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Completed

NCT Number: NCT02293252

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

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.

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Key information

Conditions

Chronic Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bayreuth

Bayreuth, Bavaria, 95444, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remote patient monitoring (Motiva)

Device

interactive bi-directional home telemonitoring system that provides remote monitoring

Primary outcomes

  1. 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

Secondary outcomes

  1. Clinical Outcomes - total mortality

    Time frame: 1 year

    total mortality

  2. Clinical Outcome - number of inpatient treatment

    Time frame: 1 year

    number of inpatient treatment

  3. Clinical Outcome - length of stay in hospital or nursing home

    Time frame: 1 year

    length of stay in hospital or nursing home

  4. Clinical Outcome - functional state of health

    Time frame: 1 year

    functional state of health

  5. Clinical Outcome - health related quality of life

    Time frame: 1 year

    health related quality of life

Sponsors and collaborators

Lead sponsor

Eckhard Nagel

Other

Collaborators

  • German Federal Ministry of Education and Research

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Nov 18, 2014
Registry last updated
Oct 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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