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Clinical Trials/NCT03294811
NCT03294811
Completed
Not Applicable

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

Hasselt University2 sites in 1 country25 target enrollmentMay 1, 2014
ConditionsHeart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Hasselt University
Enrollment
25
Locations
2
Primary Endpoint
Mean medication doses
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2014
End Date
April 4, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hasselt University
Responsible Party
Principal Investigator
Principal Investigator

Pieter Vandervoort

prof. dr.

Hasselt University

Eligibility Criteria

Inclusion Criteria

  • 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)

Outcomes

Primary Outcomes

Mean medication doses

Time Frame: 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 Outcomes

  • Medication titration(after month 6)
  • All-cause mortality(up to month 6)
  • All cardio related hospitalizations (number and time)(up to month 6)
  • All heart failure hospitalizations(up to month 6)
  • Number of medical practitioner-patient contacts(up to month 6)
  • Number of (telephone) contacts, registered by the heart failure nurse(up to month 6)
  • Number of (telephone) contacts for the encouragement of medication compliance and parameter (Remedus)(up to month 6)
  • Evolution of heart failure and comorbidities(up to month 6)
  • Quality of life according to the HeartQoL questionnaire(day 1, month 6)
  • Satisfaction survey(month 6)

Study Sites (2)

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