Pulmonary Disease, Chronic ObstructiveNCT01513980
Life-long Monitoring of COPD in Veneto Region
A study testing self-monitoring for patients with severe COPD and nurse-monitoring for patients with severe COPD in people with Pulmonary Disease, Chronic Obstructive, run by Regione Veneto at 6 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- self-monitoring for patients with severe COPD and nurse-monitoring for patients with severe COPD
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 6 sitesItaly
- Study dates
- Nov 2011to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- COPD GOLD class 3-4
- Life expectance > 12 months
Who cannot join
- Patient unable to use the equipment provided (alone or assisted).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites
Ospedale di Marzana - Rehabilitative respiratory unit
Marzana, Verona, 37034
Ospedale dell'Angelo - Pulmonology Department
Mestre, Venezia, 30174
Local Health Autority n.16 Padova - Pulmonology outpatient clinic
Padova, Padova, 35127
Hospital Trust of Padova - Respiratory Physiopathology Department
Padova, Padova, 35128
Ospedale Ca'Foncello - Pulmonology Department
Treviso, Treviso, 31100
Hospital Trust of Verona - Pneumonology Department
Verona, Verona, 37124
About this study
Official title: 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.
Read the 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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- self-monitoring for patients with severe COPD, nurse-monitoring for patients with severe COPD
- Keywords
- Chronic Obstructive Pulmonary Disease, Telemonitoring
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-monitoring for patients with severe COPDProcedure or surgery
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
nurse-monitoring for patients with severe COPDProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Treatment as usual |
| Self monitoring for patients with COPD | Experimental | Procedure: self-monitoring for patients with severe COPD Receives: Procedure: self-monitoring for patients with severe COPD |
| Nurse monitoring for patients with COPD | Experimental | Procedure: nurse-monitoring for patients with severe COPD Receives: Procedure: nurse-monitoring for patients with severe COPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-Related quality of life
Health-Related Quality of Life is assessed by the SF-36 questionnaire
Measured: 12 months
Secondary outcomes (6)
Number of bed days for hospitalised patients
Measured: 12 months
Number of specialist visits
Measured: 12 months
Number of visits to emergency department
Measured: 12 months
All cause mortality
Measured: 12 months
Anxiety and depression status
Anxiety and depression status is assessed by Hospital Anxiety and Depression Scale, (HADS).
Measured: 12 months
Number of re-hospitalizations
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study startNov 2011
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regione Veneto
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Massimo Fusello, MD, Principal investigator, Local Health authority Veneziana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01513980
- Sponsor's protocol ID
- G. A. 250487-Veneto WP8Cl5
- Status last verified
- Jan 2012
- First submitted
- 17 Jan 2012
- Last updated
- 17 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
PubMed 27876029
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RENEWING HEALTH - Large Scale Pilot in Veneto Region: Life-long Monitoring in COPD
- ClinicalTrials.gov ID
- NCT01513980
- Acronym / sponsor ID
- G. A. 250487-Veneto WP8Cl5
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Chronic Obstructive Pulmonary Disease, Telemonitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Regione VenetoUniversity, hospital or other
- 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
- Study start
- Nov 2011
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 20 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Treatment as usual |
| Self monitoring for patients with COPD | Experimental | Procedure: self-monitoring for patients with severe COPDProcedure: self-monitoring for patients with severe COPD |
| Nurse monitoring for patients with COPD | Experimental | Procedure: nurse-monitoring for patients with severe COPDProcedure: nurse-monitoring for patients with severe COPD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years.
- COPD GOLD class 3-4
- Life expectance > 12 months
Key exclusion criteria (1 listed)
- Patient unable to use the equipment provided (alone or assisted).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-monitoring for patients with severe COPDPatients 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 | Procedure or surgery | Self monitoring for patients with COPD |
| nurse-monitoring for patients with severe COPDA 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. | Procedure or surgery | Nurse monitoring for patients with COPD |
Primary outcome
Health-Related quality of life
Time frame: 12 months
Health-Related Quality of Life is assessed by the SF-36 questionnaire
6 secondary outcomes
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
Number of re-hospitalizations
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2017.
- Derived from this study: PubMed 27876029Vianello 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.
- 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 CommunityLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Massimo Fusello, MD principal investigator
Local Health authority Veneziana
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-monitoring for patients with severe COPD and nurse-monitoring for patients with severe COPD in people with Pulmonary Disease, Chronic Obstructive, run by Regione Veneto at 6 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-Related quality of life (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01513980, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2017.