Rehabilitation for Survivors of Out-of-hospital Cardiac Arrest

NCT05173740 | Recruiting Phase 4 DMC

• 1 other identifier: H-20049654
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Return-to-work - Multi-state models of patients change in states from baseline to 12-months after hospital discharge

  12-months 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: EQ-5D-5L

  Baseline (Hospital discharge), 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

Other Outcomes (11)

• Montreal Cogntive Assessment (MoCA)

  Baseline (Hospital discharge)

• Assessment of Motor and Process Skills (AMPS)

  Baseline (Hospital discharge)

• Neurocognitive testing: Trail Making Test (TMT) Parts A and B

  1 month after hospital discharge

Study Arms (2)

Individually tailored rehabilitation intervention + usual care

EXPERIMENTAL

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

Usual care

ACTIVE COMPARATOR

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

Interventions

Individually tailored rehabilitation intervention OTHER

Individually tailored rehabilitation intervention

Individually tailored rehabilitation intervention + usual care

Usual care OTHER

Usual care

Usual care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult survivors with first time out-of-hospital cardiac arrest

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Copenhagen University Hospital, Denmark: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

RECRUITING

Related Publications (1)

• Christensen J, Winkel BG, Kirkeskov L, Folke F, Winther-Jensen M, Eckhardt-Bentsen C, Kjaergaard J, Hassager C, Wagner MK. The ROCK trial-a multidisciplinary Rehabilitation intervention for sudden Out-of-hospital Cardiac arrest survivors focusing on return-to-worK: a pragmatic randomized controlled trial protocol. Trials. 2024 Feb 1;25(1):99. doi: 10.1186/s13063-024-07911-6.

  PMID: 38303019 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Jan Christensen, PhD

  Department of Occupational Therapy and Physiotherapy, Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Christensen, PhD

CONTACT

35453001; fysjan@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: November 27, 2021
• First Posted: December 30, 2021
• Study Start: February 1, 2022
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2028
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After publication of all studies explicit stated in the Statistical Analysis Plan (SAP)
• Access Criteria: By contacting the corresponding author and upon reasonable request, de-identified data can be made available for individual participant data meta-analysis.

Locations

DK (1)