Chronic Heart FailureNCT02293252
CardioBBEAT - Randomized Controled Trial to Evaluate the Health Economic Impact of Remote Patient Monitoring
A study testing Remote patient monitoring (Motiva) in people with Chronic Heart Failure, run by Eckhard Nagel at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Remote patient monitoring (Motiva)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 621 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2009to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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®
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Heart Failure
- Being tested
- Remote patient monitoring (Motiva)
- Keywords
- Home Telemonitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote patient monitoring (Motiva)Device
interactive bi-directional home telemonitoring system that provides remote monitoring
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | Remote patient monitoring system (Motiva) Receives: Device: Remote patient monitoring (Motiva) |
| Control group | No intervention | Best medical treatment according to the guidelines of the European Society of Cardiology (ESC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (5)
Clinical Outcomes - total mortality
total mortality
Measured: 1 year
Clinical Outcome - number of inpatient treatment
number of inpatient treatment
Measured: 1 year
Clinical Outcome - length of stay in hospital or nursing home
length of stay in hospital or nursing home
Measured: 1 year
Clinical Outcome - functional state of health
functional state of health
Measured: 1 year
Clinical Outcome - health related quality of life
health related quality of life
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2014 (estimated)
- Study startMar 2009
- Primary completionMar 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 621 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eckhard Nagel
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Sponsor-investigator, Eckhard Nagel, University of Bayreuth
- Investigators
- Eckhard Nagel, Prof.Dr.mult, Study chair, Head of Institute for Healthcare Management and Health Science, University of Bayreuth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02293252
- Sponsor's protocol ID
- 01KX0805
- Status last verified
- Oct 2016
- First submitted
- 10 Nov 2014
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 35325562Hofmann 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.
PubMed 26259568
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gesundheitsökonomische Methodenentwicklung am Beispiel Der Evaluation Einer Technologiebasierten, sektorübergreifenden Intervention Zur Versorgung Chronisch Kranker Patienten
- ClinicalTrials.gov ID
- NCT02293252
- Acronym / sponsor ID
- 01KX0805
- Conditions
- Chronic Heart Failure
- Keywords
- Home Telemonitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 621 participants (actual)
- Lead sponsor
- Eckhard NagelUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Mar 2009
- Primary completion
- Mar 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 18 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Device: Remote patient monitoring (Motiva)Remote patient monitoring system (Motiva) |
| Control group | No intervention | –Best medical treatment according to the guidelines of the European Society of Cardiology (ESC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote patient monitoring (Motiva)interactive bi-directional home telemonitoring system that provides remote monitoring | Device | Interventional group |
Primary outcome
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
5 secondary outcomes
Clinical Outcomes - total mortality
Time frame: 1 year
Clinical Outcome - number of inpatient treatment
Time frame: 1 year
Clinical Outcome - length of stay in hospital or nursing home
Time frame: 1 year
Clinical Outcome - functional state of health
Time frame: 1 year
Clinical Outcome - health related quality of life
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- Derived from this study: PubMed 35325562Voller 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.
- Derived from this study: PubMed 26259568Hofmann 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.
- First outline and baseline data of a randomized, controlled multicenter trial to evaluate the health economic impact of home telemonitoring in chronic heart failure - CardioBBEATLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eckhard Nagel, Prof.Dr.mult study chair
Head of Institute for Healthcare Management and Health Science, University of Bayreuth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote patient monitoring (Motiva) in people with Chronic Heart Failure, run by Eckhard Nagel at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incremental cost effectiveness ratio (ICER) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02293252, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2016.