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The current study aims to investigate whether telemedical monitoring in patients with terminal heart failure and an implanted left ventricular assist device (LVAD) has an influence on LVAD-associated complications, hospitalization rates and quality of life. This is a prospective observational study. Patients with terminal heart failure and an implanted LVAD, where the indication for telemonitoring has already been stated by the attending physician are included in the study. Written informed consent is obtained from all patients. The telemedical monitoring is carried out by the West German Center for Applied Telemedicine (WZAT) and includes a standardized telephone interview every 3 days. In addition, all patients are equipped with an INR measuring device, a body scale and a clinical thermometer by WZAT. The data is documented in an electronic case file (medPower®). In the event of abnormalities, the West German Heart and Vascular Center (WHGZ) is contacted, and all necessary measures are initiated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VAD-patients with Telemonitoring |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| questionnaire (observational study) | Other | questionnaire about hospitalisation rates, complications (bleeding, infection, thrombosis), quality of life (Kansas-Score), depression (PHQ8) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of days spent in the hospital due to VAD-associated complications | VAD-associated complications are defined as
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life from baseline | Quality of life will be assessed with the "Kansas City Cardiomyopathy Questionnaire (KCCQ) " -> The raw values of the domains are transformed to a scale from 0 to 100, where high values indicate good condition. | 6 months |
| Change in depression from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with terminal heart failure and LVAD-therapy who are monitored by telemedicine.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julia Hoffmann | Contact | +49 201 723 85587 | julia.hoffmann@uk-essen.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center, University Hospital Essen | Recruiting | Essen | North Rhine-Westphalia | 45147 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Bundesärztekammer (BÄK) KBK, Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF). Nationale VersorgungsLeitlinie Chronische Herzinsuffizienz - Langfassung, 2. Auflage. Version 3. 2017. | ||
| Background | Bundesauswertung zum Erfassungsjahr 2018: Herzunterstützungssysteme/Kunstherzen; Qualitätsindikatoren und Kennzahlen. IQTIG - Institut für Qualitätssicherung und Transparenz im Gesundheitswesen; 2019 . | ||
| 30034855 | Result | Reiss N, Schmidt T, Boeckelmann M, Schulte-Eistrup S, Hoffmann JD, Feldmann C, Schmitto JD. Telemonitoring of left-ventricular assist device patients-current status and future challenges. J Thorac Dis. 2018 Jun;10(Suppl 15):S1794-S1801. doi: 10.21037/jtd.2018.01.158. | |
| 28752193 |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D019370 | Observation |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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- Depression will be assessed with the "Patient Health Questionnaire eight-item depression scale" (PHQ-8) -> The raw values of the domains are transformed to a scale from 0 to 24, where high values indicate a depression. |
| 6 months |
| Number of VAD-associated complications | VAD-associated complications are defined as
| 6 months |
| Result |
| Kimura M, Nawata K, Kinoshita O, Yamauchi H, Hoshino Y, Hatano M, Amiya E, Kashiwa K, Endo M, Kagami Y, Nemoto M, Ono M. Readmissions after continuous flow left ventricular assist device implantation. J Artif Organs. 2017 Dec;20(4):311-317. doi: 10.1007/s10047-017-0975-4. Epub 2017 Jul 27. |
| 24621797 | Result | Smedira NG, Hoercher KJ, Lima B, Mountis MM, Starling RC, Thuita L, Schmuhl DM, Blackstone EH. Unplanned hospital readmissions after HeartMate II implantation: frequency, risk factors, and impact on resource use and survival. JACC Heart Fail. 2013 Feb;1(1):31-9. doi: 10.1016/j.jchf.2012.11.001. Epub 2013 Feb 4. |
| 31118331 | Result | Reiss N, Wegner KK, Hoffmann JD, Schulte Eistrup S, Boeken U, Morshuis M, Schmidt T. Requirements for a Telemedicine Center to Monitor LVAD Patients. Stud Health Technol Inform. 2019;260:146-153. |
| 26984864 | Result | Bohm M, Drexler H, Oswald H, Rybak K, Bosch R, Butter C, Klein G, Gerritse B, Monteiro J, Israel C, Bimmel D, Kaab S, Huegl B, Brachmann J; OptiLink HF Study Investigators. Fluid status telemedicine alerts for heart failure: a randomized controlled trial. Eur Heart J. 2016 Nov 1;37(41):3154-3163. doi: 10.1093/eurheartj/ehw099. Epub 2016 Mar 16. |
| 25131977 | Result | Hindricks G, Taborsky M, Glikson M, Heinrich U, Schumacher B, Katz A, Brachmann J, Lewalter T, Goette A, Block M, Kautzner J, Sack S, Husser D, Piorkowski C, Sogaard P; IN-TIME study group*. Implant-based multiparameter telemonitoring of patients with heart failure (IN-TIME): a randomised controlled trial. Lancet. 2014 Aug 16;384(9943):583-590. doi: 10.1016/S0140-6736(14)61176-4. |
| 30153985 | Result | Koehler F, Koehler K, Deckwart O, Prescher S, Wegscheider K, Kirwan BA, Winkler S, Vettorazzi E, Bruch L, Oeff M, Zugck C, Doerr G, Naegele H, Stork S, Butter C, Sechtem U, Angermann C, Gola G, Prondzinsky R, Edelmann F, Spethmann S, Schellong SM, Schulze PC, Bauersachs J, Wellge B, Schoebel C, Tajsic M, Dreger H, Anker SD, Stangl K. Efficacy of telemedical interventional management in patients with heart failure (TIM-HF2): a randomised, controlled, parallel-group, unmasked trial. Lancet. 2018 Sep 22;392(10152):1047-1057. doi: 10.1016/S0140-6736(18)31880-4. Epub 2018 Aug 25. |
| 29079934 | Result | Berg T, Tewarie L, Moza A, Zayat R, Autschbach R, Stoppe C, Goetzenich A, Benstoem C. [Requirements for outpatient care after implantation of a ventricular assist device : Views of patients and their relatives]. Herz. 2019 May;44(3):257-264. doi: 10.1007/s00059-017-4636-4. Epub 2017 Oct 27. German. |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D008722 | Methods |