A Digital Support to Facilitate Sustainable Return to Work for Persons With Chronic Pain and Their Employers (SWEPPE)
2022. március 9. frissítette: Mathilda Björk, Linkoeping University
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.
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).
A tanulmány áttekintése
Tanulmány típusa
Beavatkozó
Beiratkozás (Várható)
360
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi kapcsolat
- Név: Mathilda Björk, PhD
- Telefonszám: +4611363531
- E-mail: mathilda.bjork@liu.se
Tanulmányi helyek
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Danderyd, Svédország, 182 57
- Toborzás
- Danderyd Hospital
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Karlstad, Svédország
- Még nincs toborzás
- Smärtcentrum
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Linköping, Svédország, 581 83
- Toborzás
- County council of Ostergotland
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Lund, Svédország
- Még nincs toborzás
- Smärtcentrum
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Stockholm, Svédország
- Még nincs toborzás
- Spine Center
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
18 év (Felnőtt, Idősebb felnőtt)
Egészséges önkénteseket fogad
Nem
Tanulmányozható nemek
Összes
Leírás
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.
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Egyetlen
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Kísérleti: SWEPPE
Participants will receive the smartphone application SWEPPE.
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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.
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Nincs beavatkozás: Control
Participants randomized to the control group will not receive any active intervention for return to work after completing an Interdisciplinary Pain Rehabilitation Program .
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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Sick leave
Időkeret: 12 months follow up after IPRP
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Number of gross and net days with sickness cash benefit
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12 months follow up after IPRP
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Return to work
Időkeret: 12 months follow up after IPRP
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Return to work (partially or full time) every month
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12 months follow up after IPRP
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Sick-leave spells per months
Időkeret: 12 months follow up after IPRP
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Number of sick-leave spells (per month)
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12 months follow up after IPRP
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Return to work group level
Időkeret: 12 months follow up after IPRP
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Proportions of a group who returns to full- or part-time work (per month)
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12 months follow up after IPRP
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Working days before new sick leave
Időkeret: 12 months follow up after IPRP
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Number of days in work before new sick leave during study period
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12 months follow up after IPRP
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Proportion back to work
Időkeret: 12 months follow up after IPRP
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Proportion of a group back to work >28 days (full- or part time) before a new sick-leave spell occurs
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12 months follow up after IPRP
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Total sick-leave spells
Időkeret: 12 months follow up after IPRP
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Number of sick-leave spells during study period
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12 months follow up after IPRP
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Length of total sick leave
Időkeret: 12 months follow up after IPRP
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Length of total sick leave during study period
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12 months follow up after IPRP
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Pain intensity last 7 days
Időkeret: Baseline and 12 months
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Numeric rating scale
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Baseline and 12 months
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Consequences of pain on daily life
Időkeret: Baseline and 12 months
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Multidimensional Pain Inventory Swedish version
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Baseline and 12 months
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Overall emotional distress
Időkeret: Baseline and 12 months
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Hospital Anxiety and Depression Scale Swedish version
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Baseline and 12 months
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Physical and mental health
Időkeret: Baseline and 12 months
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RAND-36 Swedish version
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Baseline and 12 months
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Goal fulfilment and satisfaction during the study period
Időkeret: Baseline and 12 months
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Self-reported data
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Baseline and 12 months
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Self-reported physical work environment
Időkeret: Baseline and 12 months
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Questionnaire based on the Swedish Work Environment Authority ergonomics checklist
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Baseline and 12 months
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Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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Self-reported fatigue the last 7 days
Időkeret: Baseline and 12 months
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Numeric rating scale
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Baseline and 12 months
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Self-reported level of sleepiness
Időkeret: Baseline and 12 months
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Karolinska Sleepiness Scale Swedish version
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Baseline and 12 months
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Self-reported level of sleep disturbance
Időkeret: Baseline and 12 months
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Insomnia Severity Index Swedish version
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Baseline and 12 months
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Self-reported fear of movement
Időkeret: Baseline and 12 months
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Tampa Scale for Kinesiophobia Swedish version
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Baseline and 12 months
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Self-reported physical activity
Időkeret: Baseline and 12 months
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the National Board of Health and Welfare's three questions on physical activity, exercise, and sedentary behavior.
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Baseline and 12 months
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Pain catastrophizing
Időkeret: Baseline and 12 months
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Pain Catastrophizing scale Swedish version
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Baseline and 12 months
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Perceived work ability
Időkeret: Baseline and 12 months
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Work Ability Index Swedish version
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Baseline and 12 months
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Self-reported demands, control, and support at the workplace
Időkeret: Baseline and 12 months
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Demand Control Support Questionnaire Swedish version
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Baseline and 12 months
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Perceived life Satisfaction
Időkeret: Baseline and 12 months
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Life satisfaction Scale Swedish version
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Baseline and 12 months
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Self-reported work situation during the study period
Időkeret: Baseline and 12 months
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Barriers for return to work, strategies to handle barriers and need of support from the employer
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Baseline and 12 months
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Self-reported workload an average day
Időkeret: Baseline and 12 months
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Number of hours per day for paid work and unpaid household work
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Baseline and 12 months
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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Együttműködők
Nyomozók
- Kutatásvezető: Mathilda Björk, PhD, Linkoeping University
Publikációk és hasznos linkek
A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.
Általános kiadványok
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- Caceres-Matos R, Gil-Garcia E, Barrientos-Trigo S, Porcel-Galvez AM, Cabrera-Leon A. Consequences of Chronic Non-Cancer Pain in adulthood. Scoping Review. Rev Saude Publica. 2020 Apr 17;54:39. doi: 10.11606/s1518-8787.2020054001675. eCollection 2020.
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- Svanholm F, Liedberg GM, Lofgren M, Bjork M. Factors of importance for return to work, experienced by patients with chronic pain that have completed a multimodal rehabilitation program - a focus group study. Disabil Rehabil. 2022 Mar;44(5):736-744. doi: 10.1080/09638288.2020.1780479. Epub 2020 Jun 25.
- Toye F, Seers K, Allcock N, Briggs M, Carr E, Barker K. A synthesis of qualitative research exploring the barriers to staying in work with chronic musculoskeletal pain. Disabil Rehabil. 2016;38(6):566-72. doi: 10.3109/09638288.2015.1049377.
- Liedberg GM, Bjork M, Dragioti E, Turesson C. Qualitative Evidence from Studies of Interventions Aimed at Return to Work and Staying at Work for Persons with Chronic Musculoskeletal Pain. J Clin Med. 2021 Mar 17;10(6):1247. doi: 10.3390/jcm10061247.
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- Turesson C, Liedberg G, Vixner L, Lofgren M, Bjork M. Evidence-based digital support during 1 year after an Interdisciplinary Pain Rehabilitation Programme for persons with chronic musculoskeletal pain to facilitate a sustainable return to work: a study protocol for a registry-based multicentre randomised controlled trial. BMJ Open. 2022 Apr 25;12(4):e060452. doi: 10.1136/bmjopen-2021-060452.
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
2022. március 1.
Elsődleges befejezés (Várható)
2023. december 1.
A tanulmány befejezése (Várható)
2024. december 1.
Tanulmányi regisztráció dátumai
Először benyújtva
2021. szeptember 24.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2021. szeptember 24.
Első közzététel (Tényleges)
2021. szeptember 27.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2022. március 25.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2022. március 9.
Utolsó ellenőrzés
2022. március 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- Dnr 2019-01264
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
NEM
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