A Digital Support to Facilitate Sustainable Return to Work for Persons With Chronic Pain and Their Employers (SWEPPE)
9 de marzo de 2022 actualizado por: 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).
Descripción general del estudio
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
360
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Mathilda Björk, PhD
- Número de teléfono: +4611363531
- Correo electrónico: mathilda.bjork@liu.se
Ubicaciones de estudio
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Danderyd, Suecia, 182 57
- Reclutamiento
- Danderyd Hospital
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Karlstad, Suecia
- Aún no reclutando
- Smärtcentrum
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Linköping, Suecia, 581 83
- Reclutamiento
- County council of Ostergotland
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Lund, Suecia
- Aún no reclutando
- Smärtcentrum
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Stockholm, Suecia
- Aún no reclutando
- Spine Center
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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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Sin intervención: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Sick leave
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Return to work
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Self-reported fatigue the last 7 days
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Mathilda Björk, PhD, Linkoeping University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
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- Harker J, Reid KJ, Bekkering GE, Kellen E, Bala MM, Riemsma R, Worthy G, Misso K, Kleijnen J. Epidemiology of chronic pain in denmark and sweden. Pain Res Treat. 2012;2012:371248. doi: 10.1155/2012/371248. Epub 2012 May 23.
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- Perez C, Margarit C, Sanchez-Magro I, de Antonio A, Villoria J. Chronic Pain Features Relate to Quality of Life More than Physiopathology: A Cross-Sectional Evaluation in Pain Clinics. Pain Pract. 2017 Sep;17(7):866-878. doi: 10.1111/papr.12533. Epub 2017 Feb 25.
- Gerdle B, Bjork J, Henriksson C, Bengtsson A. Prevalence of current and chronic pain and their influences upon work and healthcare-seeking: a population study. J Rheumatol. 2004 Jul;31(7):1399-406.
- 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.
- Asmundson GJ, Katz J. Understanding the co-occurrence of anxiety disorders and chronic pain: state-of-the-art. Depress Anxiety. 2009;26(10):888-901. doi: 10.1002/da.20600.
- Shupler MS, Kramer JK, Cragg JJ, Jutzeler CR, Whitehurst DGT. Pan-Canadian Estimates of Chronic Pain Prevalence From 2000 to 2014: A Repeated Cross-Sectional Survey Analysis. J Pain. 2019 May;20(5):557-565. doi: 10.1016/j.jpain.2018.10.010. Epub 2018 Nov 29.
- 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.
- Saunders SL, Nedelec B. What work means to people with work disability: a scoping review. J Occup Rehabil. 2014 Mar;24(1):100-10. doi: 10.1007/s10926-013-9436-y.
- Grant M, O-Beirne-Elliman J, Froud R, Underwood M, Seers K. The work of return to work. Challenges of returning to work when you have chronic pain: a meta-ethnography. BMJ Open. 2019 Jun 20;9(6):e025743. doi: 10.1136/bmjopen-2018-025743.
- 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
- Cohen D, Allen J, Rhydderch M, Aylward M. The return to work discussion: a qualitative study of the line manager conversation about return to work and the development of an educational programme. J Rehabil Med. 2012 Jul;44(8):677-83. doi: 10.2340/16501977-0996.
- Scott W, Chilcot J, Guildford B, Daly-Eichenhardt A, McCracken LM. Feasibility randomized-controlled trial of online Acceptance and Commitment Therapy for patients with complex chronic pain in the United Kingdom. Eur J Pain. 2018 Apr 28. doi: 10.1002/ejp.1236. Online ahead of print.
- Coutu MF, Legare F, Durand MJ, Stacey D, Labrecque ME, Corbiere M, Bainbridge L. Acceptability and Feasibility of a Shared Decision-Making Model in Work Rehabilitation: A Mixed-Methods Study of Stakeholders' Perspectives. J Occup Rehabil. 2019 Mar;29(1):128-139. doi: 10.1007/s10926-018-9770-1.
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- Ledel Solem IK, Varsi C, Eide H, Kristjansdottir OB, Borosund E, Schreurs KMG, Waxenberg LB, Weiss KE, Morrison EJ, Haaland-Overby M, Bevan K, Zangi HA, Stubhaug A, Solberg Nes L. A User-Centered Approach to an Evidence-Based Electronic Health Pain Management Intervention for People With Chronic Pain: Design and Development of EPIO. J Med Internet Res. 2020 Jan 21;22(1):e15889. doi: 10.2196/15889.
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- Ledel Solem IK, Varsi C, Eide H, Kristjansdottir OB, Mirkovic J, Borosund E, Haaland-Overby M, Heldal K, Schreurs KM, Waxenberg LB, Weiss KE, Morrison EJ, Solberg Nes L. Patients' Needs and Requirements for eHealth Pain Management Interventions: Qualitative Study. J Med Internet Res. 2019 Apr 1;21(4):e13205. doi: 10.2196/13205.
- Timmers T, Janssen L, Kool RB, Kremer JA. Educating Patients by Providing Timely Information Using Smartphone and Tablet Apps: Systematic Review. J Med Internet Res. 2020 Apr 13;22(4):e17342. doi: 10.2196/17342.
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- Morton K, Dennison L, May C, Murray E, Little P, McManus RJ, Yardley L. Using digital interventions for self-management of chronic physical health conditions: A meta-ethnography review of published studies. Patient Educ Couns. 2017 Apr;100(4):616-635. doi: 10.1016/j.pec.2016.10.019. Epub 2016 Oct 20.
- Coe-O'Brien R, Joseph L, Kuisma R, Paungmali A, Sitilertpisan P, Pirunsan U. Outcome measures used in the smartphone applications for the management of low back pain: a systematic scoping review. Health Inf Sci Syst. 2020 Jan 2;8(1):5. doi: 10.1007/s13755-019-0097-x. eCollection 2020 Dec.
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de marzo de 2022
Finalización primaria (Anticipado)
1 de diciembre de 2023
Finalización del estudio (Anticipado)
1 de diciembre de 2024
Fechas de registro del estudio
Enviado por primera vez
24 de septiembre de 2021
Primero enviado que cumplió con los criterios de control de calidad
24 de septiembre de 2021
Publicado por primera vez (Actual)
27 de septiembre de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de marzo de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
9 de marzo de 2022
Última verificación
1 de marzo de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Dnr 2019-01264
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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