Using a smartphone app to improve statin therapy adherence in patients with atherosclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study aims to compare the effectiveness of standard care versus standard care combined with a medication management smartphone application, mediteo m+, for patients with atherosclerotic cardiovascular disease who need to start high-intensity statin therapy. Participants will be randomly assigned to either the intervention group, which will use the app to receive reminders and document their medication intake, or the control group, which will receive standard care only. The study will monitor LDL-C levels and other cardiovascular risk factors over 6 and 18 months to assess the impact of the app on medication adherence and health outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• University Hospital, Essen
  Essen, North Rhine-Westphalia, Germany Recruiting

Study contacts

• Study coordinator: Benedikt Frank, PD Dr.
• Email: benedikt.frank@uk-essen.de
• Phone: +49 201

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.