Rehabilitation for Survivors of Out-of-hospital Cardiac Arrest
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Individually tailored rehabilitation intervention, Usual care.
- Who it may be relevant to
- Registry conditions: Cardiac Arrest, Heart Arrest, Cardiopulmonary Resuscitation, Return to Work. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Other Individually tailored rehabilitation intervention
Individually tailored rehabilitation intervention - Other Usual care
Usual care
Primary outcome measures
- Labour market participation using data from the DREAM database [Time frame: 12-months after hospital discharge]
Secondary outcome measures (10)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Rigshospitalet — Copenhagen
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. PMID 38303019
Identifiers
NCT: NCT05173740 · H-20049654