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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 |
| Institute of Biomedical Research & Technology, Larissa, Greece | OTHER |
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The purpose of this study is to evaluate whether telemonitoring of patients with chronic heart failure produces a reduction in the combined end point of all cause mortality and number of hospitalisations, and whether it improves health related quality of life. In addition, the trials evaluate the economic and organisational impact of the telemonitoring service and examine its acceptability by patients and health professionals.
The purpose of this study is to the evaluate the use of a mobile and PSTN phone-based telehealth platform will be able to produce a reduction in the combined end point of all cause mortality, will have positive or negative impact in their generic and disease specific quality of life , or their specific activity compared with usual care. Following this; it is also hypothesized that this will also lead to a change in overall risk for CHF complications. In addition the patients' satisfaction using the telemedicine service will be studied. A Cost-Effective Analysis and Cost Utility 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 delivered by their primary care physicians and cardiologists. Usual care consists of regular visits to the specialist or primary care clinics every time a medication change is required, or a medical examination is needed. | |
| Home telemonitoring of patients with CHF | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home telemonitoring of patients with CHF | Procedure | Patients in the intervention group receive a personal 1-lead or 12-lead ECG recorder, a blood pressure monitor, a digital weight scale and appropriate education regarding the use of these devices. ThA trained nurse visits the patients weekly during the first month, and monthly thereafter, to confirm the appropriate use of the devices and services, to monitor symptoms, adherence to pharmacological and non-pharmacological treatment, and to complete the case record forms when necessary. If there is deterioration in the monitored vital signs, or if symptoms are reported, the allocated cardiologist is informed via the telehealth platform and has to decide whether the patient has to visit the hospital as in- or outpatient and whether the therapy has to be modified. |
| Measure | Description | Time Frame |
|---|---|---|
| Combined end point of all cause mortality | 12 months minimum | |
| Number of hospitalisations for heart failure | 12 months minimum |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular and all-cause mortality | 12 months minimum | |
| Health related quality of life as measured by the SF-36 v2 | 12 months minimum- at the entry point of the intervention and the end | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Filippos Triposkiadis, MD, PhD | Cardiology Department - Regional University Hospital of Larisa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology Department - Regional University Hospital of Larisa | Larissa | Thessaly | 41110 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19687005 | Background | Scherr D, Kastner P, Kollmann A, Hallas A, Auer J, Krappinger H, Schuchlenz H, Stark G, Grander W, Jakl G, Schreier G, Fruhwald FM; MOBITEL Investigators. Effect of home-based telemonitoring using mobile phone technology on the outcome of heart failure patients after an episode of acute decompensation: randomized controlled trial. J Med Internet Res. 2009 Aug 17;11(3):e34. doi: 10.2196/jmir.1252. | |
| 17426062 |
| 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 |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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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|
| Patient's specific activity using Specific activity questionnaire (SAQ) and the Veterans specific activity questionnaire (VSAQ) |
| 12 months minimum- at the entry point of the intervention and the end. |
| Disease Specific Quality of Life using the Minnesota Living with Heart Failure questionnaire (MLHF) | 12 months minimum- at the entry point of the intervention and the end. |
| Economic Evaluation (Cost-Effective Analysis- Cost Utility Analysis) | 12 months minimum |
| Patients' Acceptance-Satisfaction measured by the WSD Questionnaire | at 2nd and at 12th month |
| Background |
| Clark RA, Inglis SC, McAlister FA, Cleland JG, Stewart S. Telemonitoring or structured telephone support programmes for patients with chronic heart failure: systematic review and meta-analysis. BMJ. 2007 May 5;334(7600):942. doi: 10.1136/bmj.39156.536968.55. Epub 2007 Apr 10. |
| 15893183 | Background | Cleland JG, Louis AA, Rigby AS, Janssens U, Balk AH; TEN-HMS Investigators. Noninvasive home telemonitoring for patients with heart failure at high risk of recurrent admission and death: the Trans-European Network-Home-Care Management System (TEN-HMS) study. J Am Coll Cardiol. 2005 May 17;45(10):1654-64. doi: 10.1016/j.jacc.2005.01.050. Epub 2005 Apr 22. |
| 19850208 | Background | Klersy C, De Silvestri A, Gabutti G, Regoli F, Auricchio A. A meta-analysis of remote monitoring of heart failure patients. J Am Coll Cardiol. 2009 Oct 27;54(18):1683-94. doi: 10.1016/j.jacc.2009.08.017. |
| 20687083 | Background | Inglis SC, Clark RA, McAlister FA, Ball J, Lewinter C, Cullington D, Stewart S, Cleland JG. Structured telephone support or telemonitoring programmes for patients with chronic heart failure. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD007228. doi: 10.1002/14651858.CD007228.pub2. |
| 21733889 | Background | Inglis SC, Clark RA, McAlister FA, Stewart S, Cleland JG. Which components of heart failure programmes are effective? A systematic review and meta-analysis of the outcomes of structured telephone support or telemonitoring as the primary component of chronic heart failure management in 8323 patients: Abridged Cochrane Review. Eur J Heart Fail. 2011 Sep;13(9):1028-40. doi: 10.1093/eurjhf/hfr039. Epub 2011 Jul 6. |
| 21080835 | Background | Chaudhry SI, Mattera JA, Curtis JP, Spertus JA, Herrin J, Lin Z, Phillips CO, Hodshon BV, Cooper LS, Krumholz HM. Telemonitoring in patients with heart failure. N Engl J Med. 2010 Dec 9;363(24):2301-9. doi: 10.1056/NEJMoa1010029. Epub 2010 Nov 16. |