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

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: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: Telemonitoring

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	after month 6
All-cause mortality	All-cause mortality	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,…)	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	up to month 6
Number of medical practitioner-patient contacts	In hospital (medical record); General practitioner; At patient home (Remedus)	up to month 6
Number of (telephone) contacts, registered by the heart failure nurse	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)	Number of (telephone) contacts for the encouragement of medication compliance (Remedus)	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	up to month 6
Quality of life according to the HeartQoL questionnaire	Quality of life according to the HeartQoL questionnaire	day 1, month 6
Satisfaction survey	Satisfaction survey about the received care (anonymous) for the cardiocoach group.	month 6

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: Jessa Hospital; Ziekenhuis Oost-Limburg
• Investigators: 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

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): December 15, 2016
• Study Completion (Actual): April 4, 2018

Study Registration Dates

• First Submitted: May 20, 2014
• First Submitted That Met QC Criteria: September 26, 2017
• First Posted (Actual): September 27, 2017

Study Record Updates

• Last Update Posted (Actual): May 13, 2019
• Last Update Submitted That Met QC Criteria: May 10, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: Cardiocoach

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED