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Life-long Monitoring of COPD in Veneto Region

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01513980
First Posted: January 20, 2012
Last Update Posted: April 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
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
  Purpose
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
Intervention Model: Parallel Assignment
Masking: Single (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 ]
    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 ]
  • Number of specialist visits [ Time Frame: 12 months ]
  • Number of visits to emergency department [ Time Frame: 12 months ]
  • All cause mortality [ Time Frame: 12 months ]
  • Anxiety and depression status [ Time Frame: 12 months ]
    Anxiety and depression status is assessed by Hospital Anxiety and Depression Scale, (HADS).

  • Number of re-hospitalizations [ Time Frame: 12 months ]

Enrollment: 750
Study Start Date: November 2011
Study Completion Date: May 2014
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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01513980


Locations
Italy
Ospedale dell'Angelo - Pulmonology Department
Mestre, Venezia, Italy, 30174
Ospedale di Marzana - Rehabilitative respiratory unit
Marzana, Verona, Italy, 37034
Local Health Autority n.16 Padova - Pulmonology outpatient clinic
Padova, Italy, 35127
Hospital Trust of Padova - Respiratory Physiopathology Department
Padova, Italy, 35128
Ospedale Ca'Foncello - Pulmonology Department
Treviso, Italy, 31100
Hospital Trust of Verona - Pneumonology Department
Verona, Italy, 37124
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
Investigators
Principal Investigator: Massimo Fusello, MD Local Health authority Veneziana
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Regione Veneto
ClinicalTrials.gov Identifier: NCT01513980     History of Changes
Other Study ID Numbers: G. A. 250487-Veneto WP8Cl5
First Submitted: January 17, 2012
First Posted: January 20, 2012
Last Update Posted: April 17, 2017
Last Verified: January 2012
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Regione Veneto:
Chronic Obstructive Pulmonary Disease
Telemonitoring

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive