Improving Adherence to Statin Therapy Through a Medication Management Application

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-17

Study Completion Date

2027-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Medication management app

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

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

Standard of care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No