NCT01513980

Life-long Monitoring of COPD in Veneto Region

RENEWING HEALTH - Large Scale Pilot in Veneto Region: Life-long Monitoring in COPD

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 750 (actual)
• Sponsor: Regione Veneto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study is designed to evaluate the impact of telemonitoring on the management of COPD compared with outpatient usual care. From a clinical point of view, the trial will allow to investigate how telemonitoring contributes to improve COPD patients health-related quality of life and reduct the access to hospital facilities (re-hospitalizations, bed-days, specialistic and ER visits) and the anxiety about health conditions. A cost-effectiveness and cost-utility analysis will be carried out in order to determine if and how telemonitoring helps to limit the healthcare expenditure. The evaluation will deal also with organizational changes and task shift due to telemonitoring introduction and patients and professionals perception towards the service.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2012-01-20
• Last updated: 2017-04-17

Locations

6 sites across 1 country: Italy