Health TrialsbyHealthPanel

Improving Adherence to Statin Therapy Through a Medication Management Application

ConditionAtherosclerosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Essen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Other intervention

    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

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Medication management appExperimental treatment 1 intervention
Group B: Standard of careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
6 months

Secondary outcomes

1

Modified Rankin Scale (mRS)-Score after 6 months

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

Time frame
6 months
2

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

Time frame
6 months
3

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

Time frame
6 months
4

Relative change in total cholesterol after 6 months

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

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Essen

Lead sponsor

Source ClinicalTrials.gov
Apply now