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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-01

Study Completion Date

2018-04-04

Brief Summary

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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.

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Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Telemonitoring group

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

Group Type EXPERIMENTAL

Telemonitoring

Intervention Type DEVICE

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.

Control group

Control group (usual care, without telemonitoring)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Telemedicine remote monitoring remote follow-up

Eligibility Criteria

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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)

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No