The Effects of a CONCOR Smartphone Application

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Congenital Heart Disease, Smartphone Application, Arrhythmia, Heart Failure, mHealth, Mobile Health

Intervention / Treatment
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* Device: CONCOR smartphone application


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CONCOR smartphone application<br>Use of CONCOR smartphone application | Device: CONCOR smartphone application<br> <br> |
| No Intervention: Standard care (no CONCOR smartphone application)<br>No CONCOR smartphone application | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of arrhythmia and heart failure events |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life questionnaire |  | 1 year | 
| Mortality |  | 1 year | 
| Medication adherence questionnaire |  | 1 year | 
| Usability and learnability questionnaire |  | 1 year |