NCT05777655

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
30mo left

Started Feb 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Feb 2023Nov 2028

Study Start

First participant enrolled

February 17, 2023

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 21, 2023

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2028

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2028

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

5 years

First QC Date

February 22, 2023

Last Update Submit

April 28, 2026

Conditions

Atherosclerosis

Keywords

Smartphone ApplicationMedication Therapy Management

Outcome Measures

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

    6 months

Secondary Outcomes (39)

  • Modified Rankin Scale (mRS)-Score after 6 months

    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

    6 months

  • Relative change in total cholesterol after 6 months

    6 months

  • Relative change in hemoglobin A1C (HbA1c) after 6 months

    6 months

  • +34 more secondary outcomes

Study Arms (2)

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

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

Interventions

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

Medication management app

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Essen

Essen, North Rhine-Westphalia, 45147, Germany

RECRUITING

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Benedikt Frank, PD Dr.

CONTACT

+49 201benedikt.frank@uk-essen.de

Amir A Mahabadi, Prof. Dr.

CONTACT

+49 201Amir-Abbas.Mahabadi@uk-essen.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor (PD) Dr. med

Study Record Dates

First Submitted

February 22, 2023

First Posted

March 21, 2023

Study Start

February 17, 2023

Primary Completion (Estimated)

February 28, 2028

Study Completion (Estimated)

November 28, 2028

Last Updated

May 4, 2026

Record last verified: 2026-04

Locations

DE(1)