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. 2021 Jul 20;2021(7):CD013196. doi: 10.1002/14651858.CD013196.pub2

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
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
Interventions Measurements taken at baseline, monthly, and at end of study
Treatment arms
  1. Docobo HealthHub portable equipment installed at patient's home with education booklet about COPD and TM manual

  2. Control: educational booklet about COPD

Outcomes Primary outcomes: health services usage, annual cost savings, quality of life, participant satisfaction
Secondary outcomes: none
Notes Funding: Australian Department of Health and Ageing
Other identifier: none
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