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

NCT05058547 | Unknown

• 1 other identifier: Dnr 2019-01264
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 5

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).

Conditions

Chronic Pain

Keywords

collaboration support; eHealth; employer support; smartphone application; return to work; self-management

Outcome Measures

Primary Outcomes (1)

• Sick leave

  Number of gross and net days with sickness cash benefit

  12 months follow up after IPRP

Secondary Outcomes (13)

• Return to work

  12 months follow up after IPRP

• Sick-leave spells per months

  12 months follow up after IPRP

• Return to work group level

  12 months follow up after IPRP

• Working days before new sick leave

  12 months follow up after IPRP

• Proportion back to work

  12 months follow up after IPRP

Other Outcomes (11)

• Self-reported fatigue the last 7 days

  Baseline and 12 months

• Self-reported level of sleepiness

  Baseline and 12 months

• Self-reported level of sleep disturbance

  Baseline and 12 months

Study Arms (2)

SWEPPE

EXPERIMENTAL

Participants will receive the smartphone application SWEPPE.

Device: SWEPPE

Control

NO INTERVENTION

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

Interventions

SWEPPE 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.

SWEPPE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Completed IPRP but are unemployed or unable to return to work.

Sponsors & Collaborators

• Linkoeping University: lead
• Swedish Council for Working Life and Social Research: collaborator

Study Sites (5)

Danderyd hospital

Danderyd, 182 57, Sweden

RECRUITING

Smärtcentrum

Karlstad, Sweden

NOT YET RECRUITING

County council of Ostergotland

Linköping, 581 83, Sweden

RECRUITING

Smärtcentrum

Lund, Sweden

NOT YET RECRUITING

Spine Center

Stockholm, Sweden

NOT YET RECRUITING

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MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mathilda Björk, PhD

  Linkoeping University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mathilda Björk, PhD

CONTACT

+4611363531; mathilda.bjork@liu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Head of Department, Professor

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: September 27, 2021
• Study Start: March 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: March 25, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (5)