Life-long Monitoring of COPD in Veneto Region
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
self-monitoring for patients with severe COPD
nurse-monitoring for patients with severe COPD
Sponsored by
About this trial
This is an interventional supportive care trial for Pulmonary Disease, Chronic Obstructive focused on measuring Chronic Obstructive Pulmonary Disease, Telemonitoring
Eligibility 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).
Sites / Locations
- Ospedale dell'Angelo - Pulmonology Department
- Ospedale di Marzana - Rehabilitative respiratory unit
- Local Health Autority n.16 Padova - Pulmonology outpatient clinic
- Hospital Trust of Padova - Respiratory Physiopathology Department
- Ospedale Ca'Foncello - Pulmonology Department
- Hospital Trust of Verona - Pneumonology Department
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Control group
Self monitoring for patients with COPD
Nurse monitoring for patients with COPD
Arm Description
Treatment as usual
Procedure: self-monitoring for patients with severe COPD
Procedure: nurse-monitoring for patients with severe COPD
Outcomes
Primary Outcome Measures
Health-Related quality of life
Health-Related Quality of Life is assessed by the SF-36 questionnaire
Secondary Outcome Measures
Number of bed days for hospitalised patients
Number of specialist visits
Number of visits to emergency department
All cause mortality
Anxiety and depression status
Anxiety and depression status is assessed by Hospital Anxiety and Depression Scale, (HADS).
Number of re-hospitalizations
Full Information
NCT ID
NCT01513980
First Posted
January 17, 2012
Last Updated
April 13, 2017
Sponsor
Regione Veneto
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
1. Study Identification
Unique Protocol Identification Number
NCT01513980
Brief Title
Life-long Monitoring of COPD in Veneto Region
Official Title
RENEWING HEALTH - Large Scale Pilot in Veneto Region: Life-long Monitoring in COPD
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regione Veneto
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
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Chronic Obstructive Pulmonary Disease, Telemonitoring
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
750 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Treatment as usual
Arm Title
Self monitoring for patients with COPD
Arm Type
Experimental
Arm Description
Procedure: self-monitoring for patients with severe COPD
Arm Title
Nurse monitoring for patients with COPD
Arm Type
Experimental
Arm Description
Procedure: nurse-monitoring for patients with severe COPD
Intervention Type
Procedure
Intervention Name(s)
self-monitoring for patients with severe COPD
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
nurse-monitoring for patients with severe COPD
Intervention Description
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.
Primary Outcome Measure Information:
Title
Health-Related quality of life
Description
Health-Related Quality of Life is assessed by the SF-36 questionnaire
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of bed days for hospitalised patients
Time Frame
12 months
Title
Number of specialist visits
Time Frame
12 months
Title
Number of visits to emergency department
Time Frame
12 months
Title
All cause mortality
Time Frame
12 months
Title
Anxiety and depression status
Description
Anxiety and depression status is assessed by Hospital Anxiety and Depression Scale, (HADS).
Time Frame
12 months
Title
Number of re-hospitalizations
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Massimo Fusello, MD
Organizational Affiliation
Local Health authority Veneziana
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale dell'Angelo - Pulmonology Department
City
Mestre
State/Province
Venezia
ZIP/Postal Code
30174
Country
Italy
Facility Name
Ospedale di Marzana - Rehabilitative respiratory unit
City
Marzana
State/Province
Verona
ZIP/Postal Code
37034
Country
Italy
Facility Name
Local Health Autority n.16 Padova - Pulmonology outpatient clinic
City
Padova
ZIP/Postal Code
35127
Country
Italy
Facility Name
Hospital Trust of Padova - Respiratory Physiopathology Department
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Ospedale Ca'Foncello - Pulmonology Department
City
Treviso
ZIP/Postal Code
31100
Country
Italy
Facility Name
Hospital Trust of Verona - Pneumonology Department
City
Verona
ZIP/Postal Code
37124
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27876029
Citation
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.
Results Reference
derived
Links:
URL
http://www.renewinghealth.eu
Description
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
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Life-long Monitoring of COPD in Veneto Region
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