What knowledge and initiatives are applied by Danish employers when supporting employees with persistent post-concussion symptoms in returning to work and maintaining attachment to labour market?

ISRCTN ISRCTN12846389
DOI https://doi.org/10.1186/ISRCTN12846389
Secondary identifying numbers 514-202-21-2000
Submission date
30/03/2022
Registration date
03/05/2022
Last edited
16/08/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English Summary

Background and study aims
Concussion is one of the most frequently used neurological diagnoses in the Danish healthcare system and constitute more than 90 % of all head traumas. It is estimated that approximately 25,000 patients yearly become diagnosed with concussion in Denmark but this is likely underestimated since some patients do not seek medical assistance after concussion.
Most patients experience spontaneous recovery within the first 2-3 weeks , but up to 40 % develop persistent post-concussion symptoms (PPCS) such as headache, dizziness, vision problems, sleep problems, fatigue, concentration and memory difficulties, emotional problems etc. lasting beyond the natural recovery period. While some recover during the first months, approximately 35 % will continue to have symptoms 3 to 6 months or more after the trauma, including post traumatic psychological reactions such as anxiety, stress and depression. The PPCS have a long lasting effect on labor market attachment and employees with PPCS may therefore need support to stay employed. A Danish study shows that 43 % of employees with PPCS loose their connection to the labour market 5 years after the trauma and that 19 % receive welfare payments indicating reduced working capability. Furthermore, 5 % end up leaving labor marked altogether by receiving health-related early retirement pension.
The aim of this study is therefore to gather knowledge on which work-associated initiatives are presently used by Danish employers in order to support return to work of employees with PPCS. Secondly, we aim to map the needs of the employers regarding their knowledge about PPCS in order to provide support for successful work reintegration and work maintanances in employees PPCS.
The results from the survey will inform the content of an information folder targeting employers regarding how to create the best circumstances for employees with PPCS during the return-to-work process.

Who can participate?
Employees aged 18 - 65 years with PPCS lasting more than 4 weeks, who have experienced return to work within the last 12 months. It is furthermore required that the participants have been gainfully employed under regular conditions at the moment of head trauma.

What does the study involve?
The study is a national survey design where the participants and their employer complete the survey from home. The participants complete one survey (at the start of the study), and the employer completes two surveys: one about the return of the employee to the workplace some months after the employee has been enrolled in the study (1st follow-up) and one about maintaining the affiliation with the workplace 4 to 5 months after first follow-up (2nd follow-up).

What are the possible benefits and risks of participating?
The participants will not experience a direct benefit from participating, but they will contribute to the improvement of conditions of future PPCS employees. There are no direct risks associated with study participation.

Where is the study run from?
University of Copenhagen (Denmark)

When is the study starting and how long is it expected to run for?
August 2021 to February 2023

Who is funding the study?
Velliv Foreningen (Denmark)

Who is the main contact?
Hana Mala Rytter, hana.mala@psy.ku.dk

Contact information

Miss Hana Rytter
Principal Investigator

Center for Hjernerystelse
Amagerfælledvej 56A
Copenhagen
2300
Denmark

ORCiD logoORCID ID 0000-0002-2910-372X
Phone +45 21651533
Email hana.mala@psy.ku.dk
Miss Irene Conradsen
Public

Amagerfælledvej 56 A
København S
2300
Denmark

Phone +45 51430312
Email irene.conradsen@cfh.ku.dk

Study information

Study designCross-sectional multicenter observational survey study
Primary study designObservational
Secondary study designCross sectional study
Study setting(s)Home
Study typeQuality of life
Participant information sheet The participant information sheet (only in Danish) is available upon request to the study contact persons.
Scientific titleReturn to work after concussion - A survey of employees with persistent post-concussion symptoms and their employers regarding the initiatives to support reintegration in the work environment
Study acronymARCOMS
Study hypothesis1. Employers feel they lack sufficient knowledge about persistent symptoms after concussion and are unsure about the initiatives that can support their employees with lasting post-concussion symptoms in returning to work.
2. The survey will show that in most cases only a few of the possible work related initiatives were applied
3. Smaller companies will offer less initiatives to their employees with persistent post-concussion symptoms compared with larger companies
4. Employees with higher education will be offered more work related initiatives to return to work after concussion
5. There is a moderate correlation between higher amount of work relates initiatives and attachment to the labor marked
Ethics approval(s)Approved 17/08/2021, The Institutional Ethical Review Board, University of Copenhagen, Department of Psychology (ØSTER FARIMAGSGADE 2A, 1353 KØBENHAVN K, Copenhagen, Denmark; +45 35 32 49 25; jan.nielsen@psy.ku.dk), ref: IP-IRB/17082021
ConditionConcussion or minor traumatic brain injury
InterventionThis will be a survey study of employees with persistent post-concussion symptoms and their employers. One survey will be conducted on the employees (at the start of the study) and two surveys will be conducted on their employers at approximately 5 months and 10 months after their employees were enrolled in the study.

The employee survey at baseline will collect information about symptom severity via The Rivermead Post-Concussion Symptom Questionnaire (RPQ), and data on work-related activities via the Work Productivity and Activity Impairment Questionnaire (WPAIQ)) and The Work Role Functioning Questionnaire v2.0 (WRFQ). The employee surveys will be used to inform the development of the employer surveys.

The first of the employer surveys will be about the return of the employee to the workplace ~5 months after the employee has been enrolled in the study (1st follow-up) and the second about maintaining the affiliation with the workplace 4 to 5 months after first follow-up (2nd follow-up). These surveys consist of several validated questionnaires and specific survey questions developed by the scientists and clinicians participating in the study.
Intervention typeOther
Primary outcome measureWork-related initiatives (i.e. amount and type) that are applied across a variety of work places (i.e. public vs. private, small vs. large companies) in Denmark measured using employer surveys at 5 and 10 months
Secondary outcome measuresKnowledge regarding the needs of the employers in order to support successful reintegration in the work place for employees with persistent post-concussion symptoms with the aim of ensuring long-term labor marked attachment measured using employer surveys at 5 and 10 months
Overall study start date17/08/2021
Overall study end date01/02/2023

Eligibility

Participant type(s)Mixed
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants100 persons with persistent post-concussion symptoms
Total final enrolment92
Participant inclusion criteriaEmployees:
1. Between 18 and 65 years old
2. Suffering from persistent post-concussion symptoms diagnosed by a physician
3. Danish speaking
4. Being employed under regular terms prior to concussion or fully available and job seeking prior to concussion
5. Having experience with returning to work after their concussion within the last 12 months

Employers:
6. Danish or English speaking
Participant exclusion criteriaDoes not meet inclusion criteria
Recruitment start date01/10/2021
Recruitment end date06/09/2022

Locations

Countries of recruitment

  • Denmark

Study participating centres

The Danish Concussion Center
Amagerfælledvej 56A
Copenhagen
2300
Denmark
Center for Hjerneskade
Amagerfælledvej 56A
Copenhagen
2300
Denmark
Kommunikationscentret Region Hovedstaden
Rygårds Alle 45
Hellerup
2900
Denmark
CSV Kolding
Skovvejen 1B
Kolding
6000
Denmark
CSV Vejle
Solsikkevej 6
Vejle
7100
Denmark
VISP Næstved
Birkebjerg Allé 3
Næstved
4700
Denmark
CfK Herning
Brahmsvej 8
Herning
7400
Denmark
CSU Slagelse
Rosenkildevej 88 B
Slagelse
4200
Denmark
Cervello AS
Høstvej 3
Kongens Lyngby
2800
Denmark
CKV Odense
Heden 11
Odense
5000
Denmark

Sponsor information

University of Copenhagen
University/education

Institut of Psychology
Øster Farimagsgade 2A
Copenhagen
1353
Denmark

Phone +45 21651533
Email christina.molin@samf.ku.dk
Website https://psy.ku.dk/
ROR logo "ROR" https://ror.org/035b05819
Danish Center for Concussion
Research organisation

Amagerfælledvej 56A
Copenhagen
2300
Denmark

Phone +45 51430312
Email irene.conradsen@cfh.ku.dk
Website www.dfch.dk

Funders

Funder type

Charity

Vellivforeningen (Live well foundation)

No information available

Results and Publications

Intention to publish date01/12/2024
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer-review journal
IPD sharing planThe data can be made available upon request to the main contact person (hana.mala@psy.ku.dk).

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol file 04/01/2023 No No

Additional files

ISRCTN12846389_PROTOCOL.pdf

Editorial Notes

16/08/2023: The following changes have been made and the plain English summary updated accordingly:
1. The overall study end date has been changed from 30/11/2022 to 01/02/2023.
2. The intention to publish date was changed from 20/08/2023 to 01/12/2024.
27/04/2023: The following changes were made to the trial record:
1. The intention to publish date was changed from 20/02/2023 to 20/08/2023.
2. The total final enrolment was changed from 160 to 92. (Employees: 92; Employers: 66 in the first follow-up; Employers: 52 in the second follow-up)
04/01/2023: Protocol uploaded (not peer reviewed).
13/09/2022: The recruitment end date was changed from 30/08/2022 to 06/09/2022. Total final enrolment added.
08/04/2022: Trial’s existence confirmed by Department of Psychology, University of Copenhagen.