOLD stage: RM: 37.3% moderate, 62.7% severe/very severe; UC: 41.1% moderate, 58.9% were severe/very severe, COPD exacerbations in last 12 months: not reported, Hospitalisations in past 12 months: not reported Inclusion criteria: COPD diagnosis FEV₁, post bronchodilation < 80% and predicted FEV₁:FVC ratio < 0.70. Smoking > 10 pack‐years, MRC dyspnoea ≥ 2, registered with GP and COPD exacerbation in last 12 months, or referred to PR Exclusion criteria: other significant lung disease, chronic heart failure, life expectancy < 3 months, cognitive impairment, no Internet‐enabled mobile phone network |
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| Interventions |
Run‐in: initial 6‐week period of EDGE platform, symptom diary, and physiological measurements done daily; measurements taken at baseline and at 3, 6, and 12 months Treatment arms
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| Outcomes |
Primary outcomes: quality of life scales: SGRQ‐C Secondary outcomes: hospital admissions, length of stay, deaths, number of recorded exacerbations, antibiotic/oral steroid use, presenting at ED or admitted to hospital due to acute change in respiratory condition, time to first exacerbation, EQ‐5D, Anxiety (SCL‐10A), depression (SCL‐20) |
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| Notes |
Funding: Health Innovation Challenge fund (Wellcome Trust, Dept of Health). Trial was sponsored by University of Oxford. Study authors received funding from NIHR and Biomedical Research Centre (BRC) Other identifier: ISRCTN 40367841 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | A computer programme (Sortition V1.2) was used to randomise participants. Research nurse carried out randomisation by accessing Sortition using Web browser on a tablet computer at assessment visit only after completion of consent procedures and baseline measurements |
| Allocation concealment (selection bias) | Unclear risk | Allocation of participants was carried out in 2:1 ratio of intervention and usual care. However, it is unclear whether allocation was concealed. Research nurse carried out randomisation |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Open‐label study; neither study investigators nor patients were blinded |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Open‐label study; neither study investigators nor patients were blinded |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Attrition was similar in each treatment group, with similar numbers, although more deaths occurred in the intervention group. 14/110 (12.7%) in intervention arm withdrew, 7/56 (12.5%) from control arm withdrew. An additional 5 allocated to intervention did not receive the intervention; this is unclear |
| Selective reporting (reporting bias) | Low risk | Outcomes were reported as planned; study authors provided data on request |
| Other bias | Low risk | None |