Cardiac ArrestPhase 4NCT05173740
Rehabilitation for Survivors of Out-of-hospital Cardiac Arrest
A Phase 4 study testing Individually tailored rehabilitation intervention in people with Cardiac Arrest and Heart Arrest, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
This study is a parallel group multicentre investigator-initiated clinical randomised controlled superiority trial that will include a total of 214 survivors of OHCA. Participants will to be randomized with a 1:1 allocation ratio to either a intervention consisting of a comprehensive initiated tailored rehabilitation… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cardiac Arrest, Heart Arrest, Cardiopulmonary Resuscitation
- What is being tested?
- Individually tailored rehabilitation intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2022to 31 Jul 2028
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult survivors with first time out-of-hospital cardiac arrest
- Discharged from the Hospitals will be assessed eligible for inclusion
Who cannot join
- Survivors who prior to the cardiac arrest were not part of the labour force with at least two years until they are qualified to receive retirement state pensions
- Patients that cannot understand and fulfil the study surveys (in Danish)
- Patients with short witnessed cardiac arrests with return of spontaneous circulation estimated less than 4 minutes and immediate awakening without ICU treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen
Jan Christensen, Senior researcher
About this study
Official title: The ROCK Trial. A Multidisciplinary Rehabilitation Intervention Targeted Return-to-work in Sudden Out-of-hospital Cardiac Arrest Survivors A Pragmatic Randomised Controlled Trial
This study is a parallel group multicentre investigator-initiated clinical randomised controlled superiority trial that will include a total of 214 survivors of OHCA.
Participants will to be randomized with a 1:1 allocation ratio to either a intervention consisting of a comprehensive initiated tailored rehabilitation intervention focusing on supporting RTW plus usual care compared to usual care alone.
Read the detailed description
The ROCK trial is a two-arm multicentre investigator-initiated clinical randomised controlled superiority trial evaluating the effectiveness of a comprehensive individually tailored rehabilitation intervention focusing on supporting labour marked participation of survivors of out-of-hospital cardiac arrest compared to usual care, with primary endpoint measured after 12 months follow-up.
The overall aim of the ROCK trial is to evaluate the effectiveness of a comprehensive individually tailored multidisciplinary rehabilitation intervention for survivors of OHCA on RTW compared to usual care. The investigators hypothesize that the intervention will result in a higher-level labour marked attachment one year after hospital discharge in addition to increased health-related quality of life.
A full statistical analysis plan describing all details have been developed. In short, data from the national register on social transfer payments (DREAM database) will form the basis for the primary outcome. The primary outcome is labour market participation, defined as the proportion of employment vs. on social transfer payment, and the primary end point will be collected 12 months after hospital discharge.
- Conditions
- Cardiac Arrest, Heart Arrest, Cardiopulmonary Resuscitation, Return to Work, Return-to-work, Rehabilitation
- Being tested
- Individually tailored rehabilitation intervention, Usual care
- Keywords
- Labour marked, Cardiac arrest, Heart Arrest, Cardiopulmonary Resuscitation, Return to work, Return-to-work, Back to Work, Rehabilitation, Recovery of Function, Cardiac Rehabilitation
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individually tailored rehabilitation interventionOther
Individually tailored rehabilitation intervention
Usual careOther
Usual care
| Study group | Role | What they receive |
|---|---|---|
| Individually tailored rehabilitation intervention + usual care | Experimental | A comprehensive neurocognitive assessment and a thorough individual assessment of rehabilitation needs will be conducted to inform the individually tailored intervention plan. Core intervention elements are: 1) comprehensive assessment of individual rehabilitation needs including neuropsychology tests in order to make a individually tailored intervention plan coordinated with the multidisciplinary rehabilitation team, 2) providing strategies to lessen impact for the individual cognitive impairment, 3) educating survivors and relatives about the impact of a cardiac arrest and consequences on daily life, 4) work preparation, including establishment of routines and opportunities to practice work skills and 5) collaboration with the local municipality's job centre and employers to plan, support and monitor graded RTW, 6) short term therapy by psychologist dealing with thoughts and behaviour in relation to cardiac arrest. Receives: Other: Individually tailored rehabilitation intervention |
| Usual care | Active comparator | All participants including those allocated to the usual care group will be seen by an occupational therapist if their MoCA screening score ≤26. Furthermore, if considered relevant by the discharging unit, survivors are referred for rehabilitation provided and delivered in the local municipality where the participant is resident. The content of the rehabilitation will typically be based on the content of the rehabilitation plan from the discharging hospital unit and an individual assessment of the survivors' expressed needs, within the local municipality where the participant is resident. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Labour market participation using data from the DREAM database
The primary outcome of the clinical trial is labour market participation, defined as a dichotomized outcome, employment vs. on social transfer payment 12 months after hospital discharge.
Measured: 12-months after hospital discharge
Secondary outcomes (10)
Return-to-work - Multi-state models of patients change in states from baseline to 12-months after hospital discharge
3 multi-state models (working full-time, Working part-time, sick leave and the absorbing stated retired). Patients are not very likely to die during follow-up; this state may be superfluous. In the model working hours and retirement to private pensions will need to be assessed using self-reported data.
Measured: 12-months after hospital discharge
PRO: Readiness for return-to-work (RRTW)
Readiness for return-to-work (RRTW) consisting of 22 items.
Measured: 2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge
PRO: Degree of return-to-work
Single items covering degree of RTW in hours weekly (compared to prior to the cardiac arrest), job describtion (changed Y/N) and job modification (changes Y/N).
Measured: 2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge
PROM: EQ-5D-5L
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Measured: Baseline (Hospital discharge), 2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge
PROM: Multidimensional fatigue inventory (MFI-20)
The MFI is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: general fatigue, physical fatigue, reduced activity, reduced motivation and mental fatigue.
Measured: Baseline (Hospital discharge), 2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge
PROM: The Hospital Anxiety and Depression Scale (HADS)
The questionnaire comprises seven questions for anxiety and seven questions for depression
Measured: Baseline (Hospital discharge), 2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge
PROM: The Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score
Measured: Baseline (Hospital discharge), 2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge
The Health Literacy Questionnaire (HLQ)
HLQ has nine scales that each measure an aspect of the multidimensional construct of health literacy.
Measured: 2 weeks, 26 weeks and 52 weeks after hospital discharge
PROM: Disease specific health-related quality of life (HeartQoL)
The HeartQoL questionnaire comprises 14-items forming a physical, emotional subscales and a global score,
Measured: 2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge
The Impact of Event Scale - Revised (IES-R)
The Impact of Event Scale - Revised (IES-R) measures syptoms related to post-traumatic stress disorder (PTSD) The IES-R has 22 questions, that comprises a total subjective stress scale and three subscales (Intrusion, Avoidance, Hyperarousal)
Measured: 12 weeks, 26 weeks and 52 weeks after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start1 Feb 2022
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 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 ArrestStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Denmark
- Responsible party
- Principal investigator, Jan Christensen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Jan Christensen, PhD, Principal investigator, Department of Occupational Therapy and Physiotherapy, Rigshospitalet, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173740
- Sponsor's protocol ID
- H-20049654
- Status last verified
- Dec 2025
- First submitted
- 27 Nov 2021
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: By contacting the corresponding author and upon reasonable request, de-identified data can be made available for individual participant data meta-analysis.
Publications
Christensen J, Winkel BG, Kirkeskov L, Folke F, Winther-Jensen M, Eckhardt-Bentsen C, Kjaergaard J, Hassager C, Wagner MK. The ROCK trial-a multidisciplinary Rehabilitation intervention for sudden Out-of-hospital Cardiac arrest survivors focusing on return-to-worK: a pragmatic randomized controlled trial protocol. Trials. 2024 Feb 1;25(1):99. doi: 10.1186/s13063-024-07911-6.
PubMed 38303019
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ROCK Trial. A Multidisciplinary Rehabilitation Intervention Targeted Return-to-work in Sudden Out-of-hospital Cardiac Arrest Survivors A Pragmatic Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05173740
- Acronym / sponsor ID
- H-20049654
- Conditions
- Cardiac Arrest, Heart Arrest, Cardiopulmonary Resuscitation, Return to Work, Return-to-work, Rehabilitation
- Keywords
- Labour marked, Cardiac arrest, Heart Arrest, Cardiopulmonary Resuscitation, Return to work, Return-to-work, Back to Work, Rehabilitation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Denmark
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 30 Dec 2021 (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.
This study is a parallel group multicentre investigator-initiated clinical randomised controlled superiority trial that will include a total of 214 survivors of OHCA.
Participants will to be randomized with a 1:1 allocation ratio to either a intervention consisting of a comprehensive initiated tailored rehabilitation intervention focusing on supporting RTW plus usual care compared to usual care alone.
Detailed description
The ROCK trial is a two-arm multicentre investigator-initiated clinical randomised controlled superiority trial evaluating the effectiveness of a comprehensive individually tailored rehabilitation intervention focusing on supporting labour marked participation of survivors of out-of-hospital cardiac arrest compared to usual care, with primary endpoint measured after 12 months follow-up.
The overall aim of the ROCK trial is to evaluate the effectiveness of a comprehensive individually tailored multidisciplinary rehabilitation intervention for survivors of OHCA on RTW compared to usual care. The investigators hypothesize that the intervention will result in a higher-level labour marked attachment one year after hospital discharge in addition to increased health-related quality of life.
A full statistical analysis plan describing all details have been developed. In short, data from the national register on social transfer payments (DREAM database) will form the basis for the primary outcome. The primary outcome is labour market participation, defined as the proportion of employment vs. on social transfer payment, and the primary end point will be collected 12 months after hospital discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individually tailored rehabilitation intervention + usual care | Experimental | Other: Individually tailored rehabilitation interventionA comprehensive neurocognitive assessment and a thorough individual assessment of rehabilitation needs will be conducted to inform the individually tailored intervention plan. Core intervention elements are: 1) comprehensive assessment of individual rehabilitation needs including neuropsychology tests in order to make a individually tailored intervention plan coordinated with the multidisciplinary rehabilitation team, 2) providing strategies to lessen impact for the individual cognitive impairment, 3) educating survivors and relatives about the impact of a cardiac arrest and consequences on daily life, 4) work preparation, including establishment of routines and opportunities to practice work skills and 5) collaboration with the local municipality's job centre and employers to plan, support and monitor graded RTW, 6) short term therapy by psychologist dealing with thoughts and behaviour in relation to cardiac arrest. |
| Usual care | Active comparator | Other: Usual careAll participants including those allocated to the usual care group will be seen by an occupational therapist if their MoCA screening score ≤26. Furthermore, if considered relevant by the discharging unit, survivors are referred for rehabilitation provided and delivered in the local municipality where the participant is resident. The content of the rehabilitation will typically be based on the content of the rehabilitation plan from the discharging hospital unit and an individual assessment of the survivors' expressed needs, within the local municipality where the participant is resident. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All adult survivors with first time out-of-hospital cardiac arrest
- Discharged from the Hospitals will be assessed eligible for inclusion
Key exclusion criteria (3 listed)
- Survivors who prior to the cardiac arrest were not part of the labour force with at least two years until they are qualified to receive retirement state pensions
- Patients that cannot understand and fulfil the study surveys (in Danish)
- Patients with short witnessed cardiac arrests with return of spontaneous circulation estimated less than 4 minutes and immediate awakening without ICU treatment
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 |
|---|---|---|
| Individually tailored rehabilitation interventionIndividually tailored rehabilitation intervention | Other | Individually tailored rehabilitation intervention + usual care |
| Usual careUsual care | Other | Usual care |
Primary outcome
Labour market participation using data from the DREAM database
Time frame: 12-months after hospital discharge
The primary outcome of the clinical trial is labour market participation, defined as a dichotomized outcome, employment vs. on social transfer payment 12 months after hospital discharge.
10 secondary outcomes
Return-to-work - Multi-state models of patients change in states from baseline to 12-months after hospital discharge
Time frame: 12-months after hospital discharge
PRO: Readiness for return-to-work (RRTW)
Time frame: 2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge
PRO: Degree of return-to-work
Time frame: 2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge
PROM: EQ-5D-5L
Time frame: Baseline (Hospital discharge), 2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge
PROM: Multidimensional fatigue inventory (MFI-20)
Time frame: Baseline (Hospital discharge), 2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge
PROM: The Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline (Hospital discharge), 2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge
PROM: The Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline (Hospital discharge), 2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge
The Health Literacy Questionnaire (HLQ)
Time frame: 2 weeks, 26 weeks and 52 weeks after hospital discharge
PROM: Disease specific health-related quality of life (HeartQoL)
Time frame: 2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge
The Impact of Event Scale - Revised (IES-R)
Time frame: 12 weeks, 26 weeks and 52 weeks after hospital discharge
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 8 Dec 2025.
- Derived from this study: PubMed 38303019Christensen J, Winkel BG, Kirkeskov L, Folke F, Winther-Jensen M, Eckhardt-Bentsen C, Kjaergaard J, Hassager C, Wagner MK. The ROCK trial-a multidisciplinary Rehabilitation intervention for sudden Out-of-hospital Cardiac arrest survivors focusing on return-to-worK: a pragmatic randomized controlled trial protocol. Trials. 2024 Feb 1;25(1):99. doi: 10.1186/s13063-024-07911-6.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. By contacting the corresponding author and upon reasonable request, de-identified data can be made available for individual participant data meta-analysis.
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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.
Jan Christensen, PhD principal investigator
Department of Occupational Therapy and Physiotherapy, Rigshospitalet, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Individually tailored rehabilitation intervention in people with Cardiac Arrest and Heart Arrest, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Jan Christensen, PhD (35453001, fysjan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Labour market participation using data from the DREAM database (time frame: 12-months after hospital discharge). 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 NCT05173740, 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 8 Dec 2025.