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Идёт набор NCT07275931

Digital Support Program for Patients With Heart Failure - a Cluster-Randomized Hybrid Type 2 Study

Без фазы С лечением Heart Failure With Reduced Ejection Fraction

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: Tailored implementation support.
Кому может быть актуально
Состояния в реестре: Heart Failure With Reduced Ejection Fraction. 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
Швеция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Digital Support Program Via 1177 for Patients With Heart Failure - a Cluster-Randomized Hybrid Type 2 Study for Evaluation of Effects and Implementation

Обзор

The overall aim of this project is to evaluate the effects of a digital support program for patients with heart failure through a cluster-randomized controlled trial, and to investigate the outcomes of different implementation strategies using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance), PRISM (Practical, Robust Implementation and Sustainability Model) and ERIC (Expert Recommendations for Implementing Change) framework. Our primary hypothesis is that the digital support program will improve patients' perceived control over their heart failure, measured with the validated Control Attitude Scale. Secondary hypotheses are that the program will increase patients' health-related quality of life, self-care behaviors, heart failure knowledge, perceived continuity of care, and participation in care, and reduce symptoms of depression. Implementation aim (based on the RE-AIM, PRISM and ERIC frameworks) The implementation component of the study aims to compare two different implementation strategies: a standard (basic) support package versus a tailored, context-specific support strategy. Heart failure clinics at hospitals an within primary care will be matched and randomized into two arms. The intervention arm will receive tailored implementation support to implement the support program. The control arm will recive implementation support according to a predefined standard procedure. Researchers will compare the intervention arm with control arm to see if there are any differences regarding the implementationsuccess between the arms. The patients in both arms will have access to the support program during six months.

Подробное описание

Will be added

Вмешательства

  • Другое Tailored implementation support
    Tailored implementation support

Первичные конечные точки

  • Perceived control attitudes [Срок оценки: At enrollment and at the end of the intervention at 6 month]
Вторичные конечные точки (9)
  • Self-care [Срок оценки: At enrollment and at the end of the intervention at 6 month]
  • Perceived control [Срок оценки: At enrollment and at the end of the intervention at 6 month]
  • Heart failure knowledge [Срок оценки: At enrollment and at the end of the intervention at 6 month]
  • Healthcare consumtion [Срок оценки: From enrollment to 12 month follow-up]
  • Health related quality of life [Срок оценки: At enrollment and at the end of the intervention at 6 month]
  • Disease specific health-related quality of life [Срок оценки: At enrollment and at the end of the intervention at 6 month]
  • Symptoms of Depression [Срок оценки: At enrollment and at the end of the intervention at 6 month]
  • Continuity of care [Срок оценки: At enrollment and at the end of the intervention at 6 month]
  • Electronic Health Literacy [Срок оценки: At enrollment and at the end of the intervention at 6 month]

Критерии участия

Критерии включения

  • Diagnosed with heart failure with reduced ejection fraction (HFrEF) or heart failure with midrange reduced ejection fraction (HFmrEF) (ejection fraction ≤50%) verified by echocardiography or Magnetic Resonance Imaging
  • Access to BankID, a computer, tablet, or smartphone
  • Aged ≥18 years
  • Able to understand and communicate in Swedish
  • Provided informed consent

Критерии исключения

  • Barriers to participation (e.g., not Swedish-speaking, cognitive impairment, severe mental illness, substance abuse)
  • Life expectancy of less than six months

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
Поддерживающая терапия

Центры проведения

Швеция · 1 центр
  • Linköping University Hospital — Linköping

Идентификаторы

NCT: NCT07275931 · 2023-04289-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗