Rehabilitation for Survivors of Out-of-hospital Cardiac Arrest
- Conditions
- Return-to-workReturn to WorkHeart ArrestRehabilitationRecovery of FunctionCardiac ArrestCardiopulmonary ResuscitationCardiac Rehabilitation
- Interventions
- Other: Individually tailored rehabilitation interventionOther: Usual care
- Registration Number
- NCT05173740
- Lead Sponsor
- Rigshospitalet, Denmark
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 214
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Individually tailored rehabilitation intervention + usual care Individually tailored rehabilitation intervention A comprehensive neurocognitive assessment and a thorough individual assessment of rehabilitation needs will be conducted to inform the individually tailored intervention plan. Core intervention elements are: 1) comprehensive assessment of individual rehabilitation needs including neuropsychology tests in order to make a individually tailored intervention plan coordinated with the multidisciplinary rehabilitation team, 2) providing strategies to lessen impact for the individual cognitive impairment, 3) educating survivors and relatives about the impact of a cardiac arrest and consequences on daily life, 4) work preparation, including establishment of routines and opportunities to practice work skills and 5) collaboration with the local municipality's job centre and employers to plan, support and monitor graded RTW, 6) short term therapy by psychologist dealing with thoughts and behaviour in relation to cardiac arrest. Usual care Usual care All participants including those allocated to the usual care group will be seen by an occupational therapist if their MoCA screening score ≤26. Furthermore, if considered relevant by the discharging unit, survivors are referred for rehabilitation provided and delivered in the local municipality where the participant is resident. The content of the rehabilitation will typically be based on the content of the rehabilitation plan from the discharging hospital unit and an individual assessment of the survivors' expressed needs, within the local municipality where the participant is resident.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.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: 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
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)
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: 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.
Trial Locations
- Locations (1)
Rigshospitalet
🇩🇰Copenhagen, Denmark