Using a smartphone app to improve statin therapy adherence in patients with atherosclerosis
Improving Adherence to Statin Therapy Through a Medication Management Application (STAPP)
This study is testing if using a smartphone app to remind people with atherosclerosis to take their statin medication can help them stick to their treatment better than just regular care alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Essen Academic / other |
| Locations | 1 site (Essen, North Rhine-Westphalia) |
| Trial ID | NCT05777655 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with atherosclerosis who are statin-naive and have an LDL-C level greater than 100 mg/dl.
Not a fit: Patients who cannot independently use a smartphone app or take medication, such as those with dementia or severe disabilities, will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve adherence to statin therapy, leading to better management of atherosclerosis and reduced cardiovascular events.
How similar studies have performed: Other studies have shown promising results using digital health interventions to improve medication adherence, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Essen, North Rhine-Westphalia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.