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NCT Number: NCT05173740

Rehabilitation for Survivors of Out-of-hospital Cardiac Arrest

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.

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rigshospitalet

Copenhagen, Denmark

Location status: Recruiting

Location contact

Jan Christensen, Senior researcher

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All adult survivors with first time out-of-hospital cardiac arrest
  • Discharged from the Hospitals will be assessed eligible for inclusion

Exclusion criteria

  • 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

Treatment and study plan

Individually tailored rehabilitation intervention

Other

Individually tailored rehabilitation intervention

Usual Care

Other

Usual care

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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.

  2. PRO: Readiness for return-to-work (RRTW)

    Time frame: 2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge

    Readiness for return-to-work (RRTW) consisting of 22 items.

  3. PRO: Degree of return-to-work

    Time frame: 2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge

    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).

  4. PROM: EQ-5D-5L

    Time frame: Baseline (Hospital discharge), 2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge

    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.

  5. PROM: Multidimensional fatigue inventory (MFI-20)

    Time frame: Baseline (Hospital discharge), 2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge

    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.

  6. 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

    The questionnaire comprises seven questions for anxiety and seven questions for depression

  7. 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 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

  8. The Health Literacy Questionnaire (HLQ)

    Time frame: 2 weeks, 26 weeks and 52 weeks after hospital discharge

    HLQ has nine scales that each measure an aspect of the multidimensional construct of health literacy.

  9. PROM: Disease specific health-related quality of life (HeartQoL)

    Time frame: 2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge

    The HeartQoL questionnaire comprises 14-items forming a physical, emotional subscales and a global score,

  10. The Impact of Event Scale - Revised (IES-R)

    Time frame: 12 weeks, 26 weeks and 52 weeks after hospital discharge

    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)

Other outcomes

  1. Montreal Cogntive Assessment (MoCA)

    Time frame: Baseline (Hospital discharge)

    The MoCA is a cognitive screening test designed to assist Health Professionals in the detection of mild cognitive impairment

  2. Assessment of Motor and Process Skills (AMPS)

    Time frame: Baseline (Hospital discharge)

    Measures the quality of a person's ADL task performance

  3. Neurocognitive testing: Trail Making Test (TMT) Parts A and B

    Time frame: 1 month after hospital discharge

    the ability to think, reason, and remember

  4. Neurocognitive testing: The Wechsler Adult Intelligence Scale

    Time frame: 1 month after hospital discharge

    WAIS-IV

  5. Neurocognitive testing: The Repeatable Battery for the Assessment of Neuropsychological Status

    Time frame: 1 month after hospital discharge

    RBANS

  6. Neurocognitive testing: Rey Complex Figure Test

    Time frame: 1 month after hospital discharge

    is a neuropsychological assessment in which examinees are asked to reproduce a complicated line drawing

  7. Neurocognitive testing: The Symbol Digit Modalities Test (SDMT)

    Time frame: 1 month after hospital discharge

    A screening instrument to assess neurological dysfunction

  8. Neurocognitive testing: The Five-Point Test

    Time frame: 1 month after hospital discharge

    The Five-Point Test is a test for measuring figural fluency functions

  9. Neurocognitive testing: The Kohs Block test

    Time frame: 1 month after hospital discharge

    a performance test designed to be an IQ test

  10. Neurocognitive testing: Animal fluency

    Time frame: 1 month after hospital discharge

    Verbal fluency tests are a kind of psychological test in which participants have to produce as many words as possible from a category in a given time

  11. Neurocognitive testing: Fluency S-words

    Time frame: 1 month after hospital discharge

    Verbal fluency tests are a kind of psychological test in which participants have to produce as many words as possible from a category in a given time

Study contacts

Contact information is provided by the study sponsor or research team.

Jan Christensen, PhD

CONTACT

[email protected]

35453001

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Copenhagen University Hospital, Denmark

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Dec 30, 2021
Registry last updated
Dec 8, 2025

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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