NCT02599857

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 9, 2015

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 24, 2017

Status Verified

November 1, 2015

Enrollment Period

4 months

First QC Date

November 5, 2015

Last Update Submit

May 23, 2017

Conditions

Congenital Heart DiseaseSmartphone ApplicationArrhythmiaHeart FailuremHealthMobile Health

Outcome Measures

Primary Outcomes (1)

  • Composite of arrhythmia and heart failure events

    1 year

Secondary Outcomes (4)

  • Quality of life questionnaire

    1 year

  • Mortality

    1 year

  • Medication adherence questionnaire

    1 year

  • Usability and learnability questionnaire

    1 year

Study Arms (2)

CONCOR smartphone application

EXPERIMENTAL

Use of CONCOR smartphone application

Device: CONCOR smartphone application

Standard care (no CONCOR smartphone application)

NO INTERVENTION

No CONCOR smartphone application

Interventions

CONCOR smartphone applicationDEVICE
CONCOR smartphone application

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults with CHD being an Academic Medical Center (AMC) patient and/ or patients registered in the Dutch CONCOR registry
  • Owning a smartphone

You may not qualify if:

  • Mental retardation and/ or Down syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Medical Center

Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Heart Defects, CongenitalArrhythmias, CardiacHeart Failure

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

November 5, 2015

First Posted

November 9, 2015

Study Start

January 1, 2017

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

May 24, 2017

Record last verified: 2015-11

Locations

NL(1)