Clinical trial NCT05777655: Improving Adherence to Statin Therapy Through a Medication Management Application
Official title: Improving Adherence to Statin Therapy Through a Medication Management Application (STAPP)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atherosclerosis
Keywords: Smartphone Application
Medication Therapy Management
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Relative change in LDL-C
timeFrame: 6 months
Secondary outcomes:
measure: Modified Rankin Scale (mRS)-Score after 6 months
timeFrame: 6 months
measure: Proportion of available LDL-C values measured by the family physician after 6 months
timeFrame: 6 months
measure: Relative change in high density lipoprotein-cholesterol (HDL-C) after 6 months
timeFrame: 6 months
measure: Relative change in total cholesterol after 6 months
timeFrame: 6 months
measure: Relative change in hemoglobin A1C (HbA1c) after 6 months
timeFrame: 6 months
measure: Relative change in high-sensitivity C-reactive protein (hsCRP) after 6 months
timeFrame: 6 months
measure: Relative change in Lipoprotein (a) after 6 months
timeFrame: 6 months
measure: Relative change in glutamic oxaloacetic transaminase (GOT) after 6 months
timeFrame: 6 months
measure: Relative change in glutamate-pyruvate transaminase (GPT)
timeFrame: 6 months
measure: Relative change in creatine kinase (CK) after 6 months
timeFrame: 6 months
measure: Adherence to statin therapy as measured by the German version of the Medication Adherence Report Scale (MARS-D) after 6 months
timeFrame: 6 months
measure: Adherence to statin therapy as measured by the German version of the A14 scale after 6 months
timeFrame: 6 months
measure: Change in Quality of life score EQ-5D-5L after 6 months
timeFrame: 6 months
measure: Change in Beliefs about Medicines Questionnaire (BMQ) after 6 months
timeFrame: 6 months
measure: Incidence of major vascular events after 6 months
timeFrame: 6 months
measure: Change in highest degree of extracranial stenosis after 6 months
timeFrame: 6 months
measure: Change in maximum height of largest carotid plaque after 6 months
timeFrame: 6 months
measure: Change in longitudinal area of largest carotid plaque after 6 months
timeFrame: 6 months
measure: Change in cross-sectional area of largest carotid plaque after 6 months
timeFrame: 6 months
measure: Relative change in LDL-C after 18 months
timeFrame: 18 months
measure: Modified Rankin Scale (mRS)-Score after 18 months
timeFrame: 18 months
measure: Proportion of available LDL-C values measured by the family physician after 18 months
timeFrame: 18 months
measure: Relative change in high density lipoprotein-cholesterol (HDL-C) after 18 months
timeFrame: 18 months
measure: Relative change in total cholesterol after 18 months
timeFrame: 18 months
measure: Relative change in hemoglobin A1C (HbA1c) after 18 months
timeFrame: 18 months
measure: Relative change in high-sensitivity C-reactive protein (hsCRP) after 18 months
timeFrame: 18 months
measure: Relative change in Lipoprotein (a) after 18 months
timeFrame: 18 months
measure: Relative change in glutamic oxaloacetic transaminase (GOT) after 18 months
timeFrame: 18 months
measure: Relative change in glutamate-pyruvate transaminase (GPT) after 18 months
timeFrame: 18 months
measure: Relative change in creatine kinase (CK) after 18 months
timeFrame: 18 months
measure: Adherence to statin therapy as measured by the German version of the Medication Adherence Report Scale (MARS-D) after 18 months
timeFrame: 18 months
measure: Adherence to statin therapy as measured by the German version of the A14 scale after 18 months
timeFrame: 18 months
measure: Change in Quality of life score EQ-5D-5L after 18 months
timeFrame: 18 months
measure: Change in Beliefs about Medicines Questionnaire (BMQ) after 18 months
timeFrame: 18 months
measure: Incidence of major vascular events after 18 months
timeFrame: 18 months
measure: Change in highest degree of extracranial stenosis after 18 months
timeFrame: 18 months
measure: Change in maximum height of largest carotid plaque after 18 months
timeFrame: 18 months
measure: Change in longitudinal area of largest carotid plaque after 18 months
timeFrame: 18 months
measure: Change in cross-sectional area of largest carotid plaque after 18 months
timeFrame: 18 months
Other outcomes:
Locations:
city: Essen
country: Germany
facility: University Hospital, Essen
state: Nordrhein-Westfalen
Study officials:
References: