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

Primary Purpose

Chronic Pain

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
SWEPPE
Sponsored by
Linkoeping University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring collaboration support, eHealth, employer support, smartphone application, return to work, self-management

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Danderyd hospitalRecruiting
  • Smärtcentrum
  • County council of OstergotlandRecruiting
  • Smärtcentrum
  • Spine Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SWEPPE

Control

Arm Description

Participants will receive the smartphone application SWEPPE.

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

Outcomes

Primary Outcome Measures

Sick leave
Number of gross and net days with sickness cash benefit

Secondary Outcome Measures

Return to work
Return to work (partially or full time) every month
Sick-leave spells per months
Number of sick-leave spells (per month)
Return to work group level
Proportions of a group who returns to full- or part-time work (per month)
Working days before new sick leave
Number of days in work before new sick leave during study period
Proportion back to work
Proportion of a group back to work >28 days (full- or part time) before a new sick-leave spell occurs
Total sick-leave spells
Number of sick-leave spells during study period
Length of total sick leave
Length of total sick leave during study period
Pain intensity last 7 days
Numeric rating scale
Consequences of pain on daily life
Multidimensional Pain Inventory Swedish version
Overall emotional distress
Hospital Anxiety and Depression Scale Swedish version
Physical and mental health
RAND-36 Swedish version
Goal fulfilment and satisfaction during the study period
Self-reported data
Self-reported physical work environment
Questionnaire based on the Swedish Work Environment Authority ergonomics checklist

Full Information

First Posted
September 24, 2021
Last Updated
March 9, 2022
Sponsor
Linkoeping University
Collaborators
Swedish Council for Working Life and Social Research
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1. Study Identification

Unique Protocol Identification Number
NCT05058547
Brief Title
A Digital Support to Facilitate Sustainable Return to Work for Persons With Chronic Pain and Their Employers
Acronym
SWEPPE
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linkoeping University
Collaborators
Swedish Council for Working Life and Social Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
collaboration support, eHealth, employer support, smartphone application, return to work, self-management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SWEPPE
Arm Type
Experimental
Arm Description
Participants will receive the smartphone application SWEPPE.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants randomized to the control group will not receive any active intervention for return to work after completing an Interdisciplinary Pain Rehabilitation Program .
Intervention Type
Device
Intervention Name(s)
SWEPPE
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sick leave
Description
Number of gross and net days with sickness cash benefit
Time Frame
12 months follow up after IPRP
Secondary Outcome Measure Information:
Title
Return to work
Description
Return to work (partially or full time) every month
Time Frame
12 months follow up after IPRP
Title
Sick-leave spells per months
Description
Number of sick-leave spells (per month)
Time Frame
12 months follow up after IPRP
Title
Return to work group level
Description
Proportions of a group who returns to full- or part-time work (per month)
Time Frame
12 months follow up after IPRP
Title
Working days before new sick leave
Description
Number of days in work before new sick leave during study period
Time Frame
12 months follow up after IPRP
Title
Proportion back to work
Description
Proportion of a group back to work >28 days (full- or part time) before a new sick-leave spell occurs
Time Frame
12 months follow up after IPRP
Title
Total sick-leave spells
Description
Number of sick-leave spells during study period
Time Frame
12 months follow up after IPRP
Title
Length of total sick leave
Description
Length of total sick leave during study period
Time Frame
12 months follow up after IPRP
Title
Pain intensity last 7 days
Description
Numeric rating scale
Time Frame
Baseline and 12 months
Title
Consequences of pain on daily life
Description
Multidimensional Pain Inventory Swedish version
Time Frame
Baseline and 12 months
Title
Overall emotional distress
Description
Hospital Anxiety and Depression Scale Swedish version
Time Frame
Baseline and 12 months
Title
Physical and mental health
Description
RAND-36 Swedish version
Time Frame
Baseline and 12 months
Title
Goal fulfilment and satisfaction during the study period
Description
Self-reported data
Time Frame
Baseline and 12 months
Title
Self-reported physical work environment
Description
Questionnaire based on the Swedish Work Environment Authority ergonomics checklist
Time Frame
Baseline and 12 months
Other Pre-specified Outcome Measures:
Title
Self-reported fatigue the last 7 days
Description
Numeric rating scale
Time Frame
Baseline and 12 months
Title
Self-reported level of sleepiness
Description
Karolinska Sleepiness Scale Swedish version
Time Frame
Baseline and 12 months
Title
Self-reported level of sleep disturbance
Description
Insomnia Severity Index Swedish version
Time Frame
Baseline and 12 months
Title
Self-reported fear of movement
Description
Tampa Scale for Kinesiophobia Swedish version
Time Frame
Baseline and 12 months
Title
Self-reported physical activity
Description
the National Board of Health and Welfare's three questions on physical activity, exercise, and sedentary behavior.
Time Frame
Baseline and 12 months
Title
Pain catastrophizing
Description
Pain Catastrophizing scale Swedish version
Time Frame
Baseline and 12 months
Title
Perceived work ability
Description
Work Ability Index Swedish version
Time Frame
Baseline and 12 months
Title
Self-reported demands, control, and support at the workplace
Description
Demand Control Support Questionnaire Swedish version
Time Frame
Baseline and 12 months
Title
Perceived life Satisfaction
Description
Life satisfaction Scale Swedish version
Time Frame
Baseline and 12 months
Title
Self-reported work situation during the study period
Description
Barriers for return to work, strategies to handle barriers and need of support from the employer
Time Frame
Baseline and 12 months
Title
Self-reported workload an average day
Description
Number of hours per day for paid work and unpaid household work
Time Frame
Baseline and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mathilda Björk, PhD
Phone
+4611363531
Email
mathilda.bjork@liu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathilda Björk, PhD
Organizational Affiliation
Linkoeping University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Danderyd hospital
City
Danderyd
ZIP/Postal Code
182 57
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Smärtcentrum
City
Karlstad
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Name
County council of Ostergotland
City
Linköping
ZIP/Postal Code
581 83
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Smärtcentrum
City
Lund
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Name
Spine Center
City
Stockholm
Country
Sweden
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
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A Digital Support to Facilitate Sustainable Return to Work for Persons With Chronic Pain and Their Employers

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