Clinical trial NCT03294811: A Two-way Communication System to Coach Elderly Patients With Heart Failure
Official title: CARDIOCOACH: Development of an Intelligent Two-way Communication System to Coach Elderly Patients With Heart Failure in Their Home Situation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Ziekenhuis Oost-Limburg
name: Jessa Hospital
First posted: 2017-09-27
Enrollment: 25
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Mean medication doses
timeFrame: 3 months
Secondary outcomes:
measure: Medication titration
timeFrame: after month 6
measure: All-cause mortality
timeFrame: up to month 6
measure: All cardio related hospitalizations (number and time)
timeFrame: up to month 6
measure: All heart failure hospitalizations
timeFrame: up to month 6
measure: Number of medical practitioner-patient contacts
timeFrame: up to month 6
measure: Number of (telephone) contacts, registered by the heart failure nurse
timeFrame: up to month 6
measure: Number of (telephone) contacts for the encouragement of medication compliance and parameter (Remedus)
timeFrame: up to month 6
measure: Evolution of heart failure and comorbidities
timeFrame: up to month 6
measure: Quality of life according to the HeartQoL questionnaire
timeFrame: day 1, month 6
measure: Satisfaction survey
timeFrame: month 6
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
Study officials:
affiliation: Ziekenhuis Oost-Limburg
name: Vandervoort Pieter, MD, PhD
role: STUDY_DIRECTOR
affiliation: Jessa Ziekenhuis, Hasselt, Belgium
name: Paul Dendale, MD, PhD
role: STUDY_DIRECTOR
affiliation: Remedus, Aartselaar, Belgium
name: Jo Ravelingen
role: STUDY_DIRECTOR
affiliation: Fifthplay, Antwerpen, Belgium
name: Peter Van Vooren
role: STUDY_DIRECTOR
affiliation: Mobile Health Unit, Hasselt University, Hasselt, Belgium
name: Valerie Storms, PhD
role: STUDY_DIRECTOR
affiliation: Mobile Health Unit, Hasselt University, Hasselt, Belgium
name: Lars Grieten, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mobile Health Unit, Hasselt University, Hasselt, Belgium
name: Christophe Smeets, PhD student
role: STUDY_CHAIR
References:
citation: 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.