Rehabilitation for Survivors of Out-of-hospital Cardiac Arrest

The ROCK Trial. A Multidisciplinary Rehabilitation Intervention Targeted Return-to-work in Sudden Out-of-hospital Cardiac Arrest Survivors A Pragmatic Randomised Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Arrest; Rehabilitation; Cardiac Arrest; Cardiac Rehabilitation; Cardiopulmonary Resuscitation; Recovery of Function; Return to Work; Return-to-work
• Intervention / Treatment: Other: Usual care; Other: Individually tailored rehabilitation intervention

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.

• Study Type: Interventional
• Enrollment (Anticipated): 214
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jan Christensen, PhD; Phone Number: 35453001; Email: fysjan@gmail.com

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Recruiting
    • Rigshospitalet
    • Contact: Jan Christensen, Senior researcher

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Individually tailored rehabilitation intervention; Individually tailored rehabilitation intervention
Active Comparator: 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.	Other: Usual care; Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Labour market participation using data from the DREAM database	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.	12-months after hospital discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Return-to-work - Multi-state models of patients change in states from baseline to 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.	12-months after hospital discharge
PRO: Readiness for return-to-work (RRTW)	Readiness for return-to-work (RRTW) consisting of 22 items.	2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge
PRO: Degree of return-to-work	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).	2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge
PROM: EQ-5D-5L	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.	Baseline (Hospital discharge), 2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge
PROM: Multidimensional fatigue inventory (MFI-20)	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.	Baseline (Hospital discharge), 2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge
PROM: The Hospital Anxiety and Depression Scale (HADS)	The questionnaire comprises seven questions for anxiety and seven questions for depression	Baseline (Hospital discharge), 2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge
PROM: The Pittsburgh Sleep Quality Index (PSQI)	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	Baseline (Hospital discharge), 2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge
The Health Literacy Questionnaire (HLQ)	HLQ has nine scales that each measure an aspect of the multidimensional construct of health literacy.	2 weeks, 26 weeks and 52 weeks after hospital discharge
PROM: Disease specific health-related quality of life (HeartQoL)	The HeartQoL questionnaire comprises 14-items forming a physical, emotional subscales and a global score,	2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge
The Impact of Event Scale - Revised (IES-R)	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)	12 weeks, 26 weeks and 52 weeks after hospital discharge

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montreal Cogntive Assessment (MoCA)	The MoCA is a cognitive screening test designed to assist Health Professionals in the detection of mild cognitive impairment	Baseline (Hospital discharge)
Assessment of Motor and Process Skills (AMPS)	Measures the quality of a person's ADL task performance	Baseline (Hospital discharge)
Neurocognitive testing: Trail Making Test (TMT) Parts A and B	the ability to think, reason, and remember	1 month after hospital discharge
Neurocognitive testing: The Wechsler Adult Intelligence Scale	WAIS-IV	1 month after hospital discharge
Neurocognitive testing: The Repeatable Battery for the Assessment of Neuropsychological Status	RBANS	1 month after hospital discharge
Neurocognitive testing: Rey Complex Figure Test	is a neuropsychological assessment in which examinees are asked to reproduce a complicated line drawing	1 month after hospital discharge
Neurocognitive testing: The Symbol Digit Modalities Test (SDMT)	A screening instrument to assess neurological dysfunction	1 month after hospital discharge
Neurocognitive testing: The Five-Point Test	The Five-Point Test is a test for measuring figural fluency functions	1 month after hospital discharge
Neurocognitive testing: The Kohs Block test	a performance test designed to be an IQ test	1 month after hospital discharge
Neurocognitive testing: Animal fluency	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	1 month after hospital discharge
Neurocognitive testing: Fluency S-words	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	1 month after hospital discharge

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Copenhagen University Hospital, Denmark
• Investigators: Principal Investigator: Jan Christensen, PhD, Department of Occupational Therapy and Physiotherapy, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: November 27, 2021
• First Submitted That Met QC Criteria: December 29, 2021
• First Posted (Actual): December 30, 2021

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Rehabilitation; Cardiac arrest; Cardiac Rehabilitation; Heart Arrest; Cardiopulmonary Resuscitation; Return to work; Recovery of Function; Labour marked; Return-to-work; Back to Work
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: H-20049654

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: By contacting the corresponding author and upon reasonable request, de-identified data can be made available for individual participant data meta-analysis.
• IPD Sharing Time Frame: After publication of all studies explicit stated in the Statistical Analysis Plan (SAP)
• IPD Sharing Access Criteria: By contacting the corresponding author and upon reasonable request, de-identified data can be made available for individual participant data meta-analysis.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No