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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).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

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 groups in NCT06330415
Study groupRoleWhat they receive
Intervention groupExperimentalUnlimited access to the SME tool.
Receives: Other: The SME tool
Control groupNo interventionCare as usual by the occupational health service.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted26 Mar 2024
  2. Study start1 May 2024 (estimated)
  3. Primary completion1 May 2025 (estimated)
  4. Study completion1 Aug 2025 (estimated)

Resources

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)
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

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.

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