Life-long Monitoring of COPD in Veneto Region

Not Applicable

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Procedure: self-monitoring for patients with severe COPD; Procedure: nurse-monitoring for patients with severe COPD

• Registration Number: NCT01513980
• Lead Sponsor: Regione Veneto

Brief 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.

Study Timeline

• Study Start: 2011-11
• Status Verified: 2012-01
• Study First Submitted: 2012-01-17
• Study First Submitted QC: 2012-01-17
• Study First Posted: 2012-01-20
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Last Update Submitted: 2017-04-13
• Last Update Posted: 2017-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 750

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self monitoring for patients with COPD	self-monitoring for patients with severe COPD	Procedure: self-monitoring for patients with severe COPD
Nurse monitoring for patients with COPD	nurse-monitoring for patients with severe COPD	Procedure: nurse-monitoring for patients with severe COPD

Primary Outcome Measures

Name	Time	Method
Health-Related quality of life	12 months	Health-Related Quality of Life is assessed by the SF-36 questionnaire

Secondary Outcome Measures

Name	Time	Method
Number of bed days for hospitalised patients	12 months
Number of specialist visits	12 months
All cause mortality	12 months
Number of visits to emergency department	12 months
Anxiety and depression status	12 months	Anxiety and depression status is assessed by Hospital Anxiety and Depression Scale, (HADS).
Number of re-hospitalizations	12 months

Trial Locations

Locations (6)

Hospital Trust of Verona - Pneumonology Department; 🇮🇹 Verona, Italy

Local Health Autority n.16 Padova - Pulmonology outpatient clinic; 🇮🇹 Padova, Italy

Hospital Trust of Padova - Respiratory Physiopathology Department; 🇮🇹 Padova, Italy

Ospedale Ca'Foncello - Pulmonology Department; 🇮🇹 Treviso, Italy

Ospedale di Marzana - Rehabilitative respiratory unit; 🇮🇹 Marzana, Verona, Italy

Ospedale dell'Angelo - Pulmonology Department; 🇮🇹 Mestre, Venezia, Italy