Antoniades 2012.
Study characteristics | ||
Methods |
Study design: single‐centre, single‐blinded, parallel individual randomised controlled trial in Australia Duration: 52 weeks Setting: tertiary care hospital |
|
Participants |
Population: 44 adults recruited from a metropolitan tertiary care hospital Baseline characteristics: % Male: 45 RM + SBP and 45 SBP, Mean age: 68 RM + SBP and 70 SBP, % White: not reported, % African: not reported, % LTOT: not reported, % Home oxygen: not reported, % Anxiety or depression: not reported, Baseline medications: not reported, FEV₁ (% mean): RM + SBP 0.91, SBP 0.66, FVC (% mean): RM + SBP 2.13, SBP 1.98, FEV₁/FVC (% mean): RM + SBP 39.9, SBP 32, Current smokers (n): SBP + RM 0/22 and SBP 6/22, GOLD stage: moderate to severe on COPD criteria, COPD exacerbations lasting 12 months: not reported, Hospitalisations in past 12 months: RM + SBP: 2 (1 to 4) and SBP: 1 (1 to 2) Inclusion criteria: moderate to severe COPD diagnosed by COPD criteria, at least 1 hospitalisation in previous 12 months, fluent English, able to use keyboard and mouse, willing to use computer in self‐management, ambulant, living independently Exclusion criteria: significant comorbidities including cancer, renal failure, and cognitive impairment |
|
Interventions |
Run‐in: initial home training was provided to all participants by a nursing informatics project manager; measurements taken at baseline, 6 months, and 12 months Treatment arms
|
|
Outcomes |
Primary outcomes: hospital admissions (COPD‐related or non‐COPD‐related), inpatient bed‐days, quality of life (SF‐36 form and CRDQ form completed at 6 and 12 months) Secondary outcomes: 6‐minute walk distance (6MWD) measured at baseline and 12 months, adherence to daily monitoring, reproducibility of physiological measurements, patient acceptance of remote monitoring |
|
Notes |
Funding: Department of Human Services; Victoria, Australia Other identifier: ACTRN12611000112965 |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Reported as randomised; designations were randomly generated and sequentially numbered, but it is unclear how the sequence was generated |
Allocation concealment (selection bias) | Low risk | Patients were randomly allocated to either group, using a set of sequentially numbered, opaque, sealed envelopes containing randomly generated designations |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Unable to blind patients and personnel due to nature of treatment |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Assumed that outcome assessors were not blinded because study was open‐label |
Incomplete outcome data (attrition bias) All outcomes | High risk | 27% vs 9% withdrawals in TM group vs standard best practice group, respectively |
Selective reporting (reporting bias) | Low risk | Outcomes reported as planned; trial registered in Australian registry website |
Other bias | Low risk | None |