Stamenova 2020.
Study characteristics | ||
Methods |
Study design: open‐label, parallel randomised controlled trial in Canada Duration: 26 weeks Setting: secondary care |
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Participants |
Population: 122 adults (18+) with COPD recruited Baseline characteristics: mean age: 72 years; male: 55%; current smokers (%): 20%; FEV1 (L): median ; Never used technology (%): 77%; COPD exacerbations in the last year: median 1‐2 exacerbations. Inclusion criteria: COPD clinical diagnosis Exclusion criteria: diagnosis of other significant lung disease or dementia, no Internet access in home, inability to read English, participation in other remote monitoring programs, inability to use technology due to physical or cognitive impairment |
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Interventions | Measurements taken at baseline, 3 months, and 6 months follow‐up. Treatment arms:
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Outcomes |
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Notes |
Funding: Ontario Centres of Excellence Health Technologies Fund Other identifiers: NCT03741855 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | A web‐based random number generator was used to randomise patients. |
Allocation concealment (selection bias) | Low risk | Sealed envelopes were used to assign allocation. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open‐label study, neither the participants nor investigators were blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | It is not clear if outcome assessors are blinded or not. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition was 12.5% at three months and 17.5% at six months for the intervention group, and 4.9% at three months and 14.6% at six months for the control group. |
Selective reporting (reporting bias) | Low risk | Outcomes appear to be reported as identified in the protocol. |
Other bias | Low risk | None identified. |