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| Name | Class |
|---|---|
| European Commission | OTHER |
| Azienda Unità Locale Socio Sanitaria n.9 Treviso | OTHER |
| Azienda ULSS 12 Veneziana | OTHER |
| Azienda ULSS di Verona e Provincia |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Treatment as usual | |
| Self monitoring for patients with COPD | Experimental | Procedure: self-monitoring for patients with severe COPD |
|
| Nurse monitoring for patients with COPD | Experimental | Procedure: nurse-monitoring for patients with severe COPD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| self-monitoring for patients with severe COPD | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Health-Related quality of life | Health-Related Quality of Life is assessed by the SF-36 questionnaire | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of bed days for hospitalised patients | 12 months | |
| Number of specialist visits | 12 months | |
| Number of visits to emergency department |
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Inclusion Criteria:
Exclusion Criteria:
• Patient unable to use the equipment provided (alone or assisted).
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| Name | Affiliation | Role |
|---|---|---|
| Massimo Fusello, MD | Local Health authority Veneziana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Health Autority n.16 Padova - Pulmonology outpatient clinic | Padova | Padova | 35127 | Italy | ||
| Hospital Trust of Padova - Respiratory Physiopathology Department |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27876029 | Derived | 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. |
| Label | URL |
|---|---|
| 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 | View source |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| OTHER |
| Azienda ULSS 16 Padova | OTHER |
| Azienda Ospedaliera di Padova | OTHER |
| Azienda Ospedaliera Universitaria Integrata Verona | OTHER |
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|
| nurse-monitoring for patients with severe COPD | Procedure | 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. |
|
| 12 months |
| All cause mortality | 12 months |
| Anxiety and depression status | Anxiety and depression status is assessed by Hospital Anxiety and Depression Scale, (HADS). | 12 months |
| Number of re-hospitalizations | 12 months |
| Padova |
| Padova |
| 35128 |
| Italy |
| Ospedale Ca'Foncello - Pulmonology Department | Treviso | Treviso | 31100 | Italy |
| Ospedale dell'Angelo - Pulmonology Department | Mestre | Venezia | 30174 | Italy |
| Ospedale di Marzana - Rehabilitative respiratory unit | Marzana | Verona | 37034 | Italy |
| Hospital Trust of Verona - Pneumonology Department | Verona | Verona | 37124 | Italy |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |