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 |
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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
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
Principal Investigator
Center for Hjernerystelse
Amagerfælledvej 56A
Copenhagen
2300
Denmark
0000-0002-2910-372X | |
Phone | +45 21651533 |
hana.mala@psy.ku.dk |
Public
Amagerfælledvej 56 A
København S
2300
Denmark
Phone | +45 51430312 |
---|---|
irene.conradsen@cfh.ku.dk |
Study information
Study design | Cross-sectional multicenter observational survey study |
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Primary study design | Observational |
Secondary study design | Cross sectional study |
Study setting(s) | Home |
Study type | Quality of life |
Participant information sheet | The participant information sheet (only in Danish) is available upon request to the study contact persons. |
Scientific title | Return 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 acronym | ARCOMS |
Study hypothesis | 1. 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 |
Condition | Concussion or minor traumatic brain injury |
Intervention | This 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 type | Other |
Primary outcome measure | Work-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 measures | Knowledge 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 date | 17/08/2021 |
Overall study end date | 01/02/2023 |
Eligibility
Participant type(s) | Mixed |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 100 persons with persistent post-concussion symptoms |
Total final enrolment | 92 |
Participant inclusion criteria | Employees: 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 criteria | Does not meet inclusion criteria |
Recruitment start date | 01/10/2021 |
Recruitment end date | 06/09/2022 |
Locations
Countries of recruitment
- Denmark
Study participating centres
Copenhagen
2300
Denmark
Copenhagen
2300
Denmark
Hellerup
2900
Denmark
Kolding
6000
Denmark
Vejle
7100
Denmark
Næstved
4700
Denmark
Herning
7400
Denmark
Slagelse
4200
Denmark
Kongens Lyngby
2800
Denmark
Odense
5000
Denmark
Sponsor information
University/education
Institut of Psychology
Øster Farimagsgade 2A
Copenhagen
1353
Denmark
Phone | +45 21651533 |
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christina.molin@samf.ku.dk | |
Website | https://psy.ku.dk/ |
https://ror.org/035b05819 |
Research organisation
Amagerfælledvej 56A
Copenhagen
2300
Denmark
Phone | +45 51430312 |
---|---|
irene.conradsen@cfh.ku.dk | |
Website | www.dfch.dk |
Funders
Funder type
Charity
No information available
Results and Publications
Intention to publish date | 01/12/2024 |
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Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Available on request |
Publication and dissemination plan | Planned publication in a high-impact peer-review journal |
IPD sharing plan | The 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
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.