CARDIS (Cardiac ARrest DIgital Support): study protocol for a randomised controlled trial of a web-based support
Annette Waldemar1,2, Johan Israelsson3,4, Katarina Heimburg5,6
1Department of Health, Medicine, and Caring Sciences, Linköping University, Linköping, Sweden.
Insights
The CARDIS trial tests a digital support program for cardiac arrest survivors to improve wellbeing and self-management. This intervention aims to enhance long-term recovery and quality of life by addressing common post-cardiac arrest challenges.
Area of Science:
- Cardiology
- Digital Health Interventions
- Patient Recovery and Rehabilitation
Background:
- Sudden cardiac arrest survivors often face persistent cognitive, emotional, and physical challenges.
- Current clinical guidelines for structured post-cardiac arrest follow-up are frequently inconsistent or unavailable.
- Digital interventions offer a potential solution to bridge gaps in post-cardiac arrest care.
Purpose of the Study:
- To evaluate the effectiveness of a co-created, web-based support program (CARDIS) for cardiac arrest survivors.
- To improve patient-reported outcomes, including wellbeing, self-management, and reintegration into daily life.
- To assess the feasibility and impact of a digital intervention within existing healthcare structures.
Main Methods:
- A multicentre, randomized controlled trial (RCT) involving adult cardiac arrest survivors.
- Participants randomized 1:1 to receive standard care plus a 3-month web-based support program or standard care alone.
- Standard care includes routine follow-up visits and a printed booklet; the intervention group receives additional digital access.
Main Results:
- The primary outcome is overall wellbeing and health (QWB) at 3 months post-intervention.
- Secondary outcomes measure cognitive function, health-related quality of life (HRQoL), life satisfaction, and mental health symptoms (depression, anxiety, PTSD).
- A process evaluation will examine adherence, participant experiences, and potential social selection bias.
Conclusions:
- The CARDIS trial aims to establish more accessible and standardized follow-up pathways for cardiac arrest survivors.
- The intervention seeks to enhance long-term recovery and quality of life without increasing healthcare resource utilization.
- Findings will inform the future implementation of digital support programs for this patient population.
Background:
Surviving sudden cardiac arrest often lead to long-term cognitive, emotional, and physical consequences. Although clinical guidelines recommend structured post-cardiac arrest follow-up, such follow-up is often lacking or inconsistent. Tailored digital interventions are scarce but may help address gaps in follow-up resources. The CARDIS trial evaluates the effects on patient-reported outcome measures of a co-created, web-based support programme designed to improve wellbeing, self management, and reintegration into everyday life for cardiac arrest survivors.
Methods:
CARDIS is a multicentre, parallel-group, randomised controlled trial enrolling cardiac arrest survivors aged >18 years. Participants will be randomised 1:1 to intervention or control. Both groups will receive standard post-cardiac arrest care, including a routine followup visit with screening and management of cognitive, physical and emotional health, as well as a printed booklet. The intervention group will additionally receive access to a webbased selfguided support programme for 3 months. After study completion, control participants will be offered the programme.
Outcomes:
Primary outcome is overall wellbeing and health (QWB) at 3 months. Secondary outcomes include self-reported cognitive problems, HRQoL, life satisfaction, symptoms of depression and anxiety, post-traumatic stress, fatigue, and sleep disturbances. A process evaluation will evaluate social selection bias, adherence and participants experiences.
Discussion:
The CARDIS trial will investigate the use of more accessible and standardised follow-up pathways by complementing existing care structures, thereby enhancing equity in long-term recovery and quality-of-life without requiring additional healthcare resources. The process evaluation will provide data on adherence, social selection, and engagement, essential for future implementation.Trial registration: The trial is registered at clinicaltrials.gov (NCT07240714).
Related Concept Videos
01:28Self-Help Support Groups
Accessibility and Cost-Effectiveness
One of the primary strengths of self-help...
01:30Support Reactions
The purpose of the supports is to prevent the translational motion of the system by applying an equal and opposite force and to prevent the system's rotation by applying...
01:27Support Reactions in Three Dimensions
Ball and Socket Joint is one of the supports allowing free rotation about any axis. This freedom of rotation is...
01:20Blood Studies for Cardiovascular System I: Cardiac Biomarkers
The essential diagnostic tools for detecting myocardial necrosis and monitoring individuals suspected of having acute coronary syndrome (ACS) include:
Troponins
Troponins, particularly cardiac troponins I and T, are the most precise and sensitive markers of myocardial injury. They are detectable within 4-6 hours of myocardial injury and remain...
01:22Cardiac Output II: Effect of Stroke Volume on Cardiac Output
Preload
Preload refers to the initial elongation of the cardiac myocytes before contraction and is related to the volume of blood filling the heart at the end of diastole, or end-diastolic volume. The...
01:23Bone as Supporting Connective Tissue
Bone Matrix
Bone, or osseous tissue, is a connective tissue that has a large amount of two different types of matrix material. The organic matrix is similar to the matrix material found in other connective tissues, including some amount of collagen and elastic fibers. This gives strength and flexibility to the tissue. The inorganic matrix consists of mineral salts— mostly calcium salts—...