Clinical trial NCT05058547: A Digital Support to Facilitate Sustainable Return to Work for Persons With Chronic Pain and Their Employers
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Keywords: collaboration support
eHealth
employer support
smartphone application
return to work
self-management
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
Collaborators: name: Swedish Council for Working Life and Social Research
First posted: 2021-09-27
Enrollment: 360
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: TREATMENT

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Sick leave
timeFrame: 12 months follow up after IPRP
Secondary outcomes:
measure: Return to work
timeFrame: 12 months follow up after IPRP
measure: Sick-leave spells per months
timeFrame: 12 months follow up after IPRP
measure: Return to work group level
timeFrame: 12 months follow up after IPRP
measure: Working days before new sick leave
timeFrame: 12 months follow up after IPRP
measure: Proportion back to work
timeFrame: 12 months follow up after IPRP
measure: Total sick-leave spells
timeFrame: 12 months follow up after IPRP
measure: Length of total sick leave
timeFrame: 12 months follow up after IPRP
measure: Pain intensity last 7 days
timeFrame: Baseline and 12 months
measure: Consequences of pain on daily life
timeFrame: Baseline and 12 months
measure: Overall emotional distress
timeFrame: Baseline and 12 months
measure: Physical and mental health
timeFrame: Baseline and 12 months
measure: Goal fulfilment and satisfaction during the study period
timeFrame: Baseline and 12 months
measure: Self-reported physical work environment
timeFrame: Baseline and 12 months
Other outcomes:
measure: Self-reported fatigue the last 7 days
timeFrame: Baseline and 12 months
measure: Self-reported level of sleepiness
timeFrame: Baseline and 12 months
measure: Self-reported level of sleep disturbance
timeFrame: Baseline and 12 months
measure: Self-reported fear of movement
timeFrame: Baseline and 12 months
measure: Self-reported physical activity
timeFrame: Baseline and 12 months
measure: Pain catastrophizing
timeFrame: Baseline and 12 months
measure: Perceived work ability
timeFrame: Baseline and 12 months
measure: Self-reported demands, control, and support at the workplace
timeFrame: Baseline and 12 months
measure: Perceived life Satisfaction
timeFrame: Baseline and 12 months
measure: Self-reported work situation during the study period
timeFrame: Baseline and 12 months
measure: Self-reported workload an average day
timeFrame: Baseline and 12 months
Locations:
city: Danderyd
country: Sweden
facility: Danderyd hospital
city: Karlstad
country: Sweden
facility: Smärtcentrum
city: Linköping
country: Sweden
facility: County council of Ostergotland
city: Lund
country: Sweden
facility: Smärtcentrum
city: Stockholm
country: Sweden
facility: Spine Center
Study officials:
affiliation: Linkoeping University
name: Mathilda Björk, PhD
role: PRINCIPAL_INVESTIGATOR
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