AtherosclerosisSTAPPNCT05777655
Improving Adherence to Statin Therapy Through a Medication Management Application
A study testing Medication management app (mediteo m+, Mediteo GmbH, Heidelberg) in people with Atherosclerosis, run by University Hospital, Essen at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- Medication management app (mediteo m+, Mediteo GmbH, Heidelberg)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteGermany
- Study dates
- 17 Feb 2023to 28 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital, Essen
Essen, North Rhine-Westphalia, 45147
Benedikt Frank, PD Dr., +49 201 ext. 723-6546, benedikt.frank@uk-essen.de
Benedikt Frank, PD Dr.
About this study
Official title: Improving Adherence to Statin Therapy Through a Medication Management Application (STAPP)
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.
Read the 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.
- Conditions
- Atherosclerosis
- Being tested
- Medication management app (mediteo m+, Mediteo GmbH, Heidelberg)
- Keywords
- Smartphone Application, Medication Therapy Management
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Medication management app | Experimental | 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 Receives: Other: Medication management app (mediteo m+, Mediteo GmbH, Heidelberg) |
| Standard of care | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change in LDL-C
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
Measured: 6 months
Secondary outcomes (39)
Modified Rankin Scale (mRS)-Score after 6 months
Change in mRS [0 to 6, higher scores indicating worse outcome] after 6 months
Measured: 6 months
Proportion of available LDL-C values measured by the family physician after 6 months
Proportion of available LDL-C values measured by the family physician after 6 months
Measured: 6 months
Relative change in high density lipoprotein-cholesterol (HDL-C) after 6 months
Relative change in HDL-C (mg/dl) after 6 months as compared to baseline-value
Measured: 6 months
Relative change in total cholesterol after 6 months
Relative change in total cholesterol (mg/dl) after 6 months as compared to baseline-value
Measured: 6 months
Relative change in hemoglobin A1C (HbA1c) after 6 months
Relative change in HbA1c (%) after 6 months as compared to baseline-value
Measured: 6 months
Relative change in high-sensitivity C-reactive protein (hsCRP) after 6 months
Relative change in hsCRP (mg/dl) after 6 months as compared to baseline-value
Measured: 6 months
Relative change in Lipoprotein (a) after 6 months
Relative change in Lipoprotein (a) (mg/dl) after 6 months as compared to baseline-value
Measured: 6 months
Relative change in glutamic oxaloacetic transaminase (GOT) after 6 months
Relative change in GOT (U/l) after 6 months as compared to baseline-value
Measured: 6 months
Relative change in glutamate-pyruvate transaminase (GPT)
Relative change in GPT (U/l) after 6 months as compared to baseline-value
Measured: 6 months
Relative change in creatine kinase (CK) after 6 months
Relative change in CK (U/l) after 6 months as compared to baseline-value
Measured: 6 months
Adherence to statin therapy as measured by the German version of the Medication Adherence Report Scale (MARS-D) after 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
Measured: 6 months
Adherence to statin therapy as measured by the German version of the A14 scale after 6 months
Measured by the German version of the A14 scale, range 0 - 56, lower scores indicating better adherence
Measured: 6 months
Change in Quality of life score EQ-5D-5L after 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
Measured: 6 months
Change in Beliefs about Medicines Questionnaire (BMQ) after 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.
Measured: 6 months
Incidence of major vascular events after 6 months
Incidence of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina or urgent coronary revascularization therapy after 6 months
Measured: 6 months
Change in highest degree of extracranial stenosis after 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
Measured: 6 months
Change in maximum height of largest carotid plaque after 6 months
Change in maximum height of largest carotid plaque (mm) on carotid ultrasound after 6 months
Measured: 6 months
Change in longitudinal area of largest carotid plaque after 6 months
Change in longitudinal area of largest carotid plaque [mm2] on carotid ultrasound after 6 months
Measured: 6 months
Change in cross-sectional area of largest carotid plaque after 6 months
Change in cross-sectional area of largest carotid plaque [mm2] on carotid ultrasound after 6 months
Measured: 6 months
Relative change in LDL-C after 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
Measured: 18 months
Modified Rankin Scale (mRS)-Score after 18 months
Change in mRS [0 to 6, higher scores indicating worse outcome] after 18 months
Measured: 18 months
Proportion of available LDL-C values measured by the family physician after 18 months
Proportion of available LDL-C values measured by the family physician after 18 months
Measured: 18 months
Relative change in high density lipoprotein-cholesterol (HDL-C) after 18 months
Relative change in HDL-C (mg/dl) after 18 months as compared to baseline-value
Measured: 18 months
Relative change in total cholesterol after 18 months
Relative change in total cholesterol (mg/dl) after 18 months as compared to baseline-value
Measured: 18 months
Relative change in hemoglobin A1C (HbA1c) after 18 months
Relative change in HbA1c (%) after 18 months as compared to baseline-value
Measured: 18 months
Relative change in high-sensitivity C-reactive protein (hsCRP) after 18 months
Relative change in hsCRP (mg/dl) after 18 months as compared to baseline-value
Measured: 18 months
Relative change in Lipoprotein (a) after 18 months
Relative change in Lipoprotein (a) (mg/dl) after 18 months as compared to baseline-value
Measured: 18 months
Relative change in glutamic oxaloacetic transaminase (GOT) after 18 months
Relative change in GOT (U/l) after 18 months as compared to baseline-value
Measured: 18 months
Relative change in glutamate-pyruvate transaminase (GPT) after 18 months
Relative change in GPT (U/l) after18 months as compared to baseline-value
Measured: 18 months
Relative change in creatine kinase (CK) after 18 months
Relative change in CK (U/l) after 18 months as compared to baseline-value
Measured: 18 months
Adherence to statin therapy as measured by the German version of the Medication Adherence Report Scale (MARS-D) after 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
Measured: 18 months
Adherence to statin therapy as measured by the German version of the A14 scale after 18 months
Measured by the German version of the A14 scale, range 0 - 56, lower scores indicating better adherence
Measured: 18 months
Change in Quality of life score EQ-5D-5L after 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
Measured: 18 months
Change in Beliefs about Medicines Questionnaire (BMQ) after 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.
Measured: 18 months
Incidence of major vascular events after 18 months
Incidence of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina or urgent coronary revascularization therapy after 18 months
Measured: 18 months
Change in highest degree of extracranial stenosis after 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
Measured: 18 months
Change in maximum height of largest carotid plaque after 18 months
Change in maximum height of largest carotid plaque (mm) on carotid ultrasound after 18 months
Measured: 18 months
Change in longitudinal area of largest carotid plaque after 18 months
Change in longitudinal area of largest carotid plaque [mm2] on carotid ultrasound after 18 months
Measured: 18 months
Change in cross-sectional area of largest carotid plaque after 18 months
Change in cross-sectional area of largest carotid plaque [mm2] on carotid ultrasound after 18 months
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start17 Feb 2023
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benedikt Frank, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05777655
- Sponsor's protocol ID
- 21-10444
- Acronym
- STAPP
- Status last verified
- Apr 2026
- First submitted
- 22 Feb 2023
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Adherence to Statin Therapy Through a Medication Management Application (STAPP)
- ClinicalTrials.gov ID
- NCT05777655
- Acronym / sponsor ID
- STAPP / 21-10444
- Conditions
- Atherosclerosis
- Keywords
- Smartphone Application, Medication Therapy Management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Nov 2028 (estimated)
- First posted
- 21 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medication management app | Experimental | Other: Medication management app (mediteo m+, Mediteo GmbH, Heidelberg)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 |
| Standard of care | No intervention | –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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Medication management app |
Primary outcome
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
39 secondary outcomes
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
Change in Quality of life score EQ-5D-5L after 6 months
Time frame: 6 months
Change in Beliefs about Medicines Questionnaire (BMQ) after 6 months
Time frame: 6 months
Incidence of major vascular events after 6 months
Time frame: 6 months
Change in highest degree of extracranial stenosis after 6 months
Time frame: 6 months
Change in maximum height of largest carotid plaque after 6 months
Time frame: 6 months
Change in longitudinal area of largest carotid plaque after 6 months
Time frame: 6 months
Change in cross-sectional area of largest carotid plaque after 6 months
Time frame: 6 months
Relative change in LDL-C after 18 months
Time frame: 18 months
Modified Rankin Scale (mRS)-Score after 18 months
Time frame: 18 months
Proportion of available LDL-C values measured by the family physician after 18 months
Time frame: 18 months
Relative change in high density lipoprotein-cholesterol (HDL-C) after 18 months
Time frame: 18 months
Relative change in total cholesterol after 18 months
Time frame: 18 months
Relative change in hemoglobin A1C (HbA1c) after 18 months
Time frame: 18 months
Relative change in high-sensitivity C-reactive protein (hsCRP) after 18 months
Time frame: 18 months
Relative change in Lipoprotein (a) after 18 months
Time frame: 18 months
Relative change in glutamic oxaloacetic transaminase (GOT) after 18 months
Time frame: 18 months
Relative change in glutamate-pyruvate transaminase (GPT) after 18 months
Time frame: 18 months
Relative change in creatine kinase (CK) after 18 months
Time frame: 18 months
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 as measured by the German version of the A14 scale after 18 months
Time frame: 18 months
Change in Quality of life score EQ-5D-5L after 18 months
Time frame: 18 months
Change in Beliefs about Medicines Questionnaire (BMQ) after 18 months
Time frame: 18 months
Incidence of major vascular events after 18 months
Time frame: 18 months
Change in highest degree of extracranial stenosis after 18 months
Time frame: 18 months
Change in maximum height of largest carotid plaque after 18 months
Time frame: 18 months
Change in longitudinal area of largest carotid plaque after 18 months
Time frame: 18 months
Change in cross-sectional area of largest carotid plaque after 18 months
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication management app (mediteo m+, Mediteo GmbH, Heidelberg) in people with Atherosclerosis, run by University Hospital, Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benedikt Frank, PD Dr. (+49 201 ext. 723-6546, benedikt.frank@uk-essen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative change in LDL-C (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.