Heart FailureCardioCoachNCT03294811
A Two-way Communication System to Coach Elderly Patients With Heart Failure
A study testing Telemonitoring in people with Heart Failure, run by Hasselt University at 2 sites in Belgium.
Trial summary
This is an open randomized clinical trial with two study arms. One group, receiving usual care for heart failure, will be compared to another group, receiving usual care plus active telemonitoring interference. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Telemonitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 May 2014to 4 Apr 2018
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 60
- Patient has to be followed in Ziekenhuis Oost-Limburg or Jessa Ziekenhuis Hasselt and has to live in the region Genk - Hasselt
- The patient has to be cognitive strong enough and speak enough Dutch to communicate about their health situation and to understand the smartphone application
- The diagnosis of systolic heart failure or severe myocardial infarction has to be done during consultation or hospitalization
- Left ventricular ejection fraction (LVEF) <45%
- Treatment minimally with ACE-I and BB On the basis of an interview between the heart failure nurse and patient, one will decide if the patient is eligible to join the study. The patient also needs to speak sufficient Dutch to be communicative about his/her medical condition.
Who cannot join
- Reversible form of heart failure
- Heart failure due to severe aortic stenosis
- At the time of inclusion a eGFR less than 30ml/min/kg
- Presence of a cardiac resynchronization therapy (CRT) device
- Active treatment with either ACE-I/ARB or BB
- Patient that are subscribed in a cardiac revalidation program when leaving the hospital
- Patients with severe form of COPD (GOLD III)
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Ziekenhuis Oost-Limburg
Genk, 3600
Jessa Ziekenhuis
Hasselt, 3500
About this study
Official title: CARDIOCOACH: Development of an Intelligent Two-way Communication System to Coach Elderly Patients With Heart Failure in Their Home Situation
This is an open randomized clinical trial with two study arms. One group, receiving usual care for heart failure, will be compared to another group, receiving usual care plus active telemonitoring interference.
When leaving the hospital, the usual care arm receives a document with a predefined medication scheme and advice for the general practitioner (like it is currently done in usual care).
The telemonitoring interference in the other study arm consists of a smartphone application to register medication intake and to transmit the data of an automatic blood pressure device and a balance to a central platform. The goal is to improve medication uptitration (angiotensin-converting-enzyme inhibitor (ACE-I) and bètablockers (BB)) in heart failure patients and to improve medication compliance.
- Conditions
- Heart Failure
- Being tested
- Telemonitoring
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemonitoringDevice
Also called Telemedicine, remote monitoring, remote follow-up
The telemonitoring interference in the telemonitoring arm consists of a smartphone application that helps the patient to take their medication in time and to take their blood pressure and weight on a daily basis in order to improve the medication uptitration and medication compliance.
| Study group | Role | What they receive |
|---|---|---|
| Telemonitoring group | Experimental | Recieve a smartphone with an application to coach them, a blood pressure monitor and scale. Receives: Device: Telemonitoring |
| Control group | No intervention | Control group (usual care, without telemonitoring) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean medication doses
Mean daily doses of ACE-inhibitors/ARB's, β blokkers and Aldosteron antagonists after 3 months. This is estimated by registration of the types of medication, the corresponding doses and the frequency of intake.
Measured: 3 months
Secondary outcomes (10)
Medication titration
Mean daily doses of ACE-inhibitors/ARB's, β blokkers and Aldosteron antagonists after 6 months. This is estimated by registration of the types of medication, the corresponding doses and the frequency of intake.
Measured: after month 6
All-cause mortality
All-cause mortality
Measured: up to month 6
All cardio related hospitalizations (number and time)
- Arrythmogenic nature
- Ischemic nature
- Heart failure nature
- Valvular/surgical nature
- Elektrofysiological nature (implantation ICD, CRT,…)
Measured: up to month 6
All heart failure hospitalizations
- Treatment with (whether or not intravenous) diuretic therapy
- Treatment with hemodynamic guided therapy (vasodilators)
- Treatment with intravenous inotropics
Measured: up to month 6
Number of medical practitioner-patient contacts
- In hospital (medical record)
- General practitioner
- At patient home (Remedus)
Measured: up to month 6
Number of (telephone) contacts, registered by the heart failure nurse
Number of (telephone) contacts, registered by the heart failure nurse
Measured: up to month 6
Number of (telephone) contacts for the encouragement of medication compliance and parameter (Remedus)
Number of (telephone) contacts for the encouragement of medication compliance (Remedus)
Measured: up to month 6
Evolution of heart failure and comorbidities
- Blood collection with: kidney function determinations, electrolytes
- Echo parameters (cardiac output, LVEF, diameters end systolic and diastolic)
- Weight, length, blood pressure, ECG
Measured: up to month 6
Quality of life according to the HeartQoL questionnaire
Quality of life according to the HeartQoL questionnaire
Measured: day 1, month 6
Satisfaction survey
Satisfaction survey about the received care (anonymous) for the cardiocoach group.
Measured: month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2017
- Study start1 May 2014
- Primary completion15 Dec 2016
- Study completion4 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg, Jessa Hospital
- Responsible party
- Principal investigator, Pieter Vandervoort, Hasselt University
- Investigators
- Vandervoort Pieter, MD, PhD, Study director, Ziekenhuis Oost-LimburgPaul Dendale, MD, PhD, Study director, Jessa Ziekenhuis, Hasselt, BelgiumJo Ravelingen, Study director, Remedus, Aartselaar, BelgiumPeter Van Vooren, Study director, Fifthplay, Antwerpen, BelgiumValerie Storms, PhD, Study director, Mobile Health Unit, Hasselt University, Hasselt, BelgiumLars Grieten, PhD, Principal investigator, Mobile Health Unit, Hasselt University, Hasselt, BelgiumChristophe Smeets, PhD student, Study chair, Mobile Health Unit, Hasselt University, Hasselt, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03294811
- Sponsor's protocol ID
- Cardiocoach
- Acronym
- CardioCoach
- Status last verified
- May 2019
- First submitted
- 20 May 2014
- Last updated
- 13 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Smeets CJ, Storms V, Vandervoort PM, Dreesen P, Vranken J, Houbrechts M, Goris H, Grieten L, Dendale P. A Novel Intelligent Two-Way Communication System for Remote Heart Failure Medication Uptitration (the CardioCoach Study): Randomized Controlled Feasibility Trial. JMIR Cardio. 2018 Apr 4;2(1):e8. doi: 10.2196/cardio.9153.
PubMed 31758773
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CARDIOCOACH: Development of an Intelligent Two-way Communication System to Coach Elderly Patients With Heart Failure in Their Home Situation
- ClinicalTrials.gov ID
- NCT03294811
- Acronym / sponsor ID
- CardioCoach / Cardiocoach
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg, Jessa Hospital
- Study start
- 1 May 2014 (actual)
- Primary completion
- 15 Dec 2016 (actual)
- Study completion
- 4 Apr 2018 (actual)
- First posted
- 27 Sep 2017 (actual)
- 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.
This is an open randomized clinical trial with two study arms. One group, receiving usual care for heart failure, will be compared to another group, receiving usual care plus active telemonitoring interference.
When leaving the hospital, the usual care arm receives a document with a predefined medication scheme and advice for the general practitioner (like it is currently done in usual care).
The telemonitoring interference in the other study arm consists of a smartphone application to register medication intake and to transmit the data of an automatic blood pressure device and a balance to a central platform. The goal is to improve medication uptitration (angiotensin-converting-enzyme inhibitor (ACE-I) and bètablockers (BB)) in heart failure patients and to improve medication compliance.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemonitoring group | Experimental | Device: TelemonitoringRecieve a smartphone with an application to coach them, a blood pressure monitor and scale. |
| Control group | No intervention | –Control group (usual care, without telemonitoring) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 60
- Patient has to be followed in Ziekenhuis Oost-Limburg or Jessa Ziekenhuis Hasselt and has to live in the region Genk - Hasselt
- The patient has to be cognitive strong enough and speak enough Dutch to communicate about their health situation and to understand the smartphone application
- The diagnosis of systolic heart failure or severe myocardial infarction has to be done during consultation or hospitalization
- Left ventricular ejection fraction (LVEF) <45%
Key exclusion criteria (7 listed)
- Reversible form of heart failure
- Heart failure due to severe aortic stenosis
- At the time of inclusion a eGFR less than 30ml/min/kg
- Presence of a cardiac resynchronization therapy (CRT) device
- Active treatment with either ACE-I/ARB or BB
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 |
|---|---|---|
| TelemonitoringAlso: Telemedicine, remote monitoring, remote follow-upThe telemonitoring interference in the telemonitoring arm consists of a smartphone application that helps the patient to take their medication in time and to take their blood pressure and weight on a daily basis in order to improve the medication uptitration and medication compliance. | Device | Telemonitoring group |
Primary outcome
Mean medication doses
Time frame: 3 months
Mean daily doses of ACE-inhibitors/ARB's, β blokkers and Aldosteron antagonists after 3 months. This is estimated by registration of the types of medication, the corresponding doses and the frequency of intake.
10 secondary outcomes
Medication titration
Time frame: after month 6
All-cause mortality
Time frame: up to month 6
All cardio related hospitalizations (number and time)
Time frame: up to month 6
All heart failure hospitalizations
Time frame: up to month 6
Number of medical practitioner-patient contacts
Time frame: up to month 6
Number of (telephone) contacts, registered by the heart failure nurse
Time frame: up to month 6
Number of (telephone) contacts for the encouragement of medication compliance and parameter (Remedus)
Time frame: up to month 6
Evolution of heart failure and comorbidities
Time frame: up to month 6
Quality of life according to the HeartQoL questionnaire
Time frame: day 1, month 6
Satisfaction survey
Time frame: month 6
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 13 May 2019.
- Derived from this study: PubMed 31758773Smeets CJ, Storms V, Vandervoort PM, Dreesen P, Vranken J, Houbrechts M, Goris H, Grieten L, Dendale P. A Novel Intelligent Two-Way Communication System for Remote Heart Failure Medication Uptitration (the CardioCoach Study): Randomized Controlled Feasibility Trial. JMIR Cardio. 2018 Apr 4;2(1):e8. doi: 10.2196/cardio.9153.
- Individual participant dataSharing planned: Undecided
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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.
Vandervoort Pieter, MD, PhD study director
Ziekenhuis Oost-Limburg
Paul Dendale, MD, PhD study director
Jessa Ziekenhuis, Hasselt, Belgium
Jo Ravelingen study director
Remedus, Aartselaar, Belgium
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemonitoring in people with Heart Failure, run by Hasselt University at 2 sites in Belgium.
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 6 inclusion and 7 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 13 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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?
Mean medication doses (time frame: 3 months). 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 NCT03294811, which also lists 1 linked publication.
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 13 May 2019.