A Digital Support to Facilitate Sustainable Return to Work for Persons With Chronic Pain and Their Employers
NCT ID: NCT05058547
Last Updated: 2022-03-25
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
360 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-03-01
Study Completion Date
2024-12-31
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).
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).
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Detailed Description
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Conditions
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Chronic Pain
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
Study Groups
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SWEPPE
Participants will receive the smartphone application SWEPPE.
Group Type
EXPERIMENTAL
SWEPPE
Intervention Type
DEVICE
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.
Control
Participants randomized to the control group will not receive any active intervention for return to work after completing an Interdisciplinary Pain Rehabilitation Program .
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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SWEPPE
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.
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Swedish Council for Working Life and Social Research
OTHER
Sponsor Role
collaborator
Linkoeping University
OTHER_GOV
Sponsor Role
lead
Responsible Party
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Mathilda Björk
Deputy Head of Department, Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Mathilda Björk, PhD
Role: PRINCIPAL_INVESTIGATOR
Linkoeping University
Locations
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Danderyd hospital
Danderyd, , Sweden
Site Status
RECRUITING
Smärtcentrum
Karlstad, , Sweden
Site Status
NOT_YET_RECRUITING
County council of Ostergotland
Linköping, , Sweden
Site Status
RECRUITING
Smärtcentrum
Lund, , Sweden
Site Status
NOT_YET_RECRUITING
Spine Center
Stockholm, , Sweden
Site Status
NOT_YET_RECRUITING
Countries
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Sweden
Central Contacts
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References
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Reference Type
DERIVED
Other Identifiers
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Dnr 2019-01264
Identifier Type: -
Identifier Source: org_study_id
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