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Effect and Process Evaluation of the SME Tool

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06330415
Enrollment
404
Registered
2024-03-26
Start date
2024-05-01
Completion date
2025-08-01
Last updated
2024-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sick-listed Employees

Brief 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. The primary aim is to evaluate its impact on employee satisfaction with return-to-work support.

Interventions

OTHERThe SME tool

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.

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development
CollaboratorOTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

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.

Exclusion criteria

• Not have a colleague who is already participating in the study.

Design outcomes

Primary

MeasureTime frameDescription
Satisfaction with the RTW support of employer assessed by the employeeBaseline (T0), 1 month (T1), 3 month (T2) and 6 month (T3) follow-upThe 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.

Secondary

MeasureTime frameDescription
Total number of sick-leave daysBaseline (T0), 1 month (T1), 3 month (T2) and 6 month (T3) follow-upThe 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: ../../….).
Social supportBaseline (T0), 1 month (T1), 3 month (T2) and 6 month (T3) follow-upSocial 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.
Work performanceBaseline (T0), 1 month (T1), 3 month (T2) and 6 month (T3) follow-upWork 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.
Quality of working LifeBaseline (T0), 1 month (T1), 3 month (T2) and 6 month (T3) follow-upQuality 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.
Self-efficacyBaseline (T0), 1 month (T1), 3 month (T2) and 6 month (T3) follow-upSelf-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.
Satisfaction with the resumption of work of the respective employeeBaseline (T0), 1 month (T1), 3 month (T2) and 6 month (T3) follow-upSatisfaction 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.

Other

MeasureTime frameDescription
Perceived usefulness of the SME tool3 month (T2) and 6 month (T3) follow-upFor the process evaluation, the perceived usefulness of the SME tool is measured with self-developed questions regarding the usefulness of the tool, enhancement of knowledge and skills, and likelihood of recommending the tool to colleagues. For example through the question: 'Would you recommend the tool to other employers when guiding an employee who has reported ill?'. Response categories are multiple choice and open ended options.
Components of the logic model of change1 month (T1), 3 month (T2) and 6 month (T3) follow-upFor the process evaluation, the logic model of change components consists of the constructs: autonomy, competence, relatedness and ability. These are measured in self-developed questions such as: 'I have the skills to support an employee on sick leave.', 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. Individual scores represent the overall score of individual component, with higher score reflecting higher autonomy, competence, relatedness and ability.
ExperiencesCross-sectional after 6 months follow-upFor the process evaluation, the interpretation of the results from the RCT and potential implementation strategies for the national implementation of the tool will be explored via one-time interviews with 5-10 employees, 5-10 employers, and 5-10 OPs, out of a purposive sample of RCT participants.
Use of the SME tool3 month (T2) and 6 month (T3) follow-upFor the process evaluation, the use of the SME tool is measured with questions regarding number of visits, duration of visits, tool availability and web analytics. For example with the question: 'How often have you visited the SME tool in the past three months?'. Response categories comprise multiple choice and open ended options.
Recruitment1 month (T1), 3 month (T2) and 6 month (T3) follow-upFor the process evaluation, recruitment is measured through reasons for non-participation and the usefulness of recruitment strategies. This is measured in CASTOR with an open ended question, filled in by recruited employees who wish to not participate prior to the trial. Also a logbook related to recruitment strategies is maintained by the researchers, containing details about what recruitment strategy is used during the trial and the corresponding outcome.

Contacts

Primary ContactDonna Beerda, MSc
d.c.e.beerda@amsterdamumc.nl+31647422076

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026