Influence of Telemonitoring on the Management of LVAD-patients

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04613401
• Other study ID #: 20-9312-BO
• Status: Recruiting
• Start date: July 1, 2020
• Est. completion date: December 2021

Study information

• Verified date: November 2020
• Source: University Hospital, Essen
• Contact: Julia Hoffmann
• Phone: +49 201 723 85587
• Email: julia.hoffmann[@]uk-essen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Telemedicine
• Ventricular Assist Device

Intervention

Other:
• questionnaire (observational study)
questionnaire about hospitalisation rates, complications (bleeding, infection, thrombosis), quality of life (Kansas-Score), depression (PHQ8)

Locations

Country	Name	City	State
Germany	Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center, University Hospital Essen	Essen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Essen

Country where clinical trial is conducted

Germany, 

References & Publications (10)

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/ — View Citation

Böhm M, Drexler H, Oswald H, Rybak K, Bosch R, Butter C, Klein G, Gerritse B, Monteiro J, Israel C, Bimmel D, Käab S, Huegl B, Brachmann J; OptiLink HF Study Investigators. Fluid status telemedicine alerts for heart failure: a randomized controlled trial. — View Citation

Bundesärztekammer (BÄK) KBK, Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF). Nationale VersorgungsLeitlinie Chronische Herzinsuffizienz - Langfassung, 2. Auflage. Version 3. 2017.

Bundesauswertung zum Erfassungsjahr 2018: Herzunterstützungssysteme/Kunstherzen; Qualitätsindikatoren und Kennzahlen. IQTIG - Institut für Qualitätssicherung und Transparenz im Gesundheitswesen; 2019 .

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, Søgaard P; IN-TIME study group*. Implant-based multiparameter telemonitoring of patients with hea — View Citation

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/s — View Citation

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, Störk S, Butter C, Sechtem U, Angermann C, Gola G, Prondzinsky R, Edelmann F, Spethmann S, Schellong SM, Schulze — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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