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NCT Number: NCT05777655

Improving Adherence to Statin Therapy Through a Medication Management Application

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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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Relative change in LDL-C

    Time frame: 6 months

    Relative change in LDL-C (mg/dl) after 6 months measured by study site (or according to the value measured by the family physician, if the value measured by the study site is not available after 6 months) as compared to baseline-value

Secondary outcomes

  1. Modified Rankin Scale (mRS)-Score after 6 months

    Time frame: 6 months

    Change in mRS [0 to 6, higher scores indicating worse outcome] after 6 months

  2. Proportion of available LDL-C values measured by the family physician after 6 months

    Time frame: 6 months

    Proportion of available LDL-C values measured by the family physician after 6 months

  3. Relative change in high density lipoprotein-cholesterol (HDL-C) after 6 months

    Time frame: 6 months

    Relative change in HDL-C (mg/dl) after 6 months as compared to baseline-value

  4. Relative change in total cholesterol after 6 months

    Time frame: 6 months

    Relative change in total cholesterol (mg/dl) after 6 months as compared to baseline-value

  5. Relative change in hemoglobin A1C (HbA1c) after 6 months

    Time frame: 6 months

    Relative change in HbA1c (%) after 6 months as compared to baseline-value

  6. Relative change in high-sensitivity C-reactive protein (hsCRP) after 6 months

    Time frame: 6 months

    Relative change in hsCRP (mg/dl) after 6 months as compared to baseline-value

  7. Relative change in Lipoprotein (a) after 6 months

    Time frame: 6 months

    Relative change in Lipoprotein (a) (mg/dl) after 6 months as compared to baseline-value

  8. Relative change in glutamic oxaloacetic transaminase (GOT) after 6 months

    Time frame: 6 months

    Relative change in GOT (U/l) after 6 months as compared to baseline-value

  9. Relative change in glutamate-pyruvate transaminase (GPT)

    Time frame: 6 months

    Relative change in GPT (U/l) after 6 months as compared to baseline-value

  10. Relative change in creatine kinase (CK) after 6 months

    Time frame: 6 months

    Relative change in CK (U/l) after 6 months as compared to baseline-value

  11. 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 after 6 months as measured by the German version of the Medication Adherence Report Scale as measured by MARS-D, range 5-25, higher scores indicating better adherence

  12. Adherence to statin therapy as measured by the German version of the A14 scale after 6 months

    Time frame: 6 months

    Measured by the German version of the A14 scale, range 0 - 56, lower scores indicating better adherence

  13. Change in Quality of life score EQ-5D-5L after 6 months

    Time frame: 6 months

    Change in Quality of life score EQ-5D-5L is a standardised measure of health status developed by the EuroQol Group including 5 dimensions, 5 levels and the EQ visual analogue scale [VAS] from 0 to 100 with higher values indicating higher quality of life

  14. Change in Beliefs about Medicines Questionnaire (BMQ) after 6 months

    Time frame: 6 months

    The BMQ consists of two sections assessing personal beliefs about the necessity of prescribed medication (5 items) and concerns (5 items). Scores range from 5 to 25 with higher scores indicating a higher degree of necessity/concern.

  15. Incidence of major vascular events after 6 months

    Time frame: 6 months

    Incidence of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina or urgent coronary revascularization therapy after 6 months

  16. Change in highest degree of extracranial stenosis after 6 months

    Time frame: 6 months

    Change in highest degree of extracranial stenosis (%) as determined by carotid ultrasound using North American Carotid Endarterectomy Trial (NASCET) criteria after 6 months

  17. Change in maximum height of largest carotid plaque after 6 months

    Time frame: 6 months

    Change in maximum height of largest carotid plaque (mm) on carotid ultrasound after 6 months

  18. Change in longitudinal area of largest carotid plaque after 6 months

    Time frame: 6 months

    Change in longitudinal area of largest carotid plaque [mm2] on carotid ultrasound after 6 months

  19. Change in cross-sectional area of largest carotid plaque after 6 months

    Time frame: 6 months

    Change in cross-sectional area of largest carotid plaque [mm2] on carotid ultrasound after 6 months

  20. Relative change in LDL-C after 18 months

    Time frame: 18 months

    Relative change in LDL-C (mg/dl) after 18 months measured by study site (or according to the value measured by the family physician, if the value measured by the study site is not available) as compared to baseline-value

  21. Modified Rankin Scale (mRS)-Score after 18 months

    Time frame: 18 months

    Change in mRS [0 to 6, higher scores indicating worse outcome] after 18 months

  22. Proportion of available LDL-C values measured by the family physician after 18 months

    Time frame: 18 months

    Proportion of available LDL-C values measured by the family physician after 18 months

  23. Relative change in high density lipoprotein-cholesterol (HDL-C) after 18 months

    Time frame: 18 months

    Relative change in HDL-C (mg/dl) after 18 months as compared to baseline-value

  24. Relative change in total cholesterol after 18 months

    Time frame: 18 months

    Relative change in total cholesterol (mg/dl) after 18 months as compared to baseline-value

  25. Relative change in hemoglobin A1C (HbA1c) after 18 months

    Time frame: 18 months

    Relative change in HbA1c (%) after 18 months as compared to baseline-value

  26. Relative change in high-sensitivity C-reactive protein (hsCRP) after 18 months

    Time frame: 18 months

    Relative change in hsCRP (mg/dl) after 18 months as compared to baseline-value

  27. Relative change in Lipoprotein (a) after 18 months

    Time frame: 18 months

    Relative change in Lipoprotein (a) (mg/dl) after 18 months as compared to baseline-value

  28. Relative change in glutamic oxaloacetic transaminase (GOT) after 18 months

    Time frame: 18 months

    Relative change in GOT (U/l) after 18 months as compared to baseline-value

  29. Relative change in glutamate-pyruvate transaminase (GPT) after 18 months

    Time frame: 18 months

    Relative change in GPT (U/l) after18 months as compared to baseline-value

  30. Relative change in creatine kinase (CK) after 18 months

    Time frame: 18 months

    Relative change in CK (U/l) after 18 months as compared to baseline-value

  31. Adherence to statin therapy as measured by the German version of the Medication Adherence Report Scale (MARS-D) after 18 months

    Time frame: 18 months

    Adherence to statin therapy after 18 months as measured by the German version of the Medication Adherence Report Scale as measured by MARS-D, range 5-25, higher scores indicating better adherence

  32. Adherence to statin therapy as measured by the German version of the A14 scale after 18 months

    Time frame: 18 months

    Measured by the German version of the A14 scale, range 0 - 56, lower scores indicating better adherence

  33. Change in Quality of life score EQ-5D-5L after 18 months

    Time frame: 18 months

    Change in Quality of life score EQ-5D-5L is a standardised measure of health status developed by the EuroQol Group including 5 dimensions, 5 levels and the EQ visual analogue scale [VAS] from 0 to 100 with higher values indicating higher quality of life

  34. Change in Beliefs about Medicines Questionnaire (BMQ) after 18 months

    Time frame: 18 months

    The BMQ consists of two sections assessing personal beliefs about the necessity of prescribed medication (5 items) and concerns (5 items). Scores range from 5 to 25 with higher scores indicating a higher degree of necessity/concern.

  35. Incidence of major vascular events after 18 months

    Time frame: 18 months

    Incidence of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina or urgent coronary revascularization therapy after 18 months

  36. Change in highest degree of extracranial stenosis after 18 months

    Time frame: 18 months

    Change in highest degree of extracranial stenosis (%) as determined by carotid ultrasound using North American Carotid Endarterectomy Trial (NASCET) criteria after 18 months

  37. Change in maximum height of largest carotid plaque after 18 months

    Time frame: 18 months

    Change in maximum height of largest carotid plaque (mm) on carotid ultrasound after 18 months

  38. Change in longitudinal area of largest carotid plaque after 18 months

    Time frame: 18 months

    Change in longitudinal area of largest carotid plaque [mm2] on carotid ultrasound after 18 months

  39. Change in cross-sectional area of largest carotid plaque after 18 months

    Time frame: 18 months

    Change in cross-sectional area of largest carotid plaque [mm2] on carotid ultrasound after 18 months

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

University Hospital, Essen

Other

Registry information

Official study title

Improving Adherence to Statin Therapy Through a Medication Management Application (STAPP)

Acronym: STAPP

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Mar 21, 2023
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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