title: Home telemonitoring for patients with acute exacerbation of chronic obstructive pulmonary disease: a randomized controlled trial.
abstract: Although a number of studies have suggested that the use of Telemonitoring (TM) in patients with Chronic Obstructive Pulmonary Disease (COPD) can be useful and efficacious, its real utility in detecting Acute Exacerbation (AE) signaling the need for prompt treatment is not entirely clear. The current study aimed to investigate the benefits of a TM system in managing AE in advanced-stage COPD patients to improve their Health-Related Quality of Life (HRQL) and to reduce utilization of healthcare services.
  
  
  
  A 12-month Randomised Controlled Trial (RCT) was conducted in the Veneto region (Italy). Adult patients diagnosed with Class III-IV COPD in accordance with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification were recruited and provided a TM system to alert the clinical staff via a trained operator whenever variations in respiratory parameters fell beyond the individual's normal range. The study's primary endpoint was HRQL, measured by the Italian version of the two Short Form 36-item Health Survey (SF36v2). Its secondary endpoints were: scores on the Hospital Anxiety and Depression Scale (HADS); the number and duration of hospitalizations; the number of readmissions; the number of appointments with a pulmonary specialist; the number of visits to the emergency department; and the number of deaths.
  
  
  
  Three hundred thirty-four patients were enrolled and randomized into two groups for a 1 year period. At its conclusion, changes in the SF36 Physical and Mental Component Summary scores did not significantly differ between the TM and control groups [(-2.07 (8.98) vs -1.91 (7.75); p = 0.889 and -1.08 (11.30) vs -1.92 (10.92); p = 0.5754, respectively]. Variations in HADS were not significantly different between the two groups [0.85 (3.68) vs 0.62 (3.6); p = 0.65 and 0.50 (4.3) vs 0.72 (4.5); p = 0.71]. The hospitalization rate for AECOPD and/or for any cause was not significantly different in the two groups [IRR = 0.89 (95% CI 0.79-1,04); p = 0.16 and IRR = 0.91 (95% CI 0,75 - 1.04); p = 0.16, respectively]. The readmission rate for AECOPD and/or any cause was, however, significantly lower in the TM group with respect to the control one [IRR = 0.43 (95% CI 0.19-0.98); p = 0.01 and 0.46 (95% CI 0.24-0.89); p = 0.01, respectively].
  
  
  
  Study results showed that in areas where medical services are well established, TM does not significantly improve HRQL in patients with COPD who develop AE. Although not effective in reducing hospitalizations, TM can nevertheless facilitate continuity of care during hospital-to-home transition by reducing the need for early readmission.
  
  
  
  Retrospectively registered on January 2012, ClinicalTrials.gov Identifier: NCT01513980 .
authors.affiliation: Respiratory Pathophysiology Division, University-City Hospital of Padova, Padova, Italy. andrea.vianello@sanita.padova.it.|U.O. Fisiopatologia Respiratoria, Azienda Ospedaliera di Padova, Via Giustiniani, 1, 35128, Padova, Italy. andrea.vianello@sanita.padova.it.
authors.forename: Andrea
authors.initials: A
authors.lastname: Vianello
authors.affiliation: Local Health Authority of Venezia, Venezia, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Fusello
authors.affiliation: Veneto Region Health Information System, Venezia, Italy.
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Gubian
authors.affiliation: Respiratory Pathophysiology Division, University-City Hospital of Padova, Padova, Italy.
authors.forename: Claudia
authors.initials: C
authors.lastname: Rinaldo
authors.affiliation: Arsenàl.IT, Veneto Research Centre for e-Health Innovation, Treviso, Italy.
authors.forename: Claudio
authors.initials: C
authors.lastname: Dario
authors.affiliation: Respiratory Pathophysiology Division, University-City Hospital of Padova, Padova, Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Concas
authors.affiliation: Arsenàl.IT, Veneto Research Centre for e-Health Innovation, Treviso, Italy.
authors.forename: Claudio
authors.initials: C
authors.lastname: Saccavini
authors.affiliation: Respiratory Pathophysiology Division, University-City Hospital of Padova, Padova, Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Battistella
authors.affiliation: Arsenàl.IT, Veneto Research Centre for e-Health Innovation, Treviso, Italy.
authors.forename: Giulia
authors.initials: G
authors.lastname: Pellizzon
authors.affiliation: Division of Pulmunology, City Hospital of Treviso, Treviso, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Zanardi
authors.affiliation: Arsenàl.IT, Veneto Research Centre for e-Health Innovation, Treviso, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Mancin
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D018450:Disease Progression; D005260:Female; D006699:Home Care Services; D006801:Humans; D007558:Italy; D008297:Male; D008991:Monitoring, Physiologic; D010343:Patient Admission / Q000706:statistics & numerical data*; D029424:Pulmonary Disease, Chronic Obstructive / Q000503:physiopathology*; D011788:Quality of Life; D012189:Retrospective Studies; D012720:Severity of Illness Index; D017216:Telemedicine
keywords: Chronic obstructive pulmonary disease; Health-related quality of life; Hospitalization; Telemonitoring