Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05777655
Status:
RECRUITING
Last Update Posted:
2023-03-21
First Post:
2023-02-22
Brief Title:
Improving Adherence to Statin Therapy Through a Medication Management Application
Sponsor:
University Hospital Essen
Organization:
University Hospital Essen
Study Overview
Official Title:
Improving Adherence to Statin Therapy Through a Medication Management Application STAPP
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAPP
Brief Summary:
Interventional study to compare standard of care vs standard of care plus the use of a medication therapy management smartphone app mediteo m Mediteo GmbH Heidelberg in patients with atherosclerotic cardiovascular disease and indication to start high intensity statin therapy
Detailed Description:
Patients with atherosclerotic cardiovascular disease and indication to start high intensity statin therapy will be recruited during hospital-stay or in the neurovascular outpatient clinic of the Neurology Department as well as in the Department of Cardiology and Vascular Medicine at the University Hospital Essen Participants will be randomly allocated 11 to the intervention or control arm and all will receive a Low density Lipoprotein-Cholesterin LDL-C target and a statin-prescription as standard of care All patients will be asked to take the prescribed statin in the evening and to provide LDL-C values measured by the family physician after 6 and 18 months Additional blood will be collected after 6 and 18 months to control for cardiovascular risk-factors in the study center LDL-C amongst others In addition the intervention group will receive free access to a study version of the medication management app mediteo m Mediteo GmbH Heidelberg Installation of the app will be performed on the day of enrolment After entering the medication the app will remind the patient to take his or her statin therapy according to the therapy plan Each intake has to be confirmed by the patient either directly via the reminder notification or in the app In addition the app can be used to set reminders to go the family physician to take LDL-C values and to document the personal LDL-C values The endpoint assessment will be performed in blinded manner
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None