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Enrolling by Invitation

NCT Number: NCT07240714

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

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).

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Key information

Conditions

Cardiac Arrest (CA) Anxiety Disorders Behavior Behavioral Symptoms Cardiovascular Diseases Depression Fatigue Heart Arrest Heart Diseases Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept of Cardiology, Linköping, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Digital Support Programme

Behavioral

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 according to their individual needs. The programme is delivered entirely online and does not require any physical visits or clinical procedures.

Primary outcomes

  1. Change from Baseline in Overall Wellbeing at 3 months.

    Time frame: From baseline to 3 months after enrollment.

    The Questionnaire on Well-Being is a tool designed to capture subjective well-being. It consists of 18 questions, each rated from 0 to 4, which are added together to give a total score between 0 and 72. Higher scores reflect greater perceived well-being, while scores below 50 have been linked to significant psychological distress.

Secondary outcomes

  1. Change from Baseline in Quality of Life at 3 and 6 months.

    Time frame: From baseline to 3 and 6 months after enrollment.

    Change from baseline in Quality of Life (EuroQol Five-Dimension Five-Level questionnaire, EQ-5D-5L).

    Score range: 0 to 1 (index value). Higher scores indicate better quality of life.

    Change from baseline in Quality of Life (EuroQol Visual Analogue Scale). Score range: 0 to 100. Higher scores indicate better self-rated health.

    Outcomes will be analyzed both as change from baseline to each time point (3 and 6 months), and as within-subject change between the 3- and 6-months assessments to evaluate sustained or delayed effects of the intervention.

  2. Change from baseline in Life Satisfaction at 3 and 6 months.

    Time frame: From baseline to 3 and 6 months after enrollment.

    Change from baseline in Life Satisfaction (Life Satisfaction Questionnaire, LiSat-11) at 3 and 6 months.

    Score range: 11 to 66. Higher scores indicate greater life satisfaction. Outcomes will be analyzed both as change from baseline to each time point (3 and 6 months), and as within-subject change between the 3- and 6-months assessments to evaluate sustained or delayed effects of the intervention.

  3. Change from baseline in Anxiety at 3 and 6 months.

    Time frame: From baseline to 3 and 6 months after enrollment.

    Change from baseline in Anxiety (Generalised Anxiety Disorder 7-item scale, GAD-7) at 3 and 6 months.

    Score range: 0 to 21. Higher scores indicate more severe anxiety symptoms.

    Outcomes will be analyzed both as change from baseline to each time point (3 and 6 months), and as within-subject change between the 3- and 6-months assessments to evaluate sustained or delayed effects of the intervention.

  4. Change from baseline in Depression at 3 and 6 months.

    Time frame: From baseline to 3 and 6 months after enrollment.

    Change from baseline in Depression (Patient Health Questionnaire 9-item scale, PHQ-9) at 3 and 6 months. Score range: 0 to 27. Higher scores indicate more severe depressive symptoms.

    Outcomes will be analyzed both as change from baseline to each time point (3 and 6 months), and as within-subject change between the 3- and 6-months assessments to evaluate sustained or delayed effects of the intervention.

  5. Change from baseline in Post-Traumatic Stress at 3 and 6 months.

    Time frame: From baseline to 3 and 6 months after enrollment.

    Change from baseline in Post-Traumatic Stress (Impact of Event Scale - Revised, IES-R) at 3 and 6 months. Score range: 0 to 88. Higher scores indicate more severe post-traumatic stress symptoms.

    Outcomes will be analyzed both as change from baseline to each time point (3 and 6 months), and as within-subject change between the 3- and 6-months assessments to evaluate sustained or delayed effects of the intervention.

  6. Change from baseline in Fatigue at 3 and 6 months.

    Time frame: From baseline to 3 and 6 months after enrollment.

    Change from baseline in Fatigue (Modified Fatigue Impact Scale, MFIS-21) at 3 and 6 months. Score range: 0 to 84. Higher scores indicate greater impact of fatigue.

    Outcomes will be analyzed both as change from baseline to each time point (3 and 6 months), and as within-subject change between the 3- and 6-months assessments to evaluate sustained or delayed effects of the intervention.

  7. Change from baseline in Sleep at 3 and 6 months.

    Time frame: From baseline to 3 and 6 months after enrollment.

    Change from baseline in Sleep (Minimal Insomnia Symptom Scale, MISS) at 3 and 6 months. Score range: 0 to 12. Higher scores indicate more severe insomnia symptoms.

    Outcomes will be analyzed both as change from baseline to each time point (3 and 6 months), and as within-subject change between the 3- and 6-months assessments to evaluate sustained or delayed effects of the intervention.

  8. Change from baseline in Cognitive Function at 3 and 6 months.

    Time frame: From baseline to 3 months after enrollment.

    Change from baseline in Cognitive Function (single-item question on perceived cognitive difficulties) at 3 and 6 months. Score range: 1 to 5. Higher scores indicate greater perceived cognitive impairment.

    Outcomes will be analyzed both as change from baseline to each time point (3 and 6 months), and as within-subject change between the 3- and 6-months assessments to evaluate sustained or delayed effects of the intervention.

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Registry information

Official study title

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

Acronym: CARDIS

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 21, 2025
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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