Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Life-long Monitoring of COPD in Veneto Region

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Regione Veneto.
Recruitment status was  Recruiting
European Commission
Azienda Unità Locale Socio Sanitaria n.9 Treviso
Azienda ULSS 12 Veneziana
Azienda ULSS di Verona e Provincia
Azienda ULSS 16 Padova
Azienda Ospedaliera di Padova
Azienda Ospedaliera Universitaria Integrata Verona
Information provided by (Responsible Party):
Regione Veneto Identifier:
First received: January 17, 2012
Last updated: January 21, 2014
Last verified: January 2012

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.

Condition Intervention
Pulmonary Disease, Chronic Obstructive
Procedure: self-monitoring for patients with severe COPD
Procedure: nurse-monitoring for patients with severe COPD

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: RENEWING HEALTH - Large Scale Pilot in Veneto Region: Life-long Monitoring in COPD

Resource links provided by NLM:

Further study details as provided by Regione Veneto:

Primary Outcome Measures:
  • Health-Related quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Health-Related Quality of Life is assessed by the SF-36 questionnaire

Secondary Outcome Measures:
  • Number of bed days for hospitalised patients [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of specialist visits [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of visits to emergency department [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • All cause mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Anxiety and depression status [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Anxiety and depression status is assessed by Hospital Anxiety and Depression Scale, (HADS).

  • Number of re-hospitalizations [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 750
Study Start Date: November 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01513980

Contact: Massimo Fusello, MD 041 2608805
Contact: Gianluigi Scannapieco, MD 0422323232

Ospedale dell'Angelo - Pulmonology Department Recruiting
Mestre, Venezia, Italy, 30174
Principal Investigator: Loris Ceron, MD         
Ospedale di Marzana - Rehabilitative respiratory unit Recruiting
Marzana, Verona, Italy, 37034
Principal Investigator: Stefano Zeminian, MD         
Principal Investigator: Guido Polese, MD         
Hospital Trust of Padova - Respiratory Physiopathology Department Recruiting
Padova, Italy, 35128
Principal Investigator: Andrea Vianello, MD         
Local Health Autority n.16 Padova - Pulmonology outpatient clinic Recruiting
Padova, Italy, 35127
Principal Investigator: Beatrice Nordio, MD         
Ospedale Ca'Foncello - Pulmonology Department Recruiting
Treviso, Italy, 31100
Principal Investigator: Alberto Durigato, MD         
Hospital Trust of Verona - Pneumonology Department Recruiting
Verona, Italy, 37124
Principal Investigator: Andrea Rossi, MD         
Sponsors and Collaborators
Regione Veneto
European Commission
Azienda Unità Locale Socio Sanitaria n.9 Treviso
Azienda ULSS 12 Veneziana
Azienda ULSS di Verona e Provincia
Azienda ULSS 16 Padova
Azienda Ospedaliera di Padova
Azienda Ospedaliera Universitaria Integrata Verona
Principal Investigator: Massimo Fusello, MD Local Health authority Veneziana
  More Information

Additional Information:
No publications provided

Responsible Party: Regione Veneto Identifier: NCT01513980     History of Changes
Other Study ID Numbers: G. A. 250487-Veneto WP8Cl5
Study First Received: January 17, 2012
Last Updated: January 21, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by Regione Veneto:
Chronic Obstructive Pulmonary Disease

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases processed this record on November 24, 2014