CardioBBEAT - Randomized Controled Trial to Evaluate the Health Economic Impact of Remote Patient Monitoring

October 24, 2016 updated by: Eckhard Nagel

Gesundheitsökonomische Methodenentwicklung am Beispiel Der Evaluation Einer Technologiebasierten, sektorübergreifenden Intervention Zur Versorgung Chronisch Kranker Patienten

The primary endpoint is the incremental cost effectiveness ratio (ICER), defined as the combined clinical endpoint "days alive and not in hospital nor stationary care per days in study" and the change in total cost compared to that of the control group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Between January 2010 and June 2013, 621 patients with left ventricular ejection fraction (LVEF) ≤ 40% were enrolled and randomly assigned to two study arms comprising usual care and a home telemonitoring group. The 302 patients enrolled in the intervention group are supported by an interactive bi-directional home telemonitoring system (Motiva®) that collects and transfers patient's vital sign data to a dedicated telemedicine data centre. All patients were to remain in the study for one year with an examination at the beginning and both, after 6 and 12 months.

Study Type

Interventional

Enrollment (Actual)

621

Phase

  • Not Applicable

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
    • Bayern
      • Bayreuth, Bayern, Germany, 95444
        • University of Bayreuth

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmed diagnosis of Chronic Heart Failure (CHF) based on European Society of Cardiology (ESC) guidelines
  • Symptoms corresponding to New York Heart Association (NYHA) functional class II-IV
  • Left Ventricular Ejection Fraction (LVEF) ≤ 40%
  • American Heart Association (AHA) classification stage C or D
  • Age > 18 years
  • Discharged after hospitalisation for worsening Chronic Heart Failure (CHF) within the last twelve months
  • Able to understand the German language
  • Sufficient eyesight to understand and follow the instructions communicated by the Motiva® platform
  • Willing and able to use the required hard- and software and maintain a patient diary
  • Residing within geographical reach of one of the ten study sites in order to receive additional treatment if required as well as follow-up consultation
  • Willingness to provide informed consent regarding benefits and risks related to the trial, and to sign a participation agreement for the installation of the telemedicine platform Motiva®

Exclusion Criteria:

  • Myocardial infarction within the past four weeks
  • Heart surgery or any coronary intervention within the past eight weeks
  • Cardiogenic shock within the past four weeks
  • Intended cardiac surgery within the next six months or priority status on a waiting list for organ transplantation
  • Severe chronic and pulmonary illness with an immediate impact on the main outcome measures
  • Renal failure requiring dialysis
  • Dementia or other severe cognitive impairment
  • Psychiatric disorders rendering patients unable to participate in the trial
  • Discharged to or living in a geriatric clinic or a nursing home
  • Participation in another clinical trial

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

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional group
Remote patient monitoring system (Motiva)
Device: Remote patient monitoring (Motiva)
interactive bi-directional home telemonitoring system that provides remote monitoring
No Intervention: Control group
Best medical treatment according to the guidelines of the European Society of Cardiology (ESC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incremental cost effectiveness ratio (ICER)
Time Frame: 1 year
consisting of the combined clinical endpoint "days alive and not in hospital nor stationary care per days in study" and the change in total cost
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Outcomes - total mortality
Time Frame: 1 year
total mortality
1 year
Clinical Outcome - number of inpatient treatment
Time Frame: 1 year
number of inpatient treatment
1 year
Clinical Outcome - length of stay in hospital or nursing home
Time Frame: 1 year
length of stay in hospital or nursing home
1 year
Clinical Outcome - functional state of health
Time Frame: 1 year
functional state of health
1 year
Clinical Outcome - health related quality of life
Time Frame: 1 year
health related quality of life
1 year

Collaborators and Investigators

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

Sponsor

Eckhard Nagel

Collaborators

German Federal Ministry of Education and Research

Investigators

  • Study Chair: Eckhard Nagel, Prof.Dr.mult, Head of Institute for Healthcare Management and Health Science, University of Bayreuth

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

Helpful Links

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

March 1, 2009

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

November 10, 2014

First Submitted That Met QC Criteria

November 17, 2014

First Posted (Estimate)

November 18, 2014

Study Record Updates

Last Update Posted (Estimate)

October 25, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01KX0805

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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