Cardiac Arrest (CA)CARDISNCT07240714
Effects of a Web-based Support Programme for Cardiac Arrest Survivors
A study testing Digital Support Programme in people with Cardiac Arrest (CA), run by Linkoeping University at 9 sites in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest (CA)
- What is being tested?
- Digital Support Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 9 sitesSweden
- Study dates
- 20 Nov 2025to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
Sweden9 sites
Sahlgrenska Universitetssjukhuset
Gothenburg
Östra sjukhuset
Gothenburg
Helsingborgs lasarett
Helsingborg
Länssjukhuset
Kalmar
Universitetssjukhuset
Linköping
Skånes universitetssjukhus
Lund
Lasarettet i Motala
Motala
Vrinnevisjukhuset
Norrköping
Västmanlands sjukhus Västerås
Västerås
About this study
Official title: Effects of a Web-based Support Programme for Cardiac Arrest Survivors: A Randomized Controlled Trial With Process Evaluation (The CARDIS Study)
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:
Read more
- 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).
Read the detailed description
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 six 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.
- Conditions
- Cardiac Arrest (CA)
- Being tested
- Digital Support Programme
- Keywords
- Cardiac arrest, Digital support programme, Web-based intervention, Mental wellbeing, Quality of life, Fatigue, Cognitive function, Anxiety and depression, Post-traumatic stress, Randomized controlled trial, co-creation
- Medical subject headings
- Heart Arrest, Fatigue, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Support ProgrammeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Web-Based Support Programme for Cardiac Arrest Survivors | Experimental | Not described Receives: Behavioral: Digital Support Programme |
| Waitlist Control (Standard Care + Delayed Access) | No intervention | Participants in this arm receive standard follow-up care according to national guidelines. They do not have access to the digital support programme during the study period. However, they are placed on a waitlist and are offered access to the programme after study completion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Overall Wellbeing at 3 months.
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.
Measured: From baseline to 3 months after enrollment.
Secondary outcomes (8)
Change from Baseline in Quality of Life at 3 and 6 months.
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.
Measured: From baseline to 3 and 6 months after enrollment.
Change from baseline in Life Satisfaction at 3 and 6 months.
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.
Measured: From baseline to 3 and 6 months after enrollment.
Change from baseline in Anxiety at 3 and 6 months.
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.
Measured: From baseline to 3 and 6 months after enrollment.
Change from baseline in Depression at 3 and 6 months.
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.
Measured: From baseline to 3 and 6 months after enrollment.
Change from baseline in Post-Traumatic Stress at 3 and 6 months.
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.
Measured: From baseline to 3 and 6 months after enrollment.
Change from baseline in Fatigue at 3 and 6 months.
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.
Measured: From baseline to 3 and 6 months after enrollment.
Change from baseline in Sleep at 3 and 6 months.
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.
Measured: From baseline to 3 and 6 months after enrollment.
Change from baseline in Cognitive Function at 3 and 6 months.
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.
Measured: From baseline to 3 months after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start20 Nov 2025
- Primary completion31 May 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Arrest (CA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ingela Thylén, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07240714
- Sponsor's protocol ID
- 2025-06113-01
- Other IDs
- 2025
- Acronym
- CARDIS
- Status last verified
- Sep 2026
- First submitted
- 14 Nov 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be made available to members of the research team after the principal investigator has completed blinded analyses of the primary and secondary outcomes. Data will be stored securely and access will be restricted to authorized collaborators under data use agreements.
Publications
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.
PubMed 41674709
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Web-based Support Programme for Cardiac Arrest Survivors: A Randomized Controlled Trial With Process Evaluation (The CARDIS Study)
- ClinicalTrials.gov ID
- NCT07240714
- Acronym / sponsor ID
- CARDIS / 2025-06113-01
- Conditions
- Cardiac Arrest (CA)
- Keywords
- Cardiac arrest, Digital support programme, Web-based intervention, Mental wellbeing, Quality of life, Fatigue, Cognitive function, Anxiety and depression
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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 six 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-Based Support Programme for Cardiac Arrest Survivors | Experimental | Behavioral: Digital Support Programme |
| Waitlist Control (Standard Care + Delayed Access) | No intervention | –Participants in this arm receive standard follow-up care according to national guidelines. They do not have access to the digital support programme during the study period. However, they are placed on a waitlist and are offered access to the programme after study completion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Support ProgrammeThe 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. | Behavioural | Web-Based Support Programme for Cardiac Arrest Survivors |
Primary outcome
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.
8 secondary outcomes
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 Life Satisfaction at 3 and 6 months.
Time frame: From baseline to 3 and 6 months after enrollment.
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 Depression at 3 and 6 months.
Time frame: From baseline to 3 and 6 months after enrollment.
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 Fatigue at 3 and 6 months.
Time frame: From baseline to 3 and 6 months after enrollment.
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 Cognitive Function at 3 and 6 months.
Time frame: From baseline to 3 months after enrollment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Derived from this study: PubMed 41674709Waldemar 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be made available to members of the research team after the principal investigator has completed blinded analyses of the primary and secondary outcomes. Data will be stored securely and access will be restricted to authorized collaborators under data use agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Support Programme in people with Cardiac Arrest (CA), run by Linkoeping University at 9 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Overall Wellbeing at 3 months. (time frame: From baseline to 3 months after enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07240714, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.