Back to resultsCardioBBEAT - Randomized Controled Trial to Evaluate the Health Economic Impact of Remote Patient Monitoring
Primary Purpose
Chronic Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Remote patient monitoring (Motiva)
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Heart Failure focused on measuring Home Telemonitoring
Eligibility 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
Sites / Locations
- University of Bayreuth
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Interventional group
Control group
Arm Description
Remote patient monitoring system (Motiva)
Best medical treatment according to the guidelines of the European Society of Cardiology (ESC)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Clinical Outcomes - total mortality
total mortality
Clinical Outcome - number of inpatient treatment
number of inpatient treatment
Clinical Outcome - length of stay in hospital or nursing home
length of stay in hospital or nursing home
Clinical Outcome - functional state of health
functional state of health
Clinical Outcome - health related quality of life
health related quality of life
Full Information
NCT ID
NCT02293252
First Posted
November 10, 2014
Last Updated
October 24, 2016
Sponsor
Eckhard Nagel
Collaborators
German Federal Ministry of Education and Research
1. Study Identification
Unique Protocol Identification Number
NCT02293252
Brief Title
CardioBBEAT - Randomized Controled Trial to Evaluate the Health Economic Impact of Remote Patient Monitoring
Official Title
Gesundheitsökonomische Methodenentwicklung am Beispiel Der Evaluation Einer Technologiebasierten, sektorübergreifenden Intervention Zur Versorgung Chronisch Kranker Patienten
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eckhard Nagel
Collaborators
German Federal Ministry of Education and Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
Home Telemonitoring
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
621 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interventional group
Arm Type
Experimental
Arm Description
Remote patient monitoring system (Motiva)
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Best medical treatment according to the guidelines of the European Society of Cardiology (ESC)
Intervention Type
Device
Intervention Name(s)
Remote patient monitoring (Motiva)
Intervention Description
interactive bi-directional home telemonitoring system that provides remote monitoring
Primary Outcome Measure Information:
Title
incremental cost effectiveness ratio (ICER)
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Clinical Outcomes - total mortality
Description
total mortality
Time Frame
1 year
Title
Clinical Outcome - number of inpatient treatment
Description
number of inpatient treatment
Time Frame
1 year
Title
Clinical Outcome - length of stay in hospital or nursing home
Description
length of stay in hospital or nursing home
Time Frame
1 year
Title
Clinical Outcome - functional state of health
Description
functional state of health
Time Frame
1 year
Title
Clinical Outcome - health related quality of life
Description
health related quality of life
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eckhard Nagel, Prof.Dr.mult
Organizational Affiliation
Head of Institute for Healthcare Management and Health Science, University of Bayreuth
Official's Role
Study Chair
Facility Information:
Facility Name
University of Bayreuth
City
Bayreuth
State/Province
Bayern
ZIP/Postal Code
95444
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
35325562
Citation
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.
Results Reference
derived
PubMed Identifier
26259568
Citation
Hofmann 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.
Results Reference
derived
Links:
URL
http://www.trialsjournal.com/content/16/1/343
Description
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
Learn more about this trial
CardioBBEAT - Randomized Controled Trial to Evaluate the Health Economic Impact of Remote Patient Monitoring
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