Life-long Monitoring of COPD in Veneto Region

Summary

The purpose of this study is to evaluate whether the introduction of large-scale telemonitoring of patients with COPD produces benefits in terms of improved health-related quality of life and reduced access to hospital facilities. In addition, the trial evaluates the economic and organisational impact of the new services, and examine their acceptability by patients and health professionals.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

PROCEDURE

self-monitoring for patients with severe COPD

Patients are equipped with a telemonitoring kit composed by a portable wrist-clinic device for clinical parameters measuring and a gateway device for data transmission. The patient can monitor pulse-oxymetry and heart rate with a frequency set by the clinician in the personalised treatment plan. Data are transmitted to a regional eHealth centre where a group of operators keeps these information under control and alert the reference clinician in case of worsening of symptoms. CAT questionnaire is monthly administrated by phone to the patients

PROCEDURE

nurse-monitoring for patients with severe COPD

A nurse is in charge of data collection during home visits with a frequency set by the lung specialist depending to the patient clinical conditions. The nurse uses portable biomedical devices to measure pulse-oxymetry, heart rate, spirometry and if scheduled an arterial blood gas test. Data are transmitted to the clinician who checks them on his laptop in the hospital and completes the visit with the medical report.

Sponsors & Collaborators

• European Commission

  collaborator OTHER

• Azienda Unità Locale Socio Sanitaria n.9 Treviso

  collaborator OTHER

• Azienda ULSS 12 Veneziana

  collaborator OTHER

• Azienda ULSS di Verona e Provincia

  collaborator OTHER

• Azienda ULSS 16 Padova

  collaborator OTHER

• Azienda Ospedaliera di Padova

  collaborator OTHER

• Azienda Ospedaliera Universitaria Integrata Verona

  collaborator OTHER

• Regione Veneto

  lead OTHER

Principal Investigators

• Massimo Fusello, MD · Local Health authority Veneziana

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-11-30

Primary Completion

2014-05-31

Completion

2014-05-31

Countries

• Italy

Study Locations