Improving Adherence to Statin Therapy Through a Medication Management Application
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Medication management app (mediteo m+, Mediteo GmbH, Heidelberg).
- Who it may be relevant to
- Registry conditions: Atherosclerosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Improving Adherence to Statin Therapy Through a Medication Management Application (STAPP)
Overview
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.
Interventions
- Other Medication 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
Primary outcome measures
- Relative change in LDL-C [Time frame: 6 months]
Secondary outcome measures (12)
- Modified Rankin Scale (mRS)-Score after 6 months [Time frame: 6 months]
- Proportion of available LDL-C values measured by the family physician after 6 months [Time frame: 6 months]
- Relative change in high density lipoprotein-cholesterol (HDL-C) after 6 months [Time frame: 6 months]
- Relative change in total cholesterol after 6 months [Time frame: 6 months]
- Relative change in hemoglobin A1C (HbA1c) after 6 months [Time frame: 6 months]
- Relative change in high-sensitivity C-reactive protein (hsCRP) after 6 months [Time frame: 6 months]
- Relative change in Lipoprotein (a) after 6 months [Time frame: 6 months]
- Relative change in glutamic oxaloacetic transaminase (GOT) after 6 months [Time frame: 6 months]
- Relative change in glutamate-pyruvate transaminase (GPT) [Time frame: 6 months]
- Relative change in creatine kinase (CK) after 6 months [Time frame: 6 months]
- Adherence to statin therapy as measured by the German version of the Medication Adherence Report Scale (MARS-D) after 6 months [Time frame: 6 months]
- Adherence to statin therapy as measured by the German version of the A14 scale after 6 months [Time frame: 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Germany · 1 center
- University Hospital, Essen — Essen
Identifiers
NCT: NCT05777655 · 21-10444