Improving Adherence to Statin Therapy Through a Medication Management Application
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Medication management app (mediteo m+, Mediteo GmbH, Heidelberg).
- Кому может быть актуально
- Состояния в реестре: Atherosclerosis. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Германия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Improving Adherence to Statin Therapy Through a Medication Management Application (STAPP)
Обзор
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.
Подробное описание
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.
Вмешательства
- Другое 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
Первичные конечные точки
- Relative change in LDL-C [Срок оценки: 6 months]
Вторичные конечные точки (12)
- Modified Rankin Scale (mRS)-Score after 6 months [Срок оценки: 6 months]
- Proportion of available LDL-C values measured by the family physician after 6 months [Срок оценки: 6 months]
- Relative change in high density lipoprotein-cholesterol (HDL-C) after 6 months [Срок оценки: 6 months]
- Relative change in total cholesterol after 6 months [Срок оценки: 6 months]
- Relative change in hemoglobin A1C (HbA1c) after 6 months [Срок оценки: 6 months]
- Relative change in high-sensitivity C-reactive protein (hsCRP) after 6 months [Срок оценки: 6 months]
- Relative change in Lipoprotein (a) after 6 months [Срок оценки: 6 months]
- Relative change in glutamic oxaloacetic transaminase (GOT) after 6 months [Срок оценки: 6 months]
- Relative change in glutamate-pyruvate transaminase (GPT) [Срок оценки: 6 months]
- Relative change in creatine kinase (CK) after 6 months [Срок оценки: 6 months]
- Adherence to statin therapy as measured by the German version of the Medication Adherence Report Scale (MARS-D) after 6 months [Срок оценки: 6 months]
- Adherence to statin therapy as measured by the German version of the A14 scale after 6 months [Срок оценки: 6 months]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Поддерживающая терапия
Центры проведения
Германия · 1 центр
- University Hospital, Essen — Essen
Идентификаторы
NCT: NCT05777655 · 21-10444