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Набор по приглашению NCT07240714

Effects of an Web-based Support Programme for Cardiac Arrest Survivors

Без фазы С лечением Cardiac Arrest (CA)

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 Support Programme.
Кому может быть актуально
Состояния в реестре: Cardiac Arrest (CA). 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 →
Официальное название

Effects of a Web-based Support Programme for Cardiac Arrest Survivors: A Randomized Controlled Trial With Process Evaluation (The CARDIS Study)

Обзор

The overall goal of this clinical trial is to learn if a web-based support programme can improve wellbeing in cardiac arrest survivors by helping them manage emotional, cognitive, and physical challenges. The study also explores how the programme is used and experienced in practice. The main questions it aims to answer are: * Can access to a web-based support programme improve overall wellbeing in cardiac arrest survivors? * Can it also enhance quality of life, cognitive function, life satisfaction, and sleep, while reducing anxiety, depression, post-traumatic stress, and fatigue? Researchers will compare cardiac arrest survivors who receive a web-based support programme in addition to standard care with those who receive standard care alone, to see if the programme improves wellbeing and other health outcomes. After the study, the control group will also gain access to the programme. Participants will: * Be asked to complete online questionnaires at three time points: at the start of the study, after 3 months, and after 6 months. * Be encouraged to use a web-based support programme for 3 months, with unlimited access, at their own pace and according to their individual needs (intervention group only).

Подробное описание

Cardiac arrest is a serious public health issue, affecting around 13,000 people annually in Sweden. Survivors often face long-term physical, cognitive, and emotional challenges, including anxiety, depression, fatigue, sleep disturbances, and post-traumatic stress. These difficulties can significantly impact daily life, and many survivors struggle to return to work or previous routines.

Although guidelines recommend follow-up within 1-3 months after hospital discharge, support is often fragmented and varies across regions. Survivors frequently report limited access to reliable information and emotional support. Research has shown that structured education and rehabilitation are essential for both survivors and their families, yet current care models rarely address these needs in a comprehensive way.

To help fill this gap, a web-based support programme was co-created in 2024-2025 by researchers, healthcare professionals, cardiac arrest survivors, and patient organizations. The programme includes educational modules, patient and family stories, videos, practical exercises, and tools for self-management and personal recovery planning. It also features a moderated chat forum for peer support. A feasibility study showed that the programme was easy to use and perceived as relevant and helpful.

The study begins with a pilot phase (n=10) to test study procedures, followed by a randomized controlled trial (RCT) with 120 participants across eight Swedish regions. Participants are recruited during routine follow-up visit one month after discharge. All participants receive standard care. Those randomized to the intervention group gain access to the digital support programme for 12 weeks. The control group receives standard care and gains access to the programme after study completion.

Consent and data collection are handled digitally. Participants are asked to complete online surveys at baseline, 3 months, and 6 months. These surveys cover wellbeing, quality of life, sleep, fatigue, emotional health, and cognitive function. The study also collects usage data from the programme to understand how participants engage with the content. No physical tests or extra clinic visits are required.

The study aims to generate new knowledge about how digital tools can support recovery after cardiac arrest, improve wellbeing, and reduce healthcare burden by offering accessible, person-centered rehabilitation.

Вмешательства

  • Поведенческое Digital Support Programme
    The intervention consists of a web-based support programme designed for individuals recovering from cardiac arrest. Participants in the intervention group receive access to the programme for 12 weeks. The programme includes educational modules, patient and family stories, videos, practical exercises (e.g., breathing techniques, fatigue management), tools for personal recovery planning, and a moderated chat forum for peer support. Participants can access the content at their own pace and accordin

Первичные конечные точки

  • Change from Baseline in Overall Wellbeing at 3 months. [Срок оценки: From baseline to 3 months after enrollment.]
Вторичные конечные точки (8)
  • Change from Baseline in Quality of Life at 3 and 6 months. [Срок оценки: From baseline to 3 and 6 months after enrollment.]
  • Change from baseline in Life Satisfaction at 3 and 6 months. [Срок оценки: From baseline to 3 and 6 months after enrollment.]
  • Change from baseline in Anxiety at 3 and 6 months. [Срок оценки: From baseline to 3 and 6 months after enrollment.]
  • Change from baseline in Depression at 3 and 6 months. [Срок оценки: From baseline to 3 and 6 months after enrollment.]
  • Change from baseline in Post-Traumatic Stress at 3 and 6 months. [Срок оценки: From baseline to 3 and 6 months after enrollment.]
  • Change from baseline in Fatigue at 3 and 6 months. [Срок оценки: From baseline to 3 and 6 months after enrollment.]
  • Change from baseline in Sleep at 3 and 6 months. [Срок оценки: From baseline to 3 and 6 months after enrollment.]
  • Change from baseline in Cognitive Function at 3 and 6 months. [Срок оценки: From baseline to 3 months after enrollment.]

Критерии участия

Критерии включения

  • Age 18 years or older
  • Survival of a cardiac arrest 1 to 3 months prior to enrollment
  • Access to a mobile phone, tablet, or computer with internet connection

Критерии исключения

  • Insufficient language or cognitive ability to engage with a digital intervention and complete questionnaires in Swedish
  • Participation in another study involving the collection of patient-reported outcome measures (PROMs)

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

Швеция · 3 центра
  • Dept of Cardiology — Linköping
  • Dept of Cardiology — Motala
  • Dept of Cardiology — Norrköping

Публикации

  • Waldemar A, Israelsson J, Heimburg K, Blennow Nordstrom E, Nordberg P, Bremer A, Arestedt K, Thylen I. CARDIS (Cardiac ARrest DIgital Support): study protocol for a randomised controlled trial of a web-based support intervention for cardiac arrest survivors. Resusc Plus. 2026 Jan 18;28:101235. doi: 10.1016/j.resplu.2026.101235. eCollection 2026 Mar. PMID 41674709

Идентификаторы

NCT: NCT07240714 · 2025-06113-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗