The Effects of a CONCOR Smartphone Application

NCT ID: NCT02599857

Last Updated: 2017-05-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2017-05-01

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.

Conditions

Congenital Heart Disease; Smartphone Application; Arrhythmia; Heart Failure; mHealth; Mobile Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CONCOR smartphone application

Use of CONCOR smartphone application

Group Type: EXPERIMENTAL

CONCOR smartphone application

Intervention Type: DEVICE

Standard care (no CONCOR smartphone application)

No CONCOR smartphone application

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CONCOR smartphone application

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: lead

Responsible Party

Mark Schuuring

MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Academic Medical Center

Amsterdam, , Netherlands

Countries

Netherlands

Other Identifiers

2015-126481

Identifier Type: -

Identifier Source: org_study_id