Cardiac Arrest, Cardiac Rehabilitation, Cardiopulmonary Resuscitation, Heart Arrest, Recovery of Function, Rehabilitation, Return-to-work, Return to Work
Conditions
Keywords
Labour marked, Cardiac arrest, Heart Arrest, Cardiopulmonary Resuscitation, Return to work, Return-to-work, Back to Work, Rehabilitation, Recovery of Function, Cardiac Rehabilitation
Brief 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 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
OTHERIndividually tailored rehabilitation intervention
Individually tailored rehabilitation intervention
OTHERUsual care
Usual care
Sponsors
Copenhagen University Hospital, Denmark
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Before data extraction and data analysis all data will be anonymized, and group allocation will be blinded as (group X and Y). Participants will be randomly assigned to either the intervention or the usual care group using a computer random generator, with a 1:1 allocation. The randomisation will be conducted by a blinded investigator.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Labour market participation using data from the DREAM database | 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
| Measure | Time frame | Description |
|---|---|---|
| Return-to-work - Multi-state models of patients change in states from baseline to 12-months after hospital discharge | 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) | 2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge | Readiness for return-to-work (RRTW) consisting of 22 items. |
| PRO: Degree of return-to-work | 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). |
| PROM: EQ-5D-5L | 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. |
| PROM: Multidimensional fatigue inventory (MFI-20) | 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. |
| PROM: The Hospital Anxiety and Depression Scale (HADS) | 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 |
| PROM: The Pittsburgh Sleep Quality Index (PSQI) | 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 |
| The Health Literacy Questionnaire (HLQ) | 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. |
| PROM: Disease specific health-related quality of life (HeartQoL) | 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, |
| The Impact of Event Scale - Revised (IES-R) | 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
| Measure | Time frame | Description |
|---|---|---|
| Montreal Cogntive Assessment (MoCA) | Baseline (Hospital discharge) | 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) | Baseline (Hospital discharge) | Measures the quality of a person's ADL task performance |
| Neurocognitive testing: Trail Making Test (TMT) Parts A and B | 1 month after hospital discharge | the ability to think, reason, and remember |
| Neurocognitive testing: The Wechsler Adult Intelligence Scale | 1 month after hospital discharge | WAIS-IV |
| Neurocognitive testing: The Repeatable Battery for the Assessment of Neuropsychological Status | 1 month after hospital discharge | RBANS |
| Neurocognitive testing: Rey Complex Figure Test | 1 month after hospital discharge | is a neuropsychological assessment in which examinees are asked to reproduce a complicated line drawing |
| Neurocognitive testing: The Symbol Digit Modalities Test (SDMT) | 1 month after hospital discharge | A screening instrument to assess neurological dysfunction |
| Neurocognitive testing: The Five-Point Test | 1 month after hospital discharge | The Five-Point Test is a test for measuring figural fluency functions |
| Neurocognitive testing: The Kohs Block test | 1 month after hospital discharge | a performance test designed to be an IQ test |
| Neurocognitive testing: Animal fluency | 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 |
| Neurocognitive testing: Fluency S-words | 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 |
Countries
Denmark
Contacts
Primary ContactJan Christensen, PhD
Outcome results
None listed