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The Effects of a CONCOR Smartphone Application

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02599857
Recruitment Status : Withdrawn (never started)
First Posted : November 9, 2015
Last Update Posted : May 24, 2017
Information provided by (Responsible Party):
Mark Schuuring, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary:
Life expectancy of children with congenital heart disease (CHD) has increased dramatically during the past years, due to the successes of cardiac surgery. Nearly all of these children with CHD can be operated at young age and more than 90% reach adulthood. However, many adults with CHD are life-long affected by cardiac events, particularly arrhythmias and heart failure, putting them at risk of premature death. These events have a large impact on quality of life of patients and their families and merit life-long hospital visits in a medical center specialized in adult CHD. Especially for adults with CHD patient care with a smartphone is suited because of their young age and chronic condition. So far, data are lacking on smartphone interventions in patients with CHD.

Condition or disease Intervention/treatment Phase
Congenital Heart Disease Smartphone Application Arrhythmia Heart Failure mHealth Mobile Health Device: CONCOR smartphone application Not Applicable

Detailed Description:
The investigators aim to determine feasibility of CONCOR smartphone application management in adults with CHD. Moreover, during a twelve months follow up period the investigators aim to evaluate whether management with a CONCOR smartphone application results in a lower rate of heart failure events and arrhythmia as well as a better quality of life than usual care, because of increased patient awareness, behavioral stimuli, healthy life style reminders and more precise medical treatment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of a CONCOR Smartphone Application on Arrhythmia, Heart Failure Events and Quality of Life in Patients With Congenital Heart Disease: a Randomized Controlled Trial
Estimated Study Start Date : January 1, 2017
Estimated Primary Completion Date : May 1, 2017
Estimated Study Completion Date : May 1, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: CONCOR smartphone application
Use of CONCOR smartphone application
Device: CONCOR smartphone application
No Intervention: Standard care (no CONCOR smartphone application)
No CONCOR smartphone application

Primary Outcome Measures :
  1. Composite of arrhythmia and heart failure events [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Quality of life questionnaire [ Time Frame: 1 year ]
  2. Mortality [ Time Frame: 1 year ]
  3. Medication adherence questionnaire [ Time Frame: 1 year ]
  4. Usability and learnability questionnaire [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adults with CHD being an Academic Medical Center (AMC) patient and/ or patients registered in the Dutch CONCOR registry
  • Owning a smartphone

Exclusion Criteria:

  • Mental retardation and/ or Down syndrome

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02599857

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Academic Medical Center
Amsterdam, Netherlands
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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Responsible Party: Mark Schuuring, MD PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Identifier: NCT02599857     History of Changes
Other Study ID Numbers: 2015-126481
First Posted: November 9, 2015    Key Record Dates
Last Update Posted: May 24, 2017
Last Verified: November 2015

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
Antihypertensive Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action