De San Miguel 2013.
Study characteristics | ||
Methods |
Study design: single‐centre, single‐blinded, parallel individual randomised controlled trial in Western Australia Duration: 26 weeks Setting: health and community care organisation based in Western Australia |
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Participants |
Population: 80 adults recruited from Western region of Australia Baseline characteristics: % Male: 38.9 RM and 57 UC, Mean age: 71 RM and 74 UC, % White: not reported, % African: not reported, % LTOT: not reported, % Home oxygen: not reported, % Anxiety or depression: not reported, Baseline medications: oxygen, FEV₁ (% mean): not reported, FVC (% mean): not reported, FEV₁/FVC (% mean): not reported, Current smokers (n): not reported, GOLD stage: not reported, COPD exacerbations last 12 months: not reported, Hospitalisations in past 12 months: not reported Inclusion criteria: COPD diagnosis, receiving domiciliary oxygen, English speaking, living in metropolitan area Exclusion criteria: dementia, receiving palliative care, no telephone land line, unable to use telehealth equipment due to cognitive impairment/physical impairment |
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Interventions | Measurements taken at baseline, monthly, and at end of study Treatment arms
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Outcomes |
Primary outcomes: health services usage, annual cost savings, quality of life, participant satisfaction Secondary outcomes: none |
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Notes |
Funding: Australian Department of Health and Ageing Other identifier: none |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Before recruitment, random number generator in STATA version 9 was used to randomly allocate 80 study numbers to intervention or control group (40 in each) |
Allocation concealment (selection bias) | Low risk | Envelopes were made up with study number written on the outside and group assignment on the inside |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No further information provided, but not possible to blind patients or personnel due to nature of intervention |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No further information provided |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 9/80 patients withdrew from the study (11.25%) (7 deceased, 2 withdrawn). Of 2 participants who withdrew, 1 was unable to manage the equipment, and 1 was no longer interested in taking part. Unclear which allocations patients who withdrew came from |
Selective reporting (reporting bias) | Unclear risk | No registry information found; unclear if outcomes reported as planned |
Other bias | Low risk | None |