Clinical trial NCT06330415: Effect and Process Evaluation of the SME Tool
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sick-listed Employees
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2024-03-26
Enrollment: 404
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Satisfaction with the RTW support of employer assessed by the employee
timeFrame: Baseline (T0), 1 month (T1), 3 month (T2) and 6 month (T3) follow-up
Secondary outcomes:
measure: Social support
timeFrame: Baseline (T0), 1 month (T1), 3 month (T2) and 6 month (T3) follow-up
measure: Total number of sick-leave days
timeFrame: Baseline (T0), 1 month (T1), 3 month (T2) and 6 month (T3) follow-up
measure: Work performance
timeFrame: Baseline (T0), 1 month (T1), 3 month (T2) and 6 month (T3) follow-up
measure: Quality of working Life
timeFrame: Baseline (T0), 1 month (T1), 3 month (T2) and 6 month (T3) follow-up
measure: Self-efficacy
timeFrame: Baseline (T0), 1 month (T1), 3 month (T2) and 6 month (T3) follow-up
measure: Satisfaction with the resumption of work of the respective employee
timeFrame: Baseline (T0), 1 month (T1), 3 month (T2) and 6 month (T3) follow-up
Other outcomes:
measure: Recruitment
timeFrame: 1 month (T1), 3 month (T2) and 6 month (T3) follow-up
measure: Use of the SME tool
timeFrame: 3 month (T2) and 6 month (T3) follow-up
measure: Perceived usefulness of the SME tool
timeFrame: 3 month (T2) and 6 month (T3) follow-up
measure: Components of the logic model of change
timeFrame: 1 month (T1), 3 month (T2) and 6 month (T3) follow-up
measure: Experiences
timeFrame: Cross-sectional after 6 months follow-up
Locations:
Study officials:
affiliation: Amsterdam UMC
name: Frederieke Schaafsma, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References: