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

Primary Purpose

Heart Failure

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Telemonitoring

About this trial

This is an interventional supportive care trial for Heart Failure

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Ziekenhuis Oost-Limburg
Jessa Ziekenhuis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Telemonitoring group

Control group

Arm Description

Recieve a smartphone with an application to coach them, a blood pressure monitor and scale.

Control group (usual care, without telemonitoring)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

All-cause mortality

All cardio related hospitalizations (number and time)

Arrythmogenic nature Ischemic nature Heart failure nature Valvular/surgical nature Elektrofysiological nature (implantation ICD, CRT,…)

All heart failure hospitalizations

Treatment with (whether or not intravenous) diuretic therapy Treatment with hemodynamic guided therapy (vasodilators) Treatment with intravenous inotropics

Number of medical practitioner-patient contacts

In hospital (medical record) General practitioner At patient home (Remedus)

Number of (telephone) contacts, registered by the heart failure nurse

Number of (telephone) contacts for the encouragement of medication compliance and parameter (Remedus)

Number of (telephone) contacts for the encouragement of medication compliance (Remedus)

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

Quality of life according to the HeartQoL questionnaire

Satisfaction survey

Satisfaction survey about the received care (anonymous) for the cardiocoach group.

Full Information

NCT ID

NCT03294811

First Posted

May 20, 2014

Last Updated

May 10, 2019

Sponsor

Hasselt University

Collaborators

Ziekenhuis Oost-Limburg, Jessa Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03294811

Brief Title

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

Acronym

CardioCoach

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

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

May 1, 2014 (Actual)

Primary Completion Date

December 15, 2016 (Actual)

Study Completion Date

April 4, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hasselt University

Collaborators

Ziekenhuis Oost-Limburg, Jessa Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Telemonitoring group

Arm Type

Experimental

Arm Description

Recieve a smartphone with an application to coach them, a blood pressure monitor and scale.

Arm Title

Control group

Arm Type

No Intervention

Arm Description

Control group (usual care, without telemonitoring)

Intervention Type

Device

Intervention Name(s)

Telemonitoring

Other Intervention Name(s)

Telemedicine, remote monitoring, remote follow-up

Intervention Description

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.

Primary Outcome Measure Information:

Title

Mean medication doses

Description

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Medication titration

Description

Time Frame

after month 6

Title

All-cause mortality

Description

All-cause mortality

Time Frame

up to month 6

Title

All cardio related hospitalizations (number and time)

Description

Arrythmogenic nature Ischemic nature Heart failure nature Valvular/surgical nature Elektrofysiological nature (implantation ICD, CRT,…)

Time Frame

up to month 6

Title

All heart failure hospitalizations

Description

Treatment with (whether or not intravenous) diuretic therapy Treatment with hemodynamic guided therapy (vasodilators) Treatment with intravenous inotropics

Time Frame

up to month 6

Title

Number of medical practitioner-patient contacts

Description

In hospital (medical record) General practitioner At patient home (Remedus)

Time Frame

up to month 6

Title

Number of (telephone) contacts, registered by the heart failure nurse

Description

Number of (telephone) contacts, registered by the heart failure nurse

Time Frame

up to month 6

Title

Number of (telephone) contacts for the encouragement of medication compliance and parameter (Remedus)

Description

Number of (telephone) contacts for the encouragement of medication compliance (Remedus)

Time Frame

up to month 6

Title

Evolution of heart failure and comorbidities

Description

Blood collection with: kidney function determinations, electrolytes Echo parameters (cardiac output, LVEF, diameters end systolic and diastolic) Weight, length, blood pressure, ECG

Time Frame

up to month 6

Title

Quality of life according to the HeartQoL questionnaire

Description

Quality of life according to the HeartQoL questionnaire

Time Frame

day 1, month 6

Title

Satisfaction survey

Description

Satisfaction survey about the received care (anonymous) for the cardiocoach group.

Time Frame

month 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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)

Overall Study Officials: