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

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ClinicalTrials.gov Identifier: NCT05058547
Recruitment Status : Not yet recruiting
First Posted : September 27, 2021
Last Update Posted : September 27, 2021
Sponsor:
Collaborator:
Swedish Council for Working Life and Social Research
Information provided by (Responsible Party):
Mathilda Björk, Linkoeping University

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 150 participants (n=75 for each group).


Condition or disease Intervention/treatment Phase
Chronic Pain Device: SWEPPE Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Estimated Study Start Date : January 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: SWEPPE
Participants will receive the smartphone application SWEPPE.
Device: 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.

No Intervention: Control
Participants randomized to the control group will not receive any active intervention for return to work after completing an Interdisciplinary Pain Rehabilitation Program .



Primary Outcome Measures :
  1. Sick leave [ Time Frame: 12 months follow up after IPRP ]
    Number of gross and net days with sickness cash benefit


Secondary Outcome Measures :
  1. Return to work [ Time Frame: 12 months follow up after IPRP ]
    Return to work (partially or full time) every month

  2. Sick-leave spells per months [ Time Frame: 12 months follow up after IPRP ]
    Number of sick-leave spells (per month)

  3. Return to work group level [ Time Frame: 12 months follow up after IPRP ]
    Proportions of a group who returns to full- or part-time work (per month)

  4. Working days before new sick leave [ Time Frame: 12 months follow up after IPRP ]
    Number of days in work before new sick leave during study period

  5. Proportion back to work [ Time Frame: 12 months follow up after IPRP ]
    Proportion of a group back to work >28 days (full- or part time) before a new sick-leave spell occurs

  6. Total sick-leave spells [ Time Frame: 12 months follow up after IPRP ]
    Number of sick-leave spells during study period

  7. Length of total sick leave [ Time Frame: 12 months follow up after IPRP ]
    Length of total sick leave during study period

  8. Pain intensity last 7 days [ Time Frame: Baseline and 12 months ]
    Numeric rating scale

  9. Consequences of pain on daily life [ Time Frame: Baseline and 12 months ]
    Multidimensional Pain Inventory Swedish version

  10. Anxiety and depression [ Time Frame: Baseline and 12 months ]
    Hospital Anxiety and Depression Scale Swedish version

  11. Self-reported physical and psychological functioning and activity [ Time Frame: Baseline and 12 months ]
    EuroQol-5Dimensions and a 0-100 index Swedish version

  12. Physical and mental health [ Time Frame: Baseline and 12 months ]
    RAND-36 Swedish version

  13. Goal fulfilment and satisfaction during the study period [ Time Frame: During the follow-up period of 12 months ]
    Self-reported data in SWEPPE


Other Outcome Measures:
  1. Self-reported fatigue the last 7 days [ Time Frame: Baseline and 12 months ]
    Numeric rating scale

  2. Self-reported level of sleepiness [ Time Frame: Baseline and 12 months ]
    Karolinska Sleepiness Scale Swedish version

  3. Self-reported level of sleep disturbance [ Time Frame: Baseline and 12 months ]
    Insomnia Severity Index Swedish version

  4. Self-reported fear of movement [ Time Frame: Baseline and 12 months ]
    Tampa Scale for Kinesiophobia Swedish version

  5. Self-reported physical activity [ Time Frame: Baseline and 12 months ]
    the National Board of Health and Welfare's three questions on physical activity, exercise, and sedentary behavior.

  6. Pain catastrophizing [ Time Frame: Baseline and 12 months ]
    Pain Catastrophizing scale Swedish version

  7. Perceived work ability [ Time Frame: Baseline and 12 months ]
    Work Ability Index Swedish version

  8. Self-reported demands, control, and support at the workplace [ Time Frame: Baseline and 12 months ]
    Demand Control Support Questionnaire Swedish version

  9. Perceived life Satisfaction [ Time Frame: Baseline and 12 months ]
    Life satisfaction Scale Swedish version

  10. Self-reported work situation during the study period [ Time Frame: Baseline and 12 months ]
    Barriers for return to work, strategies to handle barriers and need of support from the employer

  11. Self-reported workload an average day [ Time Frame: Baseline and 12 months ]
    Number of hours per day for paid work and unpaid household work



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05058547


Contacts
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Contact: Mathilda Björk, PhD +4611363531 mathilda.bjork@liu.se

Locations
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Sweden
Danderyd hospital
Danderyd, Sweden, 182 57
Region Dalarna
Falun, Sweden, 791 29
County council of Ostergotland
Linköping, Sweden, 581 83
Sponsors and Collaborators
Linkoeping University
Swedish Council for Working Life and Social Research
Publications:
Magalhães L, Chan C, Chapman A, Majed L, Samigullina R, Trninic D, et al. Successful return to work of individuals with chronic pain according to health care providers: a meta-synthesis. Cadernos Brasileiros de Terapia Ocupacional/Brazilian Journal of Occupational Therapy 2017;25(4):825-37
Ruckenstein M. Visualized and interacted life: personal analytics and engagement with data doubles. Societies. 2014;4:68-84. doi: 10.3390/soc4010068.

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Responsible Party: Mathilda Björk, Deputy Head of Department, Professor, Linkoeping University
ClinicalTrials.gov Identifier: NCT05058547    
Other Study ID Numbers: Dnr 2019-01264
First Posted: September 27, 2021    Key Record Dates
Last Update Posted: September 27, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mathilda Björk, Linkoeping University:
collaboration support
eHealth
employer support
smartphone application
return to work
self-management
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations