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

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.

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 1:1 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.

Standard of care (statin prescription, targeted monitoring of individual LDL-C values by primary care physician) + medication management app and follow-up visits at our institution at 6 and 18 months

Statin prescription, targeted monitoring of individual LDL-C values by primary care physician and follow-up visits at our institution at 6 and 18 months

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

Relative change in LDL-C (mg/dl) after 6 months measured by study site (or according to the value measured by the family physician, if the value measured by the study site is not available after 6 months) as compared to baseline-value

Adherence to statin therapy as measured by the German version of the Medication Adherence Report Scale (MARS-D) after 6 months

Adherence to statin therapy after 6 months as measured by the German version of the Medication Adherence Report Scale as measured by MARS-D, range 5-25, higher scores indicating better adherence

Measured by the German version of the A14 scale, range 0 - 56, lower scores indicating better adherence

Change in Quality of life score EQ-5D-5L is a standardised measure of health status developed by the EuroQol Group including 5 dimensions, 5 levels and the EQ visual analogue scale [VAS] from 0 to 100 with higher values indicating higher quality of life

The BMQ consists of two sections assessing personal beliefs about the necessity of prescribed medication (5 items) and concerns (5 items). Scores range from 5 to 25 with higher scores indicating a higher degree of necessity/concern.

Incidence of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina or urgent coronary revascularization therapy after 6 months

Change in highest degree of extracranial stenosis (%) as determined by carotid ultrasound using North American Carotid Endarterectomy Trial (NASCET) criteria after 6 months

Relative change in LDL-C (mg/dl) after 18 months measured by study site (or according to the value measured by the family physician, if the value measured by the study site is not available) as compared to baseline-value

Adherence to statin therapy as measured by the German version of the Medication Adherence Report Scale (MARS-D) after 18 months

Adherence to statin therapy after 18 months as measured by the German version of the Medication Adherence Report Scale as measured by MARS-D, range 5-25, higher scores indicating better adherence

Measured by the German version of the A14 scale, range 0 - 56, lower scores indicating better adherence

Change in Quality of life score EQ-5D-5L is a standardised measure of health status developed by the EuroQol Group including 5 dimensions, 5 levels and the EQ visual analogue scale [VAS] from 0 to 100 with higher values indicating higher quality of life

The BMQ consists of two sections assessing personal beliefs about the necessity of prescribed medication (5 items) and concerns (5 items). Scores range from 5 to 25 with higher scores indicating a higher degree of necessity/concern.

Incidence of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina or urgent coronary revascularization therapy after 18 months

Change in highest degree of extracranial stenosis (%) as determined by carotid ultrasound using North American Carotid Endarterectomy Trial (NASCET) criteria after 18 months

Inclusion Criteria: 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 Criteria: 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