Calvo 2014.

Study characteristics
Methods	Study design: multi‐centre, open‐label, parallel cluster‐randomised controlled trial in Spain Duration: 30 weeks Setting: pneumology services and primary care centres
Participants	Population: 60 adults recruited from pneumology services at Hospital University La Princesa, Primary Care Centres, in its area including Goya, Montesa, Lagasca, and Castello, and other primary care centres in the district of Salamanca in Madrid but not identified Baseline characteristics: % Male: 75.9 TH and 73.3 UC, Mean age: 75 TH and 72.7 UC, % White: not reported, % African: not reported, % LTOT: 100 TH and 100 UC, % Home oxygen: not reported, % Anxiety or depression: TH 3.70 anxiety and 3.80 depression, UC 3.0 anxiety and 3.5 depression, Baseline medications: 83% LAMA + LABA + ICS; 13% PDE4 inhibitors; 39% mucolytics; 8% theophyllines; 8% oral steroids, FEV₁ (% mean): TH 38.3 and UC 37.1, FVC (% mean): not reported, FEV₁/FVC (% mean): not reported, Current smokers (n): none for last 6 months, GOLD stage: severe to very severe, COPD exacerbations last 12 months: not reported, Hospitalisations in past 12 months: TH: 1.7 ± 1.0 and UC: 1.9 ± 1.4 Inclusion criteria: prior COPD diagnosis according to GOLD criteria 2011, severe/very severe FEV₁/FVC < 0.70 and % FEV₁ < 50, age ≥ 50 years, long‐term home oxygen therapy, not a current smoker for at least 6 months Exclusion criteria: did not meet at least 1 of the inclusion criteria, enrolled in palliative care programme for lung or other disease, at risk for social exclusion or institutionalised, deemed unable to understand all procedures
Interventions	Run‐in: patients entering study had to be in stable situation and 15 days free of COPD exacerbation; initial clinic visit Treatment arms Home telehealth monitoring Usual care (continued with scheduled medical visits by pneumologist or primary care physician)
Outcomes	Primary outcomes: numbers of emergency room visits, hospitalisations; length of hospital stay; mortality Secondary outcomes: none listed
Notes	Funding: Linde Healthcare Other identifier: NCT02499068
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Patients were randomised by a 2‐colour code, either individually randomised or cluster‐randomised (depending on location of referral); not enough information
Allocation concealment (selection bias)	Low risk	Allocation was achieved by using coloured envelopes selected at chance
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open‐label study; neither study investigators nor patients were blinded
Blinding of outcome assessment (detection bias) All outcomes	High risk	Open‐label study; neither study investigators nor patients were blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	Low withdrawal rates: 2/30 patients withdrew from treatment arm, none from conventional care arm
Selective reporting (reporting bias)	Unclear risk	No further information about trial registration or whether outcomes reported were planned
Other bias	Low risk	None