mHealth in Grown-up Congenital Heart Disease
Completed
- Conditions
- Congenital heart diseasesymptomatic1001039410007510
- Registration Number
- NL-OMON49010
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 196
Inclusion Criteria
> 18 years
Congenital heart disease patient
Symptomatic in the last 1 year: Heart failure NYHA class * II, palpitations or
arrhythmias, hypertension.
Patients with a genetic abnormality resulting in an altered cardiac anatomy or
function.
Exclusion Criteria
Unable to give informed consent
Tremor
Not in possession of smart phone or personal computer
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p> The primary research question is to assess the effect of mHealth-based<br /><br>monitoring on the number of contact moments with the hospital (i.e. contact<br /><br>with the outpatient clinic (visits and telephone consults), visits to the<br /><br>emergency department, and hospitalizations), in comparison with the control<br /><br>group. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary research questions are superiority of health-related quality of life,<br /><br>as measured with the EuroQol-5D-5L, SF-36 and PAM-13 using the mHealth<br /><br>intervention in comparison with the control group and the number of contact<br /><br>moments, outpatient clinic visits, ER visits and emergency admissions. Research<br /><br>questions on cost effectiveness are whether a mHealth-based monitoring pathway<br /><br>leads to cost reduction through change in the number of contact moments with<br /><br>the hospital (i.e. contact with the outpatient clinic (visits and telephone<br /><br>consults), visits to the emergency department, and hospitalizations), in<br /><br>comparison with the control group.</p><br>