A Digital Support to Facilitate Sustainable Return to Work for Persons With Chronic Pain and Their Employers

Study Overview
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Brief Summary
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Chronic musculoskeletal pain (CMSP) severely affects the individual's quality of life, functioning and ability to work, and comes with significant societal costs for sick leave and loss of productivity. After completing an Interdisciplinary Pain Rehabilitation Program (IPRP), patients with CMSP experience a gap in the return to work (RTW) process when the responsibility for RTW is taken over by the employer. To fill this gap, we aim to evaluate the clinical effectiveness of a digital support (SWEPPE) for promoting a sustainable RTW for persons with CMSP and to facilitate the employers' supportive role and responsibilities in the process. Our hypothesis is that using SWEPPE will decrease the need for sick-leave. SWEPPE is a smartphone application where the individual can create an action plan, perform daily registrations of health aspects, self-monitoring of health aspects and goals, have access to a library with evidence-based facts and a coach, and the possibility to share information with the employer.The employer access SWEPPE via a web application. In this trial, we will recruit patients with CMSP aged 18-65 years who have completed IPRP, and who need support during RTW or continued support at the work placement for creating a sustainable work situation. The participants will be randomly assigned to either receive SWEPPE or to the control group. The intervention group will use SWEPPE during twelve months and the control group will not receive any active intervention for RTW which is standard clinical practice. Participants will be recruited from specialist and primary care level units connected to the Swedish National Quality Registry for Pain Rehabilitation (SQRP) and providing IPRP for patients with CMSP. All participants will fill in questionnaires when they have completed the rehabilitation program and before the intervention starts. Study ending assessment will be performed after twelve months. The clinical effectiveness of SWEPPE will be assessed by number of days with sickness cash benefit. Several dimensions of sick-leave will be assessed according to the Swedish Social Insurance Agency's (SSIA) proposal of outcome measures of RTW. Other outcomes and explanatory variables including important domains affected by CMSP such as health-related quality of life, functioning and work ability will be collected. A sample size calculation indicates the need for recruiting 360 participants (n=180 for each group).

Official Title
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An Evidence-based Digital Support for One Year to Facilitate a Sustainable Return to Work for Persons With Chronic Musculoskeletal Pain and Their Employers: Study Protocol for a Registry-based Multicentre Randomized Controlled Trial.

Conditions
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Chronic Pain

Intervention / Treatment
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* Device: SWEPPE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients entering the trial must have completed IPRP. The principal inclusion criteria for IPRP in Sweden are: persistent or intermittent pain lasting ≥3 months pain affecting daily activities to a large extent, completed systematic assessment and non-pharmacological optimization is completed, screening for psychosocial risk factors and differential diagnosis completed In addition the following criteria will be applied: Completed participation in an Interdisciplinary Pain Rehabilitation Program (IPRP) at any of the participating units. Having an employment to return to after IPRP or having returned to work but need continued support for creating a sustainable work situation after IPRP. Exclusion criteria: Completed IPRP but are unemployed or unable to return to work.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SWEPPE<br>Participants will receive the smartphone application SWEPPE. | Device: SWEPPE<br>* In the smartphone application SWEPPE the individual can create an action plan, perform daily registrations of health aspects, self-monitoring of health aspects and goals, have access to a library with evidence-based facts and a coach, and possibility to share information with the employer.<br>|
| No Intervention: Control<br>Participants randomized to the control group will not receive any active intervention for return to work after completing an Interdisciplinary Pain Rehabilitation Program . | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sick leave | Number of gross and net days with sickness cash benefit | 12 months follow up after IPRP | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return to work | Return to work (partially or full time) every month | 12 months follow up after IPRP | 
| Sick-leave spells per months | Number of sick-leave spells (per month) | 12 months follow up after IPRP | 
| Return to work group level | Proportions of a group who returns to full- or part-time work (per month) | 12 months follow up after IPRP | 
| Working days before new sick leave | Number of days in work before new sick leave during study period | 12 months follow up after IPRP | 
| Proportion back to work | Proportion of a group back to work >28 days (full- or part time) before a new sick-leave spell occurs | 12 months follow up after IPRP | 
| Total sick-leave spells | Number of sick-leave spells during study period | 12 months follow up after IPRP | 
| Length of total sick leave | Length of total sick leave during study period | 12 months follow up after IPRP | 
| Pain intensity last 7 days | Numeric rating scale | Baseline and 12 months | 
| Consequences of pain on daily life | Multidimensional Pain Inventory Swedish version | Baseline and 12 months | 
| Overall emotional distress | Hospital Anxiety and Depression Scale Swedish version | Baseline and 12 months | 
| Physical and mental health | RAND-36 Swedish version | Baseline and 12 months | 
| Goal fulfilment and satisfaction during the study period | Self-reported data | Baseline and 12 months | 
| Self-reported physical work environment | Questionnaire based on the Swedish Work Environment Authority ergonomics checklist | Baseline and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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collaboration support, eHealth, employer support, smartphone application, return to work, self-management