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

Linköping University (LiU)

Status: Enrolling

Conditions: Chronic Pain

Treatments: Device: SWEPPE

Study type: Interventional

Funder types: Other

Identifiers

NCT05058547

Dnr 2019-01264

Details and patient eligibility

About

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).

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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360 participants in 2 patient groups

SWEPPE

Experimental group

Description:

Participants will receive the smartphone application SWEPPE.

Treatment:

Device: SWEPPE

Control

No Intervention group

Description:

Participants randomized to the control group will not receive any active intervention for return to work after completing an Interdisciplinary Pain Rehabilitation Program .