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

Sponsor
Linkoeping University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05058547
Collaborator
Swedish Council for Working Life and Social Research (Other)
360
Enrollment
5
Locations
2
Arms
33.1
Anticipated Duration (Months)
72
Patients Per Site
2.2
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: SWEPPE
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
360 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
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.
Actual Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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 .

Outcome Measures

Primary Outcome Measures

  1. Sick leave [12 months follow up after IPRP]

    Number of gross and net days with sickness cash benefit

Secondary Outcome Measures

  1. Return to work [12 months follow up after IPRP]

    Return to work (partially or full time) every month

  2. Sick-leave spells per months [12 months follow up after IPRP]

    Number of sick-leave spells (per month)

  3. Return to work group level [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 [12 months follow up after IPRP]

    Number of days in work before new sick leave during study period

  5. Proportion back to work [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 [12 months follow up after IPRP]

    Number of sick-leave spells during study period

  7. Length of total sick leave [12 months follow up after IPRP]

    Length of total sick leave during study period

  8. Pain intensity last 7 days [Baseline and 12 months]

    Numeric rating scale

  9. Consequences of pain on daily life [Baseline and 12 months]

    Multidimensional Pain Inventory Swedish version

  10. Overall emotional distress [Baseline and 12 months]

    Hospital Anxiety and Depression Scale Swedish version

  11. Physical and mental health [Baseline and 12 months]

    RAND-36 Swedish version

  12. Goal fulfilment and satisfaction during the study period [Baseline and 12 months]

    Self-reported data

  13. Self-reported physical work environment [Baseline and 12 months]

    Questionnaire based on the Swedish Work Environment Authority ergonomics checklist

Other Outcome Measures

  1. Self-reported fatigue the last 7 days [Baseline and 12 months]

    Numeric rating scale

  2. Self-reported level of sleepiness [Baseline and 12 months]

    Karolinska Sleepiness Scale Swedish version

  3. Self-reported level of sleep disturbance [Baseline and 12 months]

    Insomnia Severity Index Swedish version

  4. Self-reported fear of movement [Baseline and 12 months]

    Tampa Scale for Kinesiophobia Swedish version

  5. Self-reported physical activity [Baseline and 12 months]

    the National Board of Health and Welfare's three questions on physical activity, exercise, and sedentary behavior.

  6. Pain catastrophizing [Baseline and 12 months]

    Pain Catastrophizing scale Swedish version

  7. Perceived work ability [Baseline and 12 months]

    Work Ability Index Swedish version

  8. Self-reported demands, control, and support at the workplace [Baseline and 12 months]

    Demand Control Support Questionnaire Swedish version

  9. Perceived life Satisfaction [Baseline and 12 months]

    Life satisfaction Scale Swedish version

  10. Self-reported work situation during the study period [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 [Baseline and 12 months]

    Number of hours per day for paid work and unpaid household work

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Danderyd hospital Danderyd Sweden 182 57
2 Smärtcentrum Karlstad Sweden
3 County council of Ostergotland Linköping Sweden 581 83
4 Smärtcentrum Lund Sweden
5 Spine Center Stockholm Sweden

Sponsors and Collaborators

  • Linkoeping University
  • Swedish Council for Working Life and Social Research

Investigators

  • Principal Investigator: Mathilda Björk, PhD, Linkoeping University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mathilda Björk, Deputy Head of Department, Professor, Linkoeping University
ClinicalTrials.gov Identifier:
NCT05058547
Other Study ID Numbers:
  • Dnr 2019-01264
First Posted:
Sep 27, 2021
Last Update Posted:
Mar 25, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mathilda Björk, Deputy Head of Department, Professor, Linkoeping University
collaboration support
eHealth
employer support
smartphone application
return to work
self-management
Additional relevant MeSH terms:
Chronic Pain

Study Results

No Results Posted as of Mar 25, 2022