Effect and Process Evaluation of the SME Tool

NCT ID: NCT06330415

Last Updated: 2024-03-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 404 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2025-08-01

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.

Conditions

Sick-listed Employees

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention group

Unlimited access to the SME tool.

Group Type: EXPERIMENTAL

The SME tool

Intervention Type: OTHER

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.

Control group

Care as usual by the occupational health service.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

The 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role: collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: lead

Responsible Party

Frederieke Schaafsma

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frederieke Schaafsma, Prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC

Central Contacts

Donna Beerda, MSc

Role: CONTACT

d.c.e.beerda@amsterdamumc.nl

+31647422076

References

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.

Reference Type: DERIVED

PMID: 39152487 (View on PubMed)

Other Identifiers

25603

Identifier Type: -

Identifier Source: org_study_id