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.
All adult survivors with first time out-of-hospital cardiac arrest
Discharged from the Hospitals will be assessed eligible for inclusion
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
Parallel
Individually tailored rehabilitation intervention
Other interventionIndividually tailored rehabilitation intervention
Usual care
Other interventionUsual care
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.
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.
PRO: Readiness for return-to-work (RRTW)
Readiness for return-to-work (RRTW) consisting of 22 items.
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).
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.
Montreal Cogntive Assessment (MoCA)
The MoCA is a cognitive screening test designed to assist Health Professionals in the detection of mild cognitive impairment
Assessment of Motor and Process Skills (AMPS)
Measures the quality of a person's ADL task performance
Neurocognitive testing: Trail Making Test (TMT) Parts A and B
the ability to think, reason, and remember
Neurocognitive testing: The Wechsler Adult Intelligence Scale
WAIS-IV
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Rigshospitalet, Denmark
Lead sponsor
Copenhagen University Hospital, Denmark
Collaborator
