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| Name | Class |
|---|---|
| German Federal Ministry of Education and Research | OTHER_GOV |
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The primary endpoint is the incremental cost effectiveness ratio (ICER), defined as the combined clinical endpoint "days alive and not in hospital nor stationary care per days in study" and the change in total cost compared to that of the control group.
Between January 2010 and June 2013, 621 patients with left ventricular ejection fraction (LVEF) ≤ 40% were enrolled and randomly assigned to two study arms comprising usual care and a home telemonitoring group. The 302 patients enrolled in the intervention group are supported by an interactive bi-directional home telemonitoring system (Motiva®) that collects and transfers patient's vital sign data to a dedicated telemedicine data centre. All patients were to remain in the study for one year with an examination at the beginning and both, after 6 and 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional group | Experimental | Remote patient monitoring system (Motiva) |
|
| Control group | No Intervention | Best medical treatment according to the guidelines of the European Society of Cardiology (ESC) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote patient monitoring (Motiva) | Device | interactive bi-directional home telemonitoring system that provides remote monitoring |
|
| Measure | Description | Time Frame |
|---|---|---|
| incremental cost effectiveness ratio (ICER) | consisting of the combined clinical endpoint "days alive and not in hospital nor stationary care per days in study" and the change in total cost | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Outcomes - total mortality | total mortality | 1 year |
| Clinical Outcome - number of inpatient treatment | number of inpatient treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eckhard Nagel, Prof.Dr.mult | Head of Institute for Healthcare Management and Health Science, University of Bayreuth | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Bayreuth | Bayreuth | Bavaria | 95444 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35325562 | Derived | Voller H, Bindl D, Nagels K, Hofmann R, Vettorazzi E, Wegscheider K, Fleck E, Stork S, Nagel E. The First Year of Noninvasive Remote Telemonitoring in Chronic Heart Failure Is not Cost Saving but Improves Quality of Life: The Randomized Controlled CardioBBEAT Trial. Telemed J E Health. 2022 Mar 21;28(11):1613-22. doi: 10.1089/tmj.2022.0021. Online ahead of print. | |
| 26259568 |
| Label | URL |
|---|---|
| First outline and baseline data of a randomized, controlled multicenter trial to evaluate the health economic impact of home telemonitoring in chronic heart failure - CardioBBEAT | View source |
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| 1 year |
| Clinical Outcome - length of stay in hospital or nursing home | length of stay in hospital or nursing home | 1 year |
| Clinical Outcome - functional state of health | functional state of health | 1 year |
| Clinical Outcome - health related quality of life | health related quality of life | 1 year |
| Hofmann R, Voller H, Nagels K, Bindl D, Vettorazzi E, Dittmar R, Wohlgemuth W, Neumann T, Stork S, Bruder O, Wegscheider K, Nagel E, Fleck E; CardioBBEAT Investigators. First outline and baseline data of a randomized, controlled multicenter trial to evaluate the health economic impact of home telemonitoring in chronic heart failure - CardioBBEAT. Trials. 2015 Aug 11;16:343. doi: 10.1186/s13063-015-0886-8. |