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. 2021 Apr 19;2021(4):CD013246. doi: 10.1002/14651858.CD013246.pub2

Stamenova 2020.

Study characteristics
Methods Study design: open‐label, parallel randomised controlled trial in Canada
Duration: 26 weeks
Setting: secondary care
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
Interventions Measurements taken at baseline, 3 months, and 6 months follow‐up.
Treatment arms:
  • Technology‐enabled self‐monitoring programme

  • Technology‐enabled remote monitoring programme

  • Standard care

Outcomes
  • Self‐management (PIH scale)

  • Quality of Life (SGRQ, CAT)

  • Knowldge (Bristol COPD Knowledge Questionnaire)

  • Healthcare utilisation (hospital admissions and length of stay, COPD‐related visits to GP, nurse contacts)

  • Exacerbations

  • Impact on health behaviour (smoking cessation)

Notes Funding: Ontario Centres of Excellence Health Technologies Fund
Other identifiers: NCT03741855
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.