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

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ClinicalTrials.gov Identifier: NCT02293252
Recruitment Status : Completed
First Posted : November 18, 2014
Last Update Posted : October 25, 2016
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Eckhard Nagel, University of Bayreuth

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Device: Remote patient monitoring (Motiva) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 621 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Gesundheitsökonomische Methodenentwicklung am Beispiel Der Evaluation Einer Technologiebasierten, sektorübergreifenden Intervention Zur Versorgung Chronisch Kranker Patienten
Study Start Date : March 2009
Actual Primary Completion Date : March 2016
Actual Study Completion Date : October 2016

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)



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02293252


Locations
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Germany
University of Bayreuth
Bayreuth, Bayern, Germany, 95444
Sponsors and Collaborators
Eckhard Nagel
German Federal Ministry of Education and Research
Investigators
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Study Chair: Eckhard Nagel, Prof.Dr.mult Head of Institute for Healthcare Management and Health Science, University of Bayreuth

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eckhard Nagel, Prof. Dr. Dr. Dr. h.c., University of Bayreuth
ClinicalTrials.gov Identifier: NCT02293252     History of Changes
Other Study ID Numbers: 01KX0805
First Posted: November 18, 2014    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016
Keywords provided by Eckhard Nagel, University of Bayreuth:
Home Telemonitoring
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases