Rehabilitation for Survivors of Out-of-hospital Cardiac Arrest

Cardiac Arrest Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05173740
• Other study ID #: H-20049654
• Status: Recruiting
• Phase: Phase 4
• Start date: February 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2023
• Source: Rigshospitalet, Denmark
• Contact: Jan Christensen, PhD
• Phone: 35453001
• Email: fysjan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 214
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Cardiac Rehabilitation
• Cardiopulmonary Resuscitation
• Heart Arrest
• Out-of-Hospital Cardiac Arrest
• Recovery of Function
• Rehabilitation
• Return to Work

Intervention

Other:
• Individually tailored rehabilitation intervention
Individually tailored rehabilitation intervention
• Usual care
Usual care

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Copenhagen University Hospital, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	Assessment of Motor and Process Skills (AMPS)	Measures the quality of a person's ADL task performance	Baseline (Hospital discharge)
Other	Neurocognitive testing: Trail Making Test (TMT) Parts A and B	the ability to think, reason, and remember	1 month after hospital discharge
Other	Neurocognitive testing: The Wechsler Adult Intelligence Scale	WAIS-IV	1 month after hospital discharge
Other	Neurocognitive testing: The Repeatable Battery for the Assessment of Neuropsychological Status	RBANS	1 month after hospital discharge
Other	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
Other	Neurocognitive testing: The Symbol Digit Modalities Test (SDMT)	A screening instrument to assess neurological dysfunction	1 month after hospital discharge
Other	Neurocognitive testing: The Five-Point Test	The Five-Point Test is a test for measuring figural fluency functions	1 month after hospital discharge
Other	Neurocognitive testing: The Kohs Block test	a performance test designed to be an IQ test	1 month after hospital discharge
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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