Sick-listed EmployeesNCT06330415
Effect and Process Evaluation of the SME Tool
A study testing The SME tool in people with Sick-listed Employees, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Trial summary
A web-based tool has been developed to help small and medium-sized businesses support employees returning to work after sick-leave. A six-month trial is conducted, randomly assigning employer-employee dyads to either use the tool or receive standard care. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sick-listed Employees
- What is being tested?
- The SME tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 404 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Employees at study enrolment should:
- be of working age (18-65 years);
- have a fixed or temporary employment contract at a SME (≤ 250 employees), with a minimum of 6 months remaining in their contract;
- be currently sick-listed or partially sick-listed (≤8 weeks), with a risk of long-term absenteeism, based on the likelihood of the duration of sickness absence exceeding two months as assessed by their occupational physician;
- be able to understand and read Dutch sufficiently, in order to complete the questionnaires.
- The employer of the participating employee will be included. At time of study entry, the employer should be:
- an employer, supervisor, (case)manager or HR manager of a SME (≤ 250 employees). In this study, the employer is appointed by the employee and refers to the person who is the direct supervisor, in direct contact with the employee, and thus the person who offers the RTW support to the employee;
- able to understand and read Dutch sufficiently, in order to use the intervention and complete the questionnaires.
Who cannot join
- Not have a colleague who is already participating in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Web-based Intervention Supporting Employers of Small and Medium-sized Enterprises During the Return to Work of Employees on Long-term Sick-leave: Design of a Randomised Controlled Trial
A web-based tool has been developed to help small and medium-sized businesses support employees returning to work after sick-leave. A six-month trial is conducted, randomly assigning employer-employee dyads to either use the tool or receive standard care. The primary aim is to evaluate its impact on employee satisfaction with return-to-work support.
- Conditions
- Sick-listed Employees
- Being tested
- The SME tool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The SME toolOther
The intervention comprises of an open-access website targeting the employer of the sick-listed employee. The website provides practical resources, including templates, communication videos and information on legislation, workplace accommodations and most common reasons of sickness absence.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Unlimited access to the SME tool. Receives: Other: The SME tool |
| Control group | No intervention | Care as usual by the occupational health service. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction with the RTW support of employer assessed by the employee
The primary outcome is the employee satisfaction regarding the return-to-work support provided by the employer. This is measured using a single-item rating in a questionnaire: 'How satisfied are you with the sick-leave and return to work guidance you have received from your employer since the sick-leave/over the past month/3 months?', graded on a 5-point Likert scale ranging from very dissatisfied to very satisfied. The numerical scores assigned reflect the level of satisfaction, with higher scores indicative of higher satisfaction.
Measured: Baseline (T0), 1 month (T1), 3 month (T2) and 6 month (T3) follow-up
Secondary outcomes (6)
Social support
Social support is assessed through the four aspects of support, i.e.: 1) emotional support, 2) practical support, 3) informational support, and 4) appreciative support. The assessment entails eight questions in a questionnaire that inquire the importance and amount of support received, for example: 'How important is it that your employer provides emotional support during sick-leave and RTW? Explanation: Emotional support refers to the degree, we to which the employer shows understanding and listens to your concerns.' Response categories are: 1) very unimportant, 2) unimportant, 3) neutral, 4) important, and 5) very important. The mean score of the total sum is calculated, with higher scores indicating higher social support from the employer, collectively evaluating the overall level of social support provided by the employer.
Measured: Baseline (T0), 1 month (T1), 3 month (T2) and 6 month (T3) follow-up
Total number of sick-leave days
The total number of sick-leave days involves the assessment of the average number of working hours per week over the preceding four weeks and the total number of (partial) sick days, measured in a questionnaire. Answer categories include yes or no options and open-ended responses to express current employment status, for example date input (e.g., return to work since: ../../….).
Measured: Baseline (T0), 1 month (T1), 3 month (T2) and 6 month (T3) follow-up
Work performance
Work performance is evaluated using scale 2A from the Maastricht Instrument for Sustainable Employability (MAISE), reflecting the long-term capacity of employees to actively engage in and contribute to the workforce. The scale consists of six statements in a questionnaire, to be completed only if work tasks have been done in the past four weeks. For example: 'I have the knowledge to perform my job well.', are measured on a 5-point Likert scale. Response categories are: 1) completely disagree, 2) disagree, 3) neutral, 4) agree, and 5) completely agree. The mean score is calculated, with higher scores indicating higher work performance.
Measured: Baseline (T0), 1 month (T1), 3 month (T2) and 6 month (T3) follow-up
Quality of working Life
Quality of Working Life is measured using the Quality of Working Life Questionnaire for cancer survivors (QWLQ-CS). Subscale 2 about understanding and recognition in the organization, consisting of 5 items, is included in the questionnaire. For example: 'My supervisor understands my health situation and possible complaints.', measured on a 6-point Likert scale. Response categories comprise: 1) completely disagree, 2) disagree, 3) somewhat disagree, 4) somewhat agree, 5) agree, and 6) completely agree. The sum represents the overall score, with a higher score corresponding to a higher quality of working life.
Measured: Baseline (T0), 1 month (T1), 3 month (T2) and 6 month (T3) follow-up
Self-efficacy
Self-efficacy pertains to the perceived capability of the employer to effectively support employees during sickness absence. This evaluation is conducted with three items concerning meaningfulness, impact and skills, of the competence scale of the Empowerment Questionnaire. For example, statements such as: 'Supporting an employee who has reported sick is a significant responsibility for me.', are measured in a questionnaire on a 6-point Likert scale. Response categories are: 1) completely disagree, 2) disagree, 3) somewhat disagree, 4) somewhat agree, 5) agree, and 6) completely agree. The mean score of the sum is calculated, with higher scores reflect higher self-efficacy.
Measured: Baseline (T0), 1 month (T1), 3 month (T2) and 6 month (T3) follow-up
Satisfaction with the resumption of work of the respective employee
Satisfaction with the resumption of work of the respective employee: This is measured with one self-developed question in a questionnaire: 'How satisfied are you with the work resumption process of your employee in the past month/3 months?', on a 5-point Likert scale. Response categories are: 1) very dissatisfied, 2) dissatisfied, 3) neutral, 4) satisfied, and 5) very satisfied. The category represents the overall score, with a higher score reflecting higher satisfaction.
Measured: Baseline (T0), 1 month (T1), 3 month (T2) and 6 month (T3) follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start1 May 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sick-listed EmployeesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 404 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, Frederieke Schaafsma, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Frederieke Schaafsma, Prof. dr., Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330415
- Sponsor's protocol ID
- 25603
- Status last verified
- Mar 2024
- First submitted
- 14 Feb 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beerda DCE, Greidanus MA, de Rijk AE, de Wind A, Tamminga SJ, Schaafsma FG. The SME tool supporting employers of small- and medium-sized enterprises during the return to work of employees on long-term sick leave: study protocol for a randomized controlled trial and for a process evaluation. Trials. 2024 Aug 16;25(1):541. doi: 10.1186/s13063-024-08383-4.
PubMed 39152487
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-based Intervention Supporting Employers of Small and Medium-sized Enterprises During the Return to Work of Employees on Long-term Sick-leave: Design of a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06330415
- Acronym / sponsor ID
- 25603
- Conditions
- Sick-listed Employees
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 404 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A web-based tool has been developed to help small and medium-sized businesses support employees returning to work after sick-leave. A six-month trial is conducted, randomly assigning employer-employee dyads to either use the tool or receive standard care. The primary aim is to evaluate its impact on employee satisfaction with return-to-work support.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: The SME toolUnlimited access to the SME tool. |
| Control group | No intervention | –Care as usual by the occupational health service. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- be of working age (18-65 years);
- have a fixed or temporary employment contract at a SME (≤ 250 employees), with a minimum of 6 months remaining in their contract;
- be currently sick-listed or partially sick-listed (≤8 weeks), with a risk of long-term absenteeism, based on the likelihood of the duration of sickness absence exceeding two months as assessed by their occupational physician;
- be able to understand and read Dutch sufficiently, in order to complete the questionnaires.
- The employer of the participating employee will be included. At time of study entry, the employer should be:
Key exclusion criteria (1 listed)
- Not have a colleague who is already participating in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The SME toolThe intervention comprises of an open-access website targeting the employer of the sick-listed employee. The website provides practical resources, including templates, communication videos and information on legislation, workplace accommodations and most common reasons of sickness absence. | Other | Intervention group |
Primary outcome
Satisfaction with the RTW support of employer assessed by the employee
Time frame: Baseline (T0), 1 month (T1), 3 month (T2) and 6 month (T3) follow-up
The primary outcome is the employee satisfaction regarding the return-to-work support provided by the employer. This is measured using a single-item rating in a questionnaire: 'How satisfied are you with the sick-leave and return to work guidance you have received from your employer since the sick-leave/over the past month/3 months?', graded on a 5-point Likert scale ranging from very dissatisfied to very satisfied. The numerical scores assigned reflect the level of satisfaction, with higher scores indicative of higher satisfaction.
6 secondary outcomes
Social support
Time frame: Baseline (T0), 1 month (T1), 3 month (T2) and 6 month (T3) follow-up
Total number of sick-leave days
Time frame: Baseline (T0), 1 month (T1), 3 month (T2) and 6 month (T3) follow-up
Work performance
Time frame: Baseline (T0), 1 month (T1), 3 month (T2) and 6 month (T3) follow-up
Quality of working Life
Time frame: Baseline (T0), 1 month (T1), 3 month (T2) and 6 month (T3) follow-up
Self-efficacy
Time frame: Baseline (T0), 1 month (T1), 3 month (T2) and 6 month (T3) follow-up
Satisfaction with the resumption of work of the respective employee
Time frame: Baseline (T0), 1 month (T1), 3 month (T2) and 6 month (T3) follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Derived from this study: PubMed 39152487Beerda DCE, Greidanus MA, de Rijk AE, de Wind A, Tamminga SJ, Schaafsma FG. The SME tool supporting employers of small- and medium-sized enterprises during the return to work of employees on long-term sick leave: study protocol for a randomized controlled trial and for a process evaluation. Trials. 2024 Aug 16;25(1):541. doi: 10.1186/s13063-024-08383-4.
- Individual participant dataSharing planned: No
Related trials for Sick-listed Employees
RecruitingObservational study
Back on Track: Evaluation of an Occupational Reintegration Protocol for Employees With Musculoskeletal Disorders
Musculoskeletal Disorders (MSDs)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederieke Schaafsma, Prof. dr. principal investigator
Amsterdam UMC
Questions about this trial
What is this clinical trial studying?
A study testing The SME tool in people with Sick-listed Employees, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Donna Beerda, MSc (+31647422076, d.c.e.beerda@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction with the RTW support of employer assessed by the employee (time frame: Baseline (T0), 1 month (T1), 3 month (T2) and 6 month (T3) follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06330415, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.