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| ID | Type | Description | Link |
|---|---|---|---|
| EC Grant Agreement 250487 | Other Grant/Funding Number | European Commission CIP/PSP-ICT Grant Agreement 250487 |
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| Name | Class |
|---|---|
| Ministry for Health and Social Solidarity, Greece | OTHER |
| Municipality of Trikala, Greece | OTHER |
| e-Trikala S.A. | INDUSTRY |
| Cities Net SA |
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The purpose of this study is to evaluate whether the introduction of a short-term telemonitoring program for chronic obstructive pulmonary disease (COPD) patients discharged from the hospital after disease exacerbation produces benefits in terms of a reduction in hospital readmissions and health related quality of life. In addition the trials evaluate the economical and organisational impact of the services and examine their acceptability by patients and health professionals.
The purpose of this study is to the evaluate the use of a close phone-based tele-monitoring platform will reflected by less hospital re-admissions, will change their generic and disease specific quality of life compared with usual care. Following this; it is also hypothesized that this will also lead to less patients' deaths. In addition the patients' satisfaction using the telemedicine service will be studied. A Cost-Effective Analysis will evaluate the tele-health service compared with the usual care from the health and social perspective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | No Intervention | Patients in the control group receive usual care and visit the outpatient department at 4 and at 12 weeks after discharge when pulse rate, oxygen saturation and spirometry is performed. In the case of clinical deterioration during the study, the patients contact as usual their general practitioner. Usual care of COPD patients consists of regular visits to the specialist or primary care clinics every time a medication change is made or a medical examination is needed | |
| Telemonitoring | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemonitoring | Procedure | Within 24 hours after patient's discharge, the telemedicine equipment is installed at the patient's home and patients are trained in the use of the equipment. Patients are followed by a dedicated telehealth centre. Patients at home are asked to fill out each morning the CAT questionnaire and to record extra use of COPD relief medications. Patients in stable conditions perform telespirometry and teleoximetry at 4 and 12 weeks. When a clinical worsening is detected (increase in CAT score by 5 points or higher on two consecutive days) the patient is contacted and asked to perform ad hoc telespirometry and teleoximetry and to send the data to the telehealth centre. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of hospital readmissions | Number of hospital readmissions after the hospital discharged of the patient after a COPD exacerbation | 3 months period |
| Measure | Description | Time Frame |
|---|---|---|
| Health related quality of life of the patients as measured by the SF-36 version 2 questionnaire | Health related quality of life of the patients as measured by the SF-36 version 2 questionnaire | 3 months - at the entry point of the intervention and the end. |
| Hospital anxiety and depression scale HADS |
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Inclusion Criteria:
Exclusion Criteria:
included in previous COPD monitoring study
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| Name | Affiliation | Role |
|---|---|---|
| Konstantinos Gourgoulianis, MD, PhD | Pulmonary Department - University Hospital of Larisa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pulmonary Department - Regional University Hospital of Larisa | Larissa | Thessaly | 41110 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20197355 | Background | Polisena J, Tran K, Cimon K, Hutton B, McGill S, Palmer K, Scott RE. Home telehealth for chronic obstructive pulmonary disease: a systematic review and meta-analysis. J Telemed Telecare. 2010;16(3):120-7. doi: 10.1258/jtt.2009.090812. Epub 2010 Mar 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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| INDUSTRY |
| Institute of Biomedical Research & Technology, Larissa, Greece | OTHER |
| Institute of Communications and Computer Systems, Athens, Greece | OTHER |
| Alexander Technological Educational Institute, Thessaloniki, Greece | OTHER |
| University of Macedonia, Thessaloniki, Greece | OTHER |
| University of Thessaly | OTHER |
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|
Hospital anxiety and depression scale HADS |
| 3 months - at the entry point of the intervention and the end. |
| Health status, measured with the St. George's Respiratory Questionnaire SGRQ | Health status, measured with the St. George's Respiratory Questionnaire SGRQ | 3 months - at the entry point of the intervention and the end. |
| Lung condition as measured by FEV1 | Lung condition as measured by FEV1 | 1 month after the hospital discharge. |
| Mortality | Mortality | 3 months period |
| Patients' Acceptance-Satisfaction measured by the WSD Questionnaire | Patients' Acceptance-Satisfaction of telemonitoring measured by the Whole System Demonstrators Questionnaire , for the intervention arm (telemonitoring) | at the 3rd month of the tele-monitoring |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |