Идёт набор NCT06847633

A Digital Lifestyle Intervention in Primary Healthcare to Prevent Cardiovascular Disease

Без фазы С лечением Cardiovascular Diseases Lifestyle Factors

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: Digital lifestyle intervention.
Кому может быть актуально: Состояния в реестре: Cardiovascular Diseases, Lifestyle Factors. Базовые параметры: 39 лет — 61 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: Швеция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Unhealthy lifestyle behaviors are well-established risk factors for cardiovascular disease (CVD) which is the leading cause of death globally and in Sweden. Digitalization offers new and better possibilities for healthcare to fulfil their responsibility to support healthier lifestyles, however, to ensure scalability and sustained implementation of digital tools within healthcare, digital interventions need to be systematically maintained and delivered by the primary healthcare. The aim of this project is to evaluate whether a digital lifestyle intervention, developed within Swedish primary healthcare, can improve clinically important cardiovascular health outcomes and lifestyle behaviors. In this multi-center randomized controlled trial patients, 40-60 years, in Swedish primary healthcare will be recruited and randomized to the control or intervention group. All participants will receive standard care consisting of one structured health dialogue focused on lifestyle habits. The intervention group will also receive support through the digital lifestyle intervention for creating healthy habits regarding diet, physical activity, alcohol consumption, and tobacco usage. The primary outcome is LDL-cholesterol at 6 months post-randomization. Secondary outcomes 6 months post-randomization are HDL-, total cholesterol, fasting blood glucose, triglycerides, non-HDL, blood pressure, weight, height, BMI, waist circumference, cardiovascular risk evaluation (SCORE2), dietary intake, physical activity, sleep, stress, alcohol consumption, tobacco use, and health-related quality of life.

Вмешательства

Поведенческое Digital lifestyle intervention
The digital lifestyle intervention provides support to the patient through digital lectures, home assignments and digital group meetings as well as provides the possibility for the healthcare provider to provide personalized digital support and feedback to the patient

Первичные конечные точки

LDL-cholesterol [Срок оценки: 6 months post-randomization]

Вторичные конечные точки (12)

HDL-cholesterol [Срок оценки: 6 months post-randomization]
Total cholesterol [Срок оценки: 6 months post-randomization]
Fasting blood glucose [Срок оценки: 6 months post-randomization]
Triglycerides [Срок оценки: 6 months post-randomization]
Non-HDL cholesterol [Срок оценки: 6 months post-randomization]
Systolic blood pressure [Срок оценки: 6 months post-randomization]
Diastolic blood pressure [Срок оценки: 6 months post-randomization]
Weight [Срок оценки: 6 months post-randomization]
Height [Срок оценки: 6 months post-randomization]
Body mass index [Срок оценки: 6 months post-randomization]
Waist circumference [Срок оценки: 6 months post-randomization]
Systematic COronary Risk Evaluation model, second version (SCORE2) [Срок оценки: 6 months post-randomization]

Критерии участия

Критерии включения

Attended a Health dialogue visit to primary healthcare for patients 40-60 years old
Willing to change at least one lifestyle behavior regarding physical activity, diet, smoking/snus, alcohol, sleep, or stress