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

Who is this study for? Survivors of out-of-hospital cardiac arrest
What treatments are being studied? Individually tailored rehabilitation intervention
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

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

• Discharged from the Hospitals will be assessed eligible for inclusion

Locations
Other Locations
Denmark
Rigshospitalet
RECRUITING
Copenhagen
Contact Information
Primary
Jan Christensen, PhD
fysjan@gmail.com
35453001
Time Frame
Start Date: 2022-02-01
Estimated Completion Date: 2028-07-31
Participants
Target number of participants: 214
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Rigshospitalet, Denmark
Collaborators: Copenhagen University Hospital, Denmark

This content was sourced from clinicaltrials.gov