Influence of Telemonitoring on the Management of LVAD-patients

Study Overview
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Brief Summary
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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.

Official Title
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Association of Telemonitoring With Hospitalization Rates and Quality of Life in Patients With End-stage Heart Failure and Implanted Left Ventricular Cardiac Assist Devices

Conditions
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Heart Failure, Ventricular Assist Device, Telemedicine

Intervention / Treatment
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* Other: questionnaire (observational study)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age> 18 years Indication for telemedicine Permanently implanted left ventricular assist device (VAD) Exclusion Criteria: no possibility of telephone contact patient does not speak german incompliance rejection or inability to give consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| VAD-patients with Telemonitoring<br> | Other: questionnaire (observational study)<br>* questionnaire about hospitalisation rates, complications (bleeding, infection, thrombosis), quality of life (Kansas-Score), depression (PHQ8)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days spent in the hospital due to VAD-associated complications | VAD-associated complications are defined as bleeding with the need for a transfusion infection with the need for an antibiotic therapy thrombosis with the need for a lysis therapy | 6 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | - 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 bleeding with the need for a transfusion infection with the need for an antibiotic therapy thrombosis with the need for a lysis therapy | 6 months |