The Effects of a CONCOR Smartphone Application

May 23, 2017 updated by: Mark Schuuring, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
        • Academic Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite of arrhythmia and heart failure events
Time Frame: 1 year
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2017

Primary Completion (ANTICIPATED)

May 1, 2017

Study Completion (ANTICIPATED)

May 1, 2017

Study Registration Dates

First Submitted

November 5, 2015

First Submitted That Met QC Criteria

November 6, 2015

First Posted (ESTIMATE)

November 9, 2015

Study Record Updates

Last Update Posted (ACTUAL)

May 24, 2017

Last Update Submitted That Met QC Criteria

May 23, 2017

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-126481

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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