A multicentre, randomized controlled trial of telehealth for the management of COPD.

BACKGROUND: Evidence is needed to determine the role of telehealth (TH) in COPD management. METHODS: PROMETE II was a multicentre, randomized, 12-month trial. Severe COPD patients in stable condition were randomized to a specific monitoring protocol with TH or routine clinical practice (RCP). The primary objective was to reduce the number of COPD exacerbations leading to ER visits/hospital admissions between groups. RESULTS: Overall, 237 COPD patients were screened, and 229 (96.6%) were randomized to TH (n = 115) or RCP (n = 114), with age of 71 ±â€¯8 years and 80% were men. Overall, 169 completed the full follow-up period. There were no statistical differences at one year between groups in the proportion of participants who had a COPD exacerbation (60% in TH vs. 53.5% in RCP; p = 0.321). There was, however, a marked but non-significant trend towards a shorter duration of hospitalization and days in ICU in the TH group (18.9 ±â€¯16.0 and 6.0 ±â€¯4.6 days) compared to the RCP group (22.4 ±â€¯19.5 and 13.3 ±â€¯11.1 days). The number of all-cause deaths was comparable between groups (12 in TH vs. 13 in RCP) as was total resource utilization cost (7912€ in TH vs. 8918€ in RCP). Telehealth was evaluated highly positively by patients and doctors. CONCLUSIONS: Remote patient management did not reduce COPD-related ER visits or hospital admissions compared to RCP within 12 months.