The Effects of a CONCOR Smartphone Application

Not Applicable

Withdrawn

• Conditions: Mobile Health; Smartphone Application; Congenital Heart Disease; Arrhythmia; Heart Failure; mHealth
• Interventions: Device: CONCOR smartphone application

• Registration Number: NCT02599857
• Lead Sponsor: 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.

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.

Study Timeline

• Status Verified: 2015-11
• Study First Submitted: 2015-11-05
• Study First Submitted QC: 2015-11-06
• Study First Posted: 2015-11-09
• Study Start: 2017-01-01
• Primary Completion: 2017-05-01
• Study Completion: 2017-05-01
• Last Update Submitted: 2017-05-23
• Last Update Posted: 2017-05-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CONCOR smartphone application	CONCOR smartphone application	Use of CONCOR smartphone application

Primary Outcome Measures

Name	Time	Method
Composite of arrhythmia and heart failure events	1 year

Secondary Outcome Measures

Name	Time	Method
Mortality	1 year
Medication adherence questionnaire	1 year
Quality of life questionnaire	1 year
Usability and learnability questionnaire	1 year

Trial Locations

Locations (1)

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands