CardioBBEAT - Randomized Controled Trial to Evaluate the Health Economic Impact of Remote Patient Monitoring
Gesundheitsökonomische Methodenentwicklung am Beispiel Der Evaluation Einer Technologiebasierten, sektorübergreifenden Intervention Zur Versorgung Chronisch Kranker Patienten
1 other identifier
interventional
621
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 10, 2014
CompletedFirst Posted
Study publicly available on registry
November 18, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedOctober 25, 2016
October 1, 2016
7 years
November 10, 2014
October 24, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
incremental cost effectiveness ratio (ICER)
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 Outcomes (5)
Clinical Outcomes - total mortality
1 year
Clinical Outcome - number of inpatient treatment
1 year
Clinical Outcome - length of stay in hospital or nursing home
1 year
Clinical Outcome - functional state of health
1 year
Clinical Outcome - health related quality of life
1 year
Study Arms (2)
Interventional group
EXPERIMENTALRemote patient monitoring system (Motiva)
Control group
NO INTERVENTIONBest medical treatment according to the guidelines of the European Society of Cardiology (ESC)
Interventions
interactive bi-directional home telemonitoring system that provides remote monitoring
Eligibility Criteria
You may qualify if:
- 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®
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eckhard Nagellead
- German Federal Ministry of Education and Researchcollaborator
Study Sites (1)
University of Bayreuth
Bayreuth, Bavaria, 95444, Germany
Related Publications (2)
Voller H, Bindl D, Nagels K, Hofmann R, Vettorazzi E, Wegscheider K, Fleck E, Stork S, Nagel E. The First Year of Noninvasive Remote Telemonitoring in Chronic Heart Failure Is not Cost Saving but Improves Quality of Life: The Randomized Controlled CardioBBEAT Trial. Telemed J E Health. 2022 Mar 21;28(11):1613-22. doi: 10.1089/tmj.2022.0021. Online ahead of print.
PMID: 35325562DERIVEDHofmann R, Voller H, Nagels K, Bindl D, Vettorazzi E, Dittmar R, Wohlgemuth W, Neumann T, Stork S, Bruder O, Wegscheider K, Nagel E, Fleck E; CardioBBEAT Investigators. First outline and baseline data of a randomized, controlled multicenter trial to evaluate the health economic impact of home telemonitoring in chronic heart failure - CardioBBEAT. Trials. 2015 Aug 11;16:343. doi: 10.1186/s13063-015-0886-8.
PMID: 26259568DERIVED
Related Links
Study Officials
- STUDY CHAIR
Eckhard Nagel, Prof.Dr.mult
Head of Institute for Healthcare Management and Health Science, University of Bayreuth
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof. Dr. Dr. Dr. h.c.
Study Record Dates
First Submitted
November 10, 2014
First Posted
November 18, 2014
Study Start
March 1, 2009
Primary Completion
March 1, 2016
Study Completion
October 1, 2016
Last Updated
October 25, 2016
Record last verified: 2016-10