The ROCK Trial. A Multidisciplinary Rehabilitation Intervention Targeted Return-to-work in Sudden Out-of-hospital Cardiac Arrest Survivors A Pragmatic Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- Labour market participation using data from the DREAM database
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult survivors with first time out-of-hospital cardiac arrest
- •Discharged from the Hospitals will be assessed eligible for inclusion
排除标准
- •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
研究组 & 干预措施
Individually tailored rehabilitation intervention + usual care
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.
干预措施: Individually tailored rehabilitation intervention (Other)
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.
干预措施: Usual care (Other)
结局指标
主要结局
Labour market participation using data from the DREAM database
时间窗: 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.
次要结局
- Return-to-work - Multi-state models of patients change in states from baseline to 12-months after hospital discharge(12-months after hospital discharge)
- PROM: EQ-5D-5L(Baseline (Hospital discharge), 2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge)
- The Health Literacy Questionnaire (HLQ)(2 weeks, 26 weeks and 52 weeks after hospital discharge)
- PROM: The Hospital Anxiety and Depression Scale (HADS)(Baseline (Hospital discharge), 2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge)
- PROM: The Pittsburgh Sleep Quality Index (PSQI)(Baseline (Hospital discharge), 2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge)
- PROM: Disease specific health-related quality of life (HeartQoL)(2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge)
- The Impact of Event Scale - Revised (IES-R)(12 weeks, 26 weeks and 52 weeks after hospital discharge)
- PRO: Readiness for return-to-work (RRTW)(2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge)
- PRO: Degree of return-to-work(2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge)
- PROM: Multidimensional fatigue inventory (MFI-20)(Baseline (Hospital discharge), 2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge)
研究者
Jan Christensen
Senior Researcher
Rigshospitalet, Denmark