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mHealth in Grown-up Congenital Heart Disease

mHealth in Grown-up Congenital Heart Disease - eGUCH

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON49010
Enrollment
196
Registered
2019-01-23
Start date
2019-05-06
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital heart disease symptomatic

Interventions

Patients in the intervention group will be monitored for 24 months. The mHealth telemonitoring program will be used in addition to usual care. The mHealth telemonitoring program will monitor body we

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Unable to give informed consent Tremor Not in possession of smart phone or personal computer

Design outcomes

Primary

MeasureTime frame
The primary research question is to assess the effect of mHealth-based monitoring on the number of contact moments with the hospital (i.e. contact with the outpatient clinic (visits and telephone consults), visits to the emergency department, and hospitalizations), in comparison with the control group.

Secondary

MeasureTime frame
Secondary research questions are superiority of health-related quality of life, as measured with the EuroQol-5D-5L, SF-36 and PAM-13 using the mHealth intervention in comparison with the control group and the number of contact moments, outpatient clinic visits, ER visits and emergency admissions. Research questions on cost effectiveness are whether a mHealth-based monitoring pathway leads to cost reduction through change in the number of contact moments with the hospital (i.e. contact with the outpatient clinic (visits and telephone consults), visits to the emergency department, and hospitalizations), in comparison with the control group.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)