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

Heart Failure Clinical Trial

— CardioCoach  

Official title:

CARDIOCOACH: Development of an Intelligent Two-way Communication System to Coach Elderly Patients With Heart Failure in Their Home Situation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03294811
• Other study ID #: Cardiocoach
• Status: Completed
• Phase: N/A
• Start date: May 1, 2014
• Est. completion date: April 4, 2018

Study information

• Verified date: May 2019
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 4, 2018
• Est. primary completion date: December 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk
Belgium	Jessa Ziekenhuis	Hasselt

Sponsors (3)

Lead Sponsor	Collaborator
Hasselt University	Jessa Hospital, Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean medication doses	Mean daily doses of ACE-inhibitors/ARB's, ß 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	Medication titration	Mean daily doses of ACE-inhibitors/ARB's, ß 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
Secondary	All-cause mortality	All-cause mortality	up to month 6
Secondary	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
Secondary	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
Secondary	Number of medical practitioner-patient contacts	In hospital (medical record); General practitioner; At patient home (Remedus)	up to month 6
Secondary	Number of (telephone) contacts, registered by the heart failure nurse	Number of (telephone) contacts, registered by the heart failure nurse	up to month 6
Secondary	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
Secondary	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
Secondary	Quality of life according to the HeartQoL questionnaire	Quality of life according to the HeartQoL questionnaire	day 1, month 6
Secondary	Satisfaction survey	Satisfaction survey about the received care (anonymous) for the cardiocoach group.	month 6