Life-long Monitoring of COPD in Veneto Region

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01513980
• Other study ID #: G. A. 250487-Veneto WP8Cl5
• Status: Completed
• Phase: N/A
• First received: January 17, 2012
• Last updated: April 13, 2017
• Start date: November 2011
• Est. completion date: May 2014

Study information

• Verified date: January 2012
• Source: Regione Veneto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years.

• COPD GOLD class 3-4

• Life expectance > 12 months

Exclusion Criteria:

• Patient unable to use the equipment provided (alone or assisted).

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

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
• 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.

Locations

Country	Name	City	State
Italy	Ospedale di Marzana - Rehabilitative respiratory unit	Marzana	Verona
Italy	Ospedale dell'Angelo - Pulmonology Department	Mestre	Venezia
Italy	Hospital Trust of Padova - Respiratory Physiopathology Department	Padova
Italy	Local Health Autority n.16 Padova - Pulmonology outpatient clinic	Padova
Italy	Ospedale Ca'Foncello - Pulmonology Department	Treviso
Italy	Hospital Trust of Verona - Pneumonology Department	Verona

Sponsors (8)

Lead Sponsor	Collaborator
Regione Veneto	Azienda Ospedaliera di Padova, Azienda Ospedaliera Universitaria Integrata Verona, Azienda ULSS 12 Veneziana, Azienda ULSS 16 Padova, Azienda ULSS di Verona e Provincia, Azienda Unità Locale Socio Sanitaria n.9 Treviso, European Commission

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health-Related quality of life	Health-Related Quality of Life is assessed by the SF-36 questionnaire	12 months
Secondary	Number of bed days for hospitalised patients		12 months
Secondary	Number of specialist visits		12 months
Secondary	Number of visits to emergency department		12 months
Secondary	All cause mortality		12 months
Secondary	Anxiety and depression status	Anxiety and depression status is assessed by Hospital Anxiety and Depression Scale, (HADS).	12 months
Secondary	Number of re-hospitalizations		12 months

External Links

•   The Renewing Health project is partially funded under the ICT Policy Support Programme (ICT PSP) as part of the Competitiveness and Innovation Framework Programme by the European Community