Udsen 2017.

Study characteristics
Methods	Study design: multi‐centre, open‐label, parallel cluster randomised controlled trial in Denmark Duration: 52 weeks Setting: primary care
Participants	Population: 1225 adults recruited from 26 municipal districts in the North Denmark region Baseline characteristics: % Male: 48.3 RM and 43.7 UC, Mean age: 69.6 RM and 70.3 UC, % 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 47.7 and UC 48.4, FVC (% mean): RM 70.4 and UC 73.3, FEV₁/FVC (% mean): not reported, Current smokers (n): RM 196 and UC 189, GOLD stage: I, II, III, IV COPD exacerbations last 12 months: not reported, Hospitalisations in past 12 months: not reported Inclusion criteria: COPD diagnosis by spirometry, treated according to GOLD guidelines, wanting to get COPD treatment, COPD the primary condition, residing permanently in the North Denmark region, MRC modified ≥ 2 or MRC ≥ 3 or CAT ≥ 10, at least 2 exacerbations in the last year Exclusion criteria: no phone line or GSM coverage, unable to speak or understand Danish to complete questionnaires, cognitive impairment
Interventions	Measurements taken at baseline and at 12 months Treatment arms Tablet computer used to collect disease‐specific data (measured vital signs and COPD symptoms) Usual care practice
Outcomes	Primary outcomes: quality of life (SF‐36 physical and mental composite subscale scores) Secondary outcomes: incremental cost‐effectiveness ratio
Notes	Funding: North Denmark Region, 11 municipalities in the North Denmark Region; Obel Family Foundation; Danish Agency for Digitalization Policy Strategy; European Social Fund Other identifier: NCT01984840
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Districts were distributed randomly by a blinded volunteer with no relation to the trial, who performed randomisation by throwing a dice
Allocation concealment (selection bias)	Low risk	Randomisation of clusters was done by sealed envelopes overseen by a person not affiliated with the trial
Blinding of participants and personnel (performance bias) All outcomes	High risk	Trial was open‐label
Blinding of outcome assessment (detection bias) All outcomes	High risk	Trial was open‐label
Incomplete outcome data (attrition bias) All outcomes	High risk	Attrition was similar in both groups; however, more people in the THC group withdrew consent to the intervention compared to the UC group. Overall, attrition was high, with 50% of participants dropping out of the study. 61% of participants at all cost categories and EQ‐5D summary scores had completed registration
Selective reporting (reporting bias)	Low risk	All outcomes were reported as planned; trial was registered at clinicaltrials.gov
Other bias	Low risk	None