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

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Device: Telemonitoring

• Registration Number: NCT03294811
• Lead Sponsor: Hasselt University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-01
• Study First Submitted: 2014-05-20
• Primary Completion: 2016-12-15
• Study First Submitted QC: 2017-09-26
• Study First Posted: 2017-09-27
• Study Completion: 2018-04-04
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-10
• Last Update Posted: 2019-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemonitoring group	Telemonitoring	Recieve a smartphone with an application to coach them, a blood pressure monitor and scale.

Primary Outcome Measures

Name	Time	Method
Mean medication doses	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.

Secondary Outcome Measures

Name	Time	Method
Number of medical practitioner-patient contacts	up to month 6	* In hospital (medical record); * General practitioner; * At patient home (Remedus)
Number of (telephone) contacts, registered by the heart failure nurse	up to month 6	Number of (telephone) contacts, registered by the heart failure nurse
Number of (telephone) contacts for the encouragement of medication compliance and parameter (Remedus)	up to month 6	Number of (telephone) contacts for the encouragement of medication compliance (Remedus)
Evolution of heart failure and comorbidities	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
Quality of life according to the HeartQoL questionnaire	day 1, month 6	Quality of life according to the HeartQoL questionnaire
Satisfaction survey	month 6	Satisfaction survey about the received care (anonymous) for the cardiocoach group.
All-cause mortality	up to month 6	All-cause mortality
Medication titration	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.
All cardio related hospitalizations (number and time)	up to month 6	* Arrythmogenic nature; * Ischemic nature; * Heart failure nature; * Valvular/surgical nature; * Elektrofysiological nature (implantation ICD, CRT,...)
All heart failure hospitalizations	up to month 6	* Treatment with (whether or not intravenous) diuretic therapy; * Treatment with hemodynamic guided therapy (vasodilators); * Treatment with intravenous inotropics

Trial Locations

Locations (2)

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Belgium

Jessa Ziekenhuis; 🇧🇪 Hasselt, Belgium