Clinical trial NCT05173740: Rehabilitation for Survivors of Out-of-hospital Cardiac Arrest
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Cardiac Arrest
Heart Arrest
Cardiopulmonary Resuscitation
Return to Work
Return-to-work
Rehabilitation
Recovery of Function
Cardiac Rehabilitation
Keywords: Labour marked
Cardiac arrest
Heart Arrest
Cardiopulmonary Resuscitation
Return to work
Return-to-work
Back to Work
Rehabilitation
Recovery of Function
Cardiac Rehabilitation
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Copenhagen University Hospital, Denmark
First posted: 2021-12-30
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Labour market participation using data from the DREAM database
timeFrame: 12-months after hospital discharge
Secondary outcomes:
measure: Return-to-work - Multi-state models of patients change in states from baseline to 12-months after hospital discharge
timeFrame: 12-months after hospital discharge
measure: PRO: Readiness for return-to-work (RRTW)
timeFrame: 2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge
measure: PRO: Degree of return-to-work
timeFrame: 2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge
measure: PROM: EQ-5D-5L
timeFrame: Baseline (Hospital discharge), 2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge
measure: PROM: Multidimensional fatigue inventory (MFI-20)
timeFrame: Baseline (Hospital discharge), 2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge
measure: PROM: The Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline (Hospital discharge), 2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge
measure: PROM: The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline (Hospital discharge), 2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge
measure: The Health Literacy Questionnaire (HLQ)
timeFrame: 2 weeks, 26 weeks and 52 weeks after hospital discharge
measure: PROM: Disease specific health-related quality of life (HeartQoL)
timeFrame: 2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge
measure: The Impact of Event Scale - Revised (IES-R)
timeFrame: 12 weeks, 26 weeks and 52 weeks after hospital discharge
Other outcomes:
measure: Montreal Cogntive Assessment (MoCA)
timeFrame: Baseline (Hospital discharge)
measure: Assessment of Motor and Process Skills (AMPS)
timeFrame: Baseline (Hospital discharge)
measure: Neurocognitive testing: Trail Making Test (TMT) Parts A and B
timeFrame: 1 month after hospital discharge
measure: Neurocognitive testing: The Wechsler Adult Intelligence Scale
timeFrame: 1 month after hospital discharge
measure: Neurocognitive testing: The Repeatable Battery for the Assessment of Neuropsychological Status
timeFrame: 1 month after hospital discharge
measure: Neurocognitive testing: Rey Complex Figure Test
timeFrame: 1 month after hospital discharge
measure: Neurocognitive testing: The Symbol Digit Modalities Test (SDMT)
timeFrame: 1 month after hospital discharge
measure: Neurocognitive testing: The Five-Point Test
timeFrame: 1 month after hospital discharge
measure: Neurocognitive testing: The Kohs Block test
timeFrame: 1 month after hospital discharge
measure: Neurocognitive testing: Animal fluency
timeFrame: 1 month after hospital discharge
measure: Neurocognitive testing: Fluency S-words
timeFrame: 1 month after hospital discharge
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Department of Occupational Therapy and Physiotherapy, Rigshospitalet, Denmark
name: Jan Christensen, PhD
role: PRINCIPAL_INVESTIGATOR
References: