Farmer 2017.
Study characteristics | ||
Methods |
Study design: multi centre, open‐label, parallel randomised controlled trial in the UK Duration: 52 weeks Setting: secondary care, primary care, community services |
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Participants |
Population: 166 adults recruited from respiratory hospital outpatient clinics and primary care Baseline characteristics: male: 62% IG and 61% CG, mean age: 69.8 IG and 69.8 CG, median number of COPD medication: 5 IG and 5 CG, FEV1 (% predicted): 47.4 IG and 50.1 CG, ex‐smoker: 79% IG and 76% CG, current smoker: 20.9% IG and 23.3% CG, severe or very severe COPD: 63% IG and 59% CG Inclusion criteria: COPD diagnosis, FEV1 post bronchodilation < 80% and predicted FEV/FVC ratio < 0.70, smoking > 10 pack years, MRC dyspnoea >= 2, registered with a GP and had a COPD exacerbation in the 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 | Measurements were taken at baseline and 12 months follow‐up. Treatment arms:
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Outcomes |
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Notes |
Funding: Wellcome Trust and Department of Health Other identifiers: ISRCTN40367841 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | A computer programme (Sortiton V1.2) was used to randomise participants. |
Allocation concealment (selection bias) | Unclear risk | It is unclear whether the allocation was concealed or not. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Neither the study investigators or patients were blinded. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Open‐label study |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition was similar in each treatment group, with 15.5% lost to follow‐up in the intervention arm and 14.3% lost to follow‐up from the control arm. |
Selective reporting (reporting bias) | Low risk | Outcomes were reported as planned. |
Other bias | Low risk | None detected. |