mHealth in Grown-up Congenital Heart Disease

Completed

• Conditions: Congenital heart disease; symptomatic; 10010394; 10007510

• Registration Number: NL-OMON49010
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

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>