A Two-way Communication System to Coach Elderly Patients With Heart Failure (CardioCoach)

May 10, 2019 updated by: Pieter Vandervoort, Hasselt University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Genk, Belgium, 3600
        • Ziekenhuis Oost-Limburg
      • Hasselt, Belgium, 3500
        • Jessa ziekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Telemonitoring group
Recieve a smartphone with an application to coach them, a blood pressure monitor and scale.
Device: Telemonitoring
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.
Other Names:
  • Telemedicine
  • remote monitoring
  • remote follow-up
No Intervention: Control group
Control group (usual care, without telemonitoring)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Medication titration
Time Frame: after month 6
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.
after month 6
All-cause mortality
Time Frame: up to month 6
All-cause mortality
up to month 6
All cardio related hospitalizations (number and time)
Time Frame: up to month 6
  • Arrythmogenic nature
  • Ischemic nature
  • Heart failure nature
  • Valvular/surgical nature
  • Elektrofysiological nature (implantation ICD, CRT,…)
up to month 6
All heart failure hospitalizations
Time Frame: up to month 6
  • Treatment with (whether or not intravenous) diuretic therapy
  • Treatment with hemodynamic guided therapy (vasodilators)
  • Treatment with intravenous inotropics
up to month 6
Number of medical practitioner-patient contacts
Time Frame: up to month 6
  • In hospital (medical record)
  • General practitioner
  • At patient home (Remedus)
up to month 6
Number of (telephone) contacts, registered by the heart failure nurse
Time Frame: up to month 6
Number of (telephone) contacts, registered by the heart failure nurse
up to month 6
Number of (telephone) contacts for the encouragement of medication compliance and parameter (Remedus)
Time Frame: up to month 6
Number of (telephone) contacts for the encouragement of medication compliance (Remedus)
up to month 6
Evolution of heart failure and comorbidities
Time Frame: up to month 6
  • Blood collection with: kidney function determinations, electrolytes
  • Echo parameters (cardiac output, LVEF, diameters end systolic and diastolic)
  • Weight, length, blood pressure, ECG
up to month 6
Quality of life according to the HeartQoL questionnaire
Time Frame: day 1, month 6
Quality of life according to the HeartQoL questionnaire
day 1, month 6
Satisfaction survey
Time Frame: month 6
Satisfaction survey about the received care (anonymous) for the cardiocoach group.
month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hasselt University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Jessa Hospital
Ziekenhuis Oost-Limburg

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Vandervoort Pieter, MD, PhD, Ziekenhuis Oost-Limburg
  • Study Director: Paul Dendale, MD, PhD, Jessa Ziekenhuis, Hasselt, Belgium
  • Study Director: Jo Ravelingen, Remedus, Aartselaar, Belgium
  • Study Director: Peter Van Vooren, Fifthplay, Antwerpen, Belgium
  • Study Director: Valerie Storms, PhD, Mobile Health Unit, Hasselt University, Hasselt, Belgium
  • Principal Investigator: Lars Grieten, PhD, Mobile Health Unit, Hasselt University, Hasselt, Belgium
  • Study Chair: Christophe Smeets, PhD student, Mobile Health Unit, Hasselt University, Hasselt, Belgium

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 4, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Cardiocoach

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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