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Reducing Pain-Related Sickness Absence Through Workplace Health Literacy: A Hybrid II Study

Prevention of Pain-Related Sickness Absence Through Organizational Workplace Health Literacy Intervention - A Hybrid II Study.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07707180
Enrollment
193
Registered
2026-07-16
Start date
2027-03-01
Completion date
2028-05-30
Last updated
2026-07-16

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

Conditions

Healthy, Musculoskeletal Disorders, Occupational Health, Occupational Health Literacy

Keywords

occupational workplace health literacy, pain related sickness absence, pain communication, structured dialogues

Brief summary

The primary aim of this study is investigate whether a workplace intervention targeting employees' and managers' understanding of pain and communication (called occupational health literacy) can reduce pain-related sick leave and help employees and managers to better understand and manage work-related health matters. The study also aims to learn how the program works, who it works best for (or not), and how it can be successfully used long-term in real workplaces, especially in production environments. The study will e.g. examine whether the program: * reduces the number of sick days caused by pain, * lowers how much pain employees feel, and * improves employees' and managers' understanding of health and how to improve it. Expectation: Employees who participate in the program will: * take fewer sick days because of pain, * experience less pain, and have better health knowledge and skills than employees who continue with normal workplace practices. The study will identify: * what makes the program difficult or easy to introduce at workplaces, * which strategies help it succeed, and * what factors make the program continue working over time. Goal: Help workplaces adopt and maintain the program successfully.

Detailed description

The goal of this hybrid II randomized stepped wedge trial is to investigate if an organizational workplace health literacy intervention reduces pain-related sickness absence and pain intensity, and improves occupational health literacy - and to understand how and for whom the intervention can be successfully implemented and sustained in real-world workplaces within production sites. 1. Effectiveness: To evaluate the effectiveness of the intervention on the primary outcome of pain-related sickness absence (days lost) and secondary outcomes of pain intensity and occupational health literacy. Hypothesis: Receiving the intervention will lead to fewer pain-related sickness absence days, lower pain intensity scores, and higher occupational health literacy compared to receiving usual care during the control condition/phase. 2. Implementation - Barriers, Strategies and Mechanisms: To identify implementation barriers and targeted implementation strategies and to specify the underlying mechanisms of action supporting effective implementation and sustainability. Objective: To enhance local adoption, implementation and sustainability of the intervention. 3. Implementation - Process: To provide an assessment of the implementation process, focusing on adoption, reach, fidelity, and sustainability across participating workplaces, and to identify contextual and processual factors that promote or hinder successful implementation. Objective: Produce actionable implementation guidance and an evidence-informed strategy for broader roll-out and long-term maintenance. A stepped-wedge design is a type of a crossover study in which clusters cross over from the control arm to the intervention arm at different randomized time points. The clusters will be formed based on working teams (consisting of approximately 15 workers), randomly assigned to a step (of implementation of the intervention) four months apart. During the control phase/step, the participants receive standard care. In the workplace context, this implies that the control group can address work environment and health and safety issues through discussions within their health and safety organization. In Denmark, for workplaces with 10-34 employees, collaboration on health and safety is mandated to be organized within a health and safety organization, comprising one or more supervisors and one or more elected health and safety representatives, with the employer or a representative of the employer serving as chairman. This health and safety organization is tasked with both day-to-day and overarching responsibilities related to health and safety. Furthermore, workplaces or teams within the control group retain the option to seek assistance from trained work environment professionals external to their workplace if they choose to do so. The intervention consists of 4 elements; 1. A training day for the local workplace champion. 2. Needs and resource assessment at the workplace 3. Digital education in pain, communication and solutions for employees and managers 4. Structured 1:1 dialogues between workers and their supervisor. Method This project builds and extends upon a successful pilot of an organizational workplace health literacy (OWHL) intervention. Guided by the revised Medical Research Council (MRC) framework, the project aims to further develop, refine, and evaluate the effectiveness and implementation of the intervention and its core components to support the creation of a scalable workplace intervention suitable for implementation in production sites. The project will address the pilot study's limitations by 1. randomizing to reduce bias, 2. focus on an initial workplace needs assessment integrating a newly developed self-assessment workplace tool 3. Integrating a cost-effective digital Educational Program, and 4. tailoring implementation strategies to the particular target group and context/setting to ensure optimal uptake. Addressing these limitations of the pilot study is essential to strengthen the validity of the findings and enhance the intervention's practical applicability. Study setting and population The study population encompasses the 280.000 workers employed within production in Denmark, whereof 42 % are 50 years old, or older. This large working group is characterized by high physical and psychosocial work demands, with known potential challenges within safety communication between management and employees working the machines. Additionally, production workers experience around 10 days of sickness absence per year, report that they are overworked, and have elevated levels of pain, with a weekly pain prevalence of 43%. Consequently, this group is predisposed to an elevated risk of long-term sickness absence, and, in the most severe circumstances, premature withdrawal from the labor market. Randomization and blinding To avoid contamination between workers, cluster randomization will performed, with each working team constituting a cluster. The randomization will be balanced on the size of the working teams. A blinded independent data manager will perform a computer-generated randomization. Blinding of participants is not possible, owing to the nature of the trial. Data collection will be performed using questionnares delivered through text messages, and data managers and research personnel collecting/handling data will be blinded to group allocation if deemed practically feasible.

Interventions

BEHAVIORALCognitive behavioural therapy-inspired digital education on pain and communication

The main content of the intervention consists of 4 elements: 1. An educational day session for the local workplace champion, with a main focus on the ability to faciliate a digital education for the employees and managers. 2. An initial needs and resource assessment at the workplace focused on pain and health literacy, with participants from all organizational layers; employee, managers, HR and the workplace champion. The assessment aims to empower workplaces to self-assess their needs, contributing to own autonomy and direction. The session is facilitated by the researcher. 3. 2\*2 hours and 1\*2 hour booster session of digital education for the employees and managers seperately, focusing on pain knowledge and communication, and finding solutions for work. 4. A period of 4 months with structured 10-minutes 1:1 dialogues between an employee and the manager every 3-5 weeks, using the tools and communication from the educational content.

OTHERLocal work environment guidelines

While waiting for cross over, the control group can use available resources within the local working environment initiatives at the workplace.

Sponsors

National Research Centre for the Working Environment, Denmark
Lead SponsorOTHER_GOV
University of Southern Denmark
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Intervention model description

This is a stepped wedge cluster-RCT.

Eligibility

Sex/Gender
ALL
Age
18 Years to 68 Years
Healthy volunteers
Yes

Inclusion criteria

s for the workplaces are: * each team needs a minimum of 15 employees * the work environment organization at the workplace wants to participate in the study. All employees and managers are invited to participate.

Exclusion criteria

* There are no

Design outcomes

Primary

MeasureTime frameDescription
Pain-related sickness absenceThe time frame will be from baseline to end of intervention at 16 weeks. Seeing that this is a stepped wedge RCT, baseline is before entering the control-period.The primary outcome measure for effectiveness in this Hybrid 2 study, is self-reported pain-related sickness absence. Pain-related sickness absence will be assessed at baseline and every second week based on a questionnaire distributed by text messages to employees. The question to answer is: "In the last 4 weeks, how many days have you called in sick from work due to muscle pain?"
Implementation appropriatenessIAM is evaluated at 16 weeks, and through "Maintenance" 4 months after intervention end. Adoption and Implementation is evaluated after intervention end at 16 weeks.The primary implementation outcome in this Hybrid 2 study is Appropriateness. Appropriateness is evaluated with the IAM- Intervention Appropriateness Measure. It consists of 4 items rated on a Likert scale (e.g., strongly disagree to strongly agree), with statements such as whether the intervention seems fitting, suitable, applicable, or a good match for the setting. The measure will be evaluated by the Workplace champions, employees and managers through telephone interviews after the interventions ends at 16 weeks. Appropriateness is also explored through elements of the RE-AIM (secondary outcomes) evaluation (Adoption, Implementation and Maintenance) at 16 weeks through interviews (see secondary outcomes).

Secondary

MeasureTime frameDescription
Pain intensityFrom baseline, before entering the stepped wedge control period, to the end of treatment at 16 weeksPain intensity of the participating employees will be self-assessed through a numeric range scale (NRS). The evaluation will be conducted through a questionnaire sent by a text message at baseline, once a month, and after the intervention has ended. The NRS consists of 0 to 10 scale, where 0 is equivalent to no pain, and 10 indicates the worst possible pain.

Contacts

CONTACTMia Nyvang Stilling, PhD student
mng@nfa.dk+4551795855
CONTACTSebastian Venge Skovlund, PhD
svs@nfa.dk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 17, 2026