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

NCT03294811 | Completed

• 1 other identifier: Cardiocoach
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (10)

• 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

Study Arms (2)

Telemonitoring group

EXPERIMENTAL

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

Device: Telemonitoring

Control group

NO INTERVENTION

Control group (usual care, without telemonitoring)

Interventions

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.

Also known as: Telemedicine, remote monitoring, remote follow-up

Telemonitoring group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Reversible form of heart failure
• Heart failure due to severe aortic stenosis
• 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)

Sponsors & Collaborators

• Hasselt University: lead
• Ziekenhuis Oost-Limburg: collaborator
• Jessa Hospital: collaborator

Study Sites (2)

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Location

Jessa Ziekenhuis

Hasselt, 3500, Belgium

Location

Related Publications (1)

• Smeets CJ, Storms V, Vandervoort PM, Dreesen P, Vranken J, Houbrechts M, Goris H, Grieten L, Dendale P. A Novel Intelligent Two-Way Communication System for Remote Heart Failure Medication Uptitration (the CardioCoach Study): Randomized Controlled Feasibility Trial. JMIR Cardio. 2018 Apr 4;2(1):e8. doi: 10.2196/cardio.9153.

  PMID: 31758773 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Vandervoort Pieter, MD, PhD

  Ziekenhuis Oost-Limburg

  STUDY DIRECTOR

• Paul Dendale, MD, PhD

  Jessa Ziekenhuis, Hasselt, Belgium

  STUDY DIRECTOR

• Jo Ravelingen

  Remedus, Aartselaar, Belgium

  STUDY DIRECTOR

• Peter Van Vooren

  Fifthplay, Antwerpen, Belgium

  STUDY DIRECTOR

• Valerie Storms, PhD

  Mobile Health Unit, Hasselt University, Hasselt, Belgium

  STUDY DIRECTOR

• Lars Grieten, PhD

  Mobile Health Unit, Hasselt University, Hasselt, Belgium

  PRINCIPAL INVESTIGATOR

• Christophe Smeets, PhD student

  Mobile Health Unit, Hasselt University, Hasselt, Belgium

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr.

Study Record Dates

• First Submitted: May 20, 2014
• First Posted: September 27, 2017
• Study Start: May 1, 2014
• Primary Completion: December 15, 2016
• Study Completion: April 4, 2018
• Last Updated: May 13, 2019

Record last verified: 2019-05

Locations

BE (2)