Influence of Telemonitoring on the Management of LVAD-patients

• Conditions: Heart Failure; Ventricular Assist Device; Telemedicine
• Interventions: Other: questionnaire (observational study)

• Registration Number: NCT04613401
• Lead Sponsor: University Hospital, Essen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2020-10-26
• Status Verified: 2020-11
• Study First Submitted QC: 2020-11-02
• Last Update Submitted: 2020-11-02
• Study First Posted: 2020-11-03
• Last Update Posted: 2020-11-03
• Primary Completion: 2021-07
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
VAD-patients with Telemonitoring	questionnaire (observational study)	-

Primary Outcome Measures

Name	Time	Method
Number of days spent in the hospital due to VAD-associated complications	6 months	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

Secondary Outcome Measures

Name	Time	Method
Change in quality of life from baseline	6 months	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.
Change in depression from baseline	6 months	- 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.
Number of VAD-associated complications	6 months	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

Trial Locations

Locations (1)

Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center, University Hospital Essen; 🇩🇪 Essen, NRW, Germany