Influence of Telemonitoring on the Management of LVAD-patients

November 2, 2020 updated by: University Hospital, Essen

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Essen, NRW, Germany, 45147
        • Recruiting
        • Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center, University Hospital Essen
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with terminal heart failure and LVAD-therapy who are monitored by telemedicine.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
VAD-patients with Telemonitoring
Other: questionnaire (observational study)
questionnaire about hospitalisation rates, complications (bleeding, infection, thrombosis), quality of life (Kansas-Score), depression (PHQ8)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of days spent in the hospital due to VAD-associated complications
Time Frame: 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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in quality of life from baseline
Time Frame: 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.
6 months
Change in depression from baseline
Time Frame: 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.
6 months
Number of VAD-associated complications
Time Frame: 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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Essen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2020

Primary Completion (ANTICIPATED)

July 1, 2021

Study Completion (ANTICIPATED)

December 1, 2021

Study Registration Dates

First Submitted

October 26, 2020

First Submitted That Met QC Criteria

November 2, 2020

First Posted (ACTUAL)

November 3, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 3, 2020

Last Update Submitted That Met QC Criteria

November 2, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-9312-BO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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