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Completed

NCT Number: NCT03294811

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

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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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ziekenhuis Oost-Limburg, Genk, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Telemonitoring

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.

Other names: Telemedicine, remote monitoring, remote follow-up

Primary outcomes

  1. 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

  1. Medication titration

    Time frame: 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.

  2. All-cause mortality

    Time frame: up to month 6

    All-cause mortality

  3. All cardio related hospitalizations (number and time)

    Time frame: up to month 6

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

  4. All heart failure hospitalizations

    Time frame: up to month 6

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

  5. Number of medical practitioner-patient contacts

    Time frame: up to month 6

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

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

    Time frame: up to month 6

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

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

    Time frame: up to month 6

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

  8. Evolution of heart failure and comorbidities

    Time frame: 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

  9. Quality of life according to the HeartQoL questionnaire

    Time frame: day 1, month 6

    Quality of life according to the HeartQoL questionnaire

  10. Satisfaction survey

    Time frame: month 6

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

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

  • Jessa Hospital
  • Ziekenhuis Oost-Limburg

Registry information

Official study title

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

Acronym: CardioCoach

Important dates

Study start
2014
Primary completion
2016
Study completion
2018
First posted
Sep 27, 2017
Registry last updated
May 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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