Life-long Monitoring of COPD in Veneto Region

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Procedure: self-monitoring for patients with severe COPD; Procedure: nurse-monitoring for patients with severe COPD

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 Type: Interventional
• Enrollment (Actual): 750
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Padova, Italy, 35127
    • Local Health Autority n.16 Padova - Pulmonology outpatient clinic
  • Padova, Italy, 35128
    • Hospital Trust of Padova - Respiratory Physiopathology Department
  • Treviso, Italy, 31100
    • Ospedale Ca'Foncello - Pulmonology Department
  • Verona, Italy, 37124
    • Hospital Trust of Verona - Pneumonology Department
  • Venezia
    • Mestre, Venezia, Italy, 30174
      • Ospedale dell'Angelo - Pulmonology Department
  • Verona
    • Marzana, Verona, Italy, 37034
      • Ospedale di Marzana - Rehabilitative respiratory unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Treatment as usual
Experimental: Self monitoring for patients with COPD; Procedure: self-monitoring for patients with severe COPD	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
Experimental: Nurse monitoring for patients with COPD; Procedure: nurse-monitoring for patients with severe COPD	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-Related quality of life	Health-Related Quality of Life is assessed by the SF-36 questionnaire	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Regione Veneto
• Collaborators: Azienda Ospedaliera Universitaria Integrata Verona; Azienda Ospedaliera di Padova; European Commission; Azienda ULSS 16 Padova; Azienda Unità Locale Socio Sanitaria n.9 Treviso; Azienda ULSS di Verona e Provincia; Azienda ULSS 12 Veneziana
• Investigators: Principal Investigator: Massimo Fusello, MD, Local Health authority Veneziana

Publications and helpful links

General Publications

• Vianello A, Fusello M, Gubian L, Rinaldo C, Dario C, Concas A, Saccavini C, Battistella L, Pellizzon G, Zanardi G, Mancin S. Home telemonitoring for patients with acute exacerbation of chronic obstructive pulmonary disease: a randomized controlled trial. BMC Pulm Med. 2016 Nov 22;16(1):157. doi: 10.1186/s12890-016-0321-2.

Helpful 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

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: January 17, 2012
• First Submitted That Met QC Criteria: January 17, 2012
• First Posted (Estimate): January 20, 2012

Study Record Updates

• Last Update Posted (Actual): April 17, 2017
• Last Update Submitted That Met QC Criteria: April 13, 2017
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: Telemonitoring; Chronic Obstructive Pulmonary Disease
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: G. A. 250487-Veneto WP8Cl5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO