The Effects of a CONCOR Smartphone Application
Primary Purpose
Congenital Heart Disease, Smartphone Application, Arrhythmia
Status
Withdrawn
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
CONCOR smartphone application
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Heart Disease
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
Sites / Locations
- Academic Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
CONCOR smartphone application
Standard care (no CONCOR smartphone application)
Arm Description
Use of CONCOR smartphone application
No CONCOR smartphone application
Outcomes
Primary Outcome Measures
Composite of arrhythmia and heart failure events
Secondary Outcome Measures
Quality of life questionnaire
Mortality
Medication adherence questionnaire
Usability and learnability questionnaire
Full Information
NCT ID
NCT02599857
First Posted
November 5, 2015
Last Updated
May 23, 2017
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1. Study Identification
Unique Protocol Identification Number
NCT02599857
Brief Title
The Effects of a CONCOR Smartphone Application
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Withdrawn
Why Stopped
never started
Study Start Date
January 1, 2017 (Anticipated)
Primary Completion Date
May 1, 2017 (Anticipated)
Study Completion Date
May 1, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease, Smartphone Application, Arrhythmia, Heart Failure, mHealth, Mobile Health
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CONCOR smartphone application
Arm Type
Experimental
Arm Description
Use of CONCOR smartphone application
Arm Title
Standard care (no CONCOR smartphone application)
Arm Type
No Intervention
Arm Description
No CONCOR smartphone application
Intervention Type
Device
Intervention Name(s)
CONCOR smartphone application
Primary Outcome Measure Information:
Title
Composite of arrhythmia and heart failure events
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Quality of life questionnaire
Time Frame
1 year
Title
Mortality
Time Frame
1 year
Title
Medication adherence questionnaire
Time Frame
1 year
Title
Usability and learnability questionnaire
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Academic Medical Center
City
Amsterdam
Country
Netherlands
12. IPD Sharing Statement
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The Effects of a CONCOR Smartphone Application
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