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

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.

Study Overview

• Status: Recruiting
• Conditions: Atherosclerosis
• Intervention / Treatment: Other: Medication management app (mediteo m+, Mediteo GmbH, Heidelberg)

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 Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Benedikt Frank, PD Dr.; Phone Number: 723-6546 +49 201; Email: benedikt.frank@uk-essen.de
• Study Contact Backup: Name: Amir A Mahabadi, Prof. Dr.; Phone Number: 723-4848 +49 201; Email: Amir-Abbas.Mahabadi@uk-essen.de

Study Locations

• Germany
  • Nordrhein-Westfalen
    • Essen, Nordrhein-Westfalen, Germany, 45147
      • Recruiting
      • University Hospital, Essen
      • Contact: Benedikt Frank, PD Dr.; Phone Number: 723-6546 +49 201; Email: benedikt.frank@uk-essen.de
      • Principal Investigator: Benedikt Frank, PD Dr.
      • Sub-Investigator: Amir A Mahabadi, Prof Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Medication management app; 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	Other: 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
No Intervention: Standard of care; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Rankin Scale (mRS)-Score after 6 months	Change in mRS [0 to 6, higher scores indicating worse outcome] after 6 months	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	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	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	6 months
Relative change in hemoglobin A1C (HbA1c) after 6 months	Relative change in HbA1c (%) after 6 months as compared to baseline-value	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	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	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	6 months
Relative change in glutamate-pyruvate transaminase (GPT)	Relative change in GPT (U/l) after 6 months as compared to baseline-value	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	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	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	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	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.	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	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	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	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	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	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	18 months
Modified Rankin Scale (mRS)-Score after 18 months	Change in mRS [0 to 6, higher scores indicating worse outcome] after 18 months	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	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	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	18 months
Relative change in hemoglobin A1C (HbA1c) after 18 months	Relative change in HbA1c (%) after 18 months as compared to baseline-value	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	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	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	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	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	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	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	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	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.	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	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	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	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	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	18 months

Collaborators and Investigators

• Sponsor: University Hospital, Essen

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2023
• Primary Completion (Anticipated): February 28, 2025
• Study Completion (Anticipated): February 28, 2027

Study Registration Dates

• First Submitted: February 22, 2023
• First Submitted That Met QC Criteria: March 8, 2023
• First Posted (Actual): March 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 8, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Medication Therapy Management; Smartphone Application
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis
• Other Study ID Numbers: 21-10444

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No