The Effects of a CONCOR Smartphone Application

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02599857
• Other study ID #: 2015-126481
• Status: Withdrawn
• Phase: N/A
• First received: November 5, 2015
• Last updated: May 23, 2017
• Start date: January 1, 2017
• Est. completion date: May 1, 2017

Study information

• Verified date: November 2015
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 1, 2017
• Est. primary completion date: May 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmia
• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Heart Failure
• mHealth
• Mobile Health
• Smartphone Application

Intervention

Device:
• CONCOR smartphone application

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of arrhythmia and heart failure events		1 year
Secondary	Quality of life questionnaire		1 year
Secondary	Mortality		1 year
Secondary	Medication adherence questionnaire		1 year
Secondary	Usability and learnability questionnaire		1 year