Criteria
Study centerInfrastructure
Experience / - Internet access that allows to access the database "ISP" in the center
- Please not that the study participants must have access to a mobile device that is compatible with CardioSecur ACTIVE. Currently these devices are certain Apple devices* however selected Android devices will be available in Q4 2015.
- Experience in conducting and publishing the results of clinical trials
- Experience in telemedicine are desired, but not required **
Study design
Study design and conduction / - GCP & Declaration of Helsinki must be considered, an ethical vote must be obtained
- First interim results should be available 12 months following the inclusion of the first patient
- Minimum. 50 patients should be included
Endpoint / - Endpoints should address the impact of CardioSecur ACTIVE on at least one of the following
- Individual burden of disease (for example quality of life or other patient reported outcomes) or
- Financial burden of disease (for example direct or indirect medical cost) or
- Process management and patient care
* CardioSecur ACTIVE is compatible with the following iOS devices: iPhone: 5 / 5S / 5C / 4 / 4S iPad: iPad Air, iPad mini, iPad 3rd / 4th generation iPod touch: 4th / 5th Generation. It will be available for selected Android devices by the end of 2015.
** PhD students are explicitly encouraged to participate in this call also referring to the expertise of their supervisor.
Application Form
Study CentreStudy Center
Study Responsible
Relevant clinical and scientific experience / - Please provide at least 5 relevant publications. -
Study Design
Background
Issue
Primary endpoints
Secondary endpoints
If applicable exploratory endpoints
Expected results regarding the endpoints
for individual / financial burden of disease and / or process management and patient care
Desired amount of devices (max. 10)
Number of patients
Appreciated start of the study (month / year)
Appreciated recruitment period
Observation period
Estimated study time
! Max. four pages!
CardioSecur trials