RecruitingNot ApplicableNCT05777655

Improving Adherence to Statin Therapy Through a Medication Management Application

Improving Adherence to Statin Therapy Through a Medication Management Application (STAPP)


Sponsor

University Hospital, Essen

Enrollment

250 participants

Start Date

Feb 17, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Age >18 years
  • Atherosclerosis (neurovascular, cardiac or peripheral) with an indication to start a high intensity statin-therapy (equivalent to 40mg of atorvastatin or 20mg of rosuvastatin; start of statin therapy +/- 10 days of enrolment)
  • Statin naivety
  • LDL-C >100 mg/dl. No older than 21 days

Exclusion Criteria8

  • Inability to take medication independently or to use the mediteo m+ app independently (e.g. people in need of care, people with dementia)
  • Patient has no own smartphone (no device provided for this study)
  • Prior drug therapy to lower LDL-C within the last 30 days
  • Active cancer (defined as a diagnosis of cancer within 6 months before enrolment, any treatment for cancer within the previous 6 months, or recurrent or metastatic cancer) or other severe concomitant disease with a life expectancy of <6 months
  • Use of a digital therapy management application (including mediteo or mediteo m+) within the last month
  • Participation in another interventional trial
  • Pregnancy
  • Inability or unwillingness to provide informed consent

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Interventions

OTHERMedication management app (mediteo m+, Mediteo GmbH, Heidelberg)

Free access to a study version of the medication management app mediteo m+ for reminders and documentation of statin therapy in addition to usual care


Locations(1)

University Hospital, Essen

Essen, North Rhine-Westphalia, Germany

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NCT05777655


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