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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
214
Individually tailored rehabilitation intervention
Usual care
Rigshospitalet
Copenhagen, Denmark
RECRUITINGLabour 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.
Time frame: 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.
Time frame: 12-months after hospital discharge
PRO: Readiness for return-to-work (RRTW)
Readiness for return-to-work (RRTW) consisting of 22 items.
Time frame: 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).
Time frame: 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.
Time frame: 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.
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)
The questionnaire comprises seven questions for anxiety and seven questions for depression
Time frame: 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
Time frame: 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.
Time frame: 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,
Time frame: 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)
Time frame: 12 weeks, 26 weeks and 52 weeks after hospital discharge
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.