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Набор по приглашению NCT06593704

Proactive Population Health Management of Cardiovascular Disease in Primary Care Using the PROSPERA-program.

Без фазы С лечением Cardiovascular Diseases

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: PROSPERA-program.
Кому может быть актуально
Состояния в реестре: Cardiovascular Diseases. Базовые параметры: 40 лет — 90 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
Нидерланды
Следующий шаг
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Официальное название

Proactive Population Health Management of Cardiovascular Disease in Primary Care Using a Multilevel Guideline Adherence Toolkit (the PROSPERA-program).

Обзор

The PROSPERA-program is a complex multilevel approach that includes training for healthcare providers, a risk assessment process, and decision support tools to help match patients with the appropriate treatment based on their care needs. The goal of this clinical trial is to determine if the PROSPERA-program can improve the cardiovascular risk profile in patients aged 40-90 years enrolled in primary care programs for increased cardiovascular risk, such as cardiovascular disease, increased vascular risk, or diabetes. The main question it aims to answer is: • Does the cardiovascular risk profile improve for patients using the PROSPERA-program? Researchers will compare the PROSPERA-program with standard cardiovascular care to see if the program enhances cardiovascular population health in primary care. Additionally, the study will assess how well the PROSPERA-program fits into the workflow of primary care providers and supports shared decision-making. Participants will: * Receive a consultation with their general practitioner or practice nurse according to the PROSPERA-program. * Have their routinely collected healthcare data used for evaluation. * Be asked to complete a questionnaire or participate in an interview (for a subset of patients).

Вмешательства

  • Другое PROSPERA-program
    The PROSPERA-program consists of the following components: 1. Health care provider training and education about U-Prevent and cardiovascular risk communication. 2. Risk stratification: proactive selection of cardiovascular patients through the PROSPERA-empanelment procedure - for the population with increased cardiovascular risk, prior to consultation. 3. Decision support tools: use of the Lifestylecheck and the U-Prevent clinical decision support tool to guide motivated shared decision making

Первичные конечные точки

  • The proportion of individuals who have achieved all protocol-defined cardiovascular prevention goals. [Срок оценки: At 0 and 18 months]
Вторичные конечные точки (8)
  • Perceived shared decision making (in subset only) [Срок оценки: immediately after the intervention]
  • Perceived shared decision making (in subset only) [Срок оценки: immediately after the intervention]
  • Decisional Conflict (in subset only) [Срок оценки: immediately after the intervention]
  • Implementation outcome: fidelity [Срок оценки: At month 4 and 10]
  • Implementation outcome: fidelity [Срок оценки: At month 4 and 10]
  • Implementation outcome: penetration [Срок оценки: At month 10]
  • Healthcare professional's satisfaction on usability of the PROSPERA-program [Срок оценки: At month 10]
  • Cost-effectiveness [Срок оценки: immediately after the intervention and at month 18]

Критерии участия

Критерии включения

  • Age > 40 years and ≤ 90 years
  • Patient in a primary care practice enrolled in this study
  • Included in the cardiovascular disease (CVD), increased vascular risk (IVR) or diabetes mellitus (DM) Dutch Integrated Care programs
  • Additional criteria for subgroup that receives questionnaires: able to communicate in the Dutch and/or English language

Критерии исключения

  • Patients with Diabetes Mellitus type I
  • Patients receiving palliative care
  • Patients with any form of cognitive impairment diseases such as Dementia or Alzheimer
  • Patients who are treated in other Integrated Care programs because of their frailty (e.g. elderly who are treated in the 'Kwetsbare Ouderen Chronische Zorgprogramma')

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
Открытое
Основная цель
Профилактика

Центры проведения

Нидерланды · 1 центр
  • Department of Public Health and Primary Care — The Hague

Идентификаторы

NCT: NCT06593704 · 23-3050 · 10140302110018

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗