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A pragmatic randomized controlled trial of a self-management support program

Managing symptoms and disability in the sub-acute phase after traumatic injury

Project PI

Nada Andelic (MD OUS, Prof. UiO)

Co-PIs

Solveig L. Hauger (SRH/UiO), Mari S. Rasmussen (OUS/OsloMet)

Abstract

Traumatic injuries are a major cause of distress and disability. A significant proportion of trauma survivors report problems and impaired health years after the injury. Preliminary results from an ongoing Helse Sør-Øst (HSØ)-funded follow-up study on rehabilitation service provision after trauma indicate that 77% and 70% of participants present with impairment and disability at six and twelve months post-injury, respectively. Participants report prolonged problems with physical, cognitive, and emotional functioning, as well as pain, fatigue, sleep impairment, and reduced participation.  

This randomized control trial aims to evaluate the effectiveness of a group-based Self-Management Support (SMS) program in patients with moderate to severe traumatic injury who are at high risk of developing persistent symptoms and disabilities. The SMS program will be delivered 3-4 months post-injury (sub-acute phase). The aim is to enhance self-efficacy through psychoeducation, skill training and self-management strategies to cope with injury-related consequences. Adults with moderate to severe traumatic injury who report injury related symtpoms 3-4 months post injury will be recruited from Oslo University hospital. Patients will be randomized to a randomization arm (RA) or a self-selection arm (SA). Participants in the RA will be further randomized to intervention or control group. In the self-selection arm, the participants will choose whether they will be placed in the intervention or control group. The SMS program will be provided through eight weekly 2.5-hour sessions in groups of 5–7 participants, face-to-face or in telehealth format. The control group will receive treatment as usual. Outcomes will be measured at baseline, post-intervention, and at three and six months post-intervention. The primary outcome measure is the Trauma Coping Self-Efficacy Scale. All participants will complete secondary outcome measures of symptom burden, functioning, communication, and health-literacy. Additionally, participants will be asked to self-select one domain-related measure as their preferred outcome. 
 

The project is a collaboration between Oslo University Hospital (OUH), Sunnaas Rehabilitation Hospital (SRH), Telemark Hospital, Oslo Municipality, and the University of Oslo (UiO). OUH is the project owner.  

Nada Andelic (MD OUS, Prof. UiO), PI, co-supervisor

Solveig L. Hauger (specialist in clinical neuropsychology SRH/ Ass. Prof. UiO), Co-PI, main supervisor

Mari S. Rasmussen, (physiotherapist OUH/ Ass. Prof. OsloMet), Co-PI, main supervisor 

PhD Students: Vilde Danielsen (OUS/SRH), Joanna Selj (OUS) 

Marianne Løvstad (prof. UiO/head psychologist SRH), co-supervisor

Emilie I. Howe (post doc. Neuropsychologist OUH) co-supervisor  

Cecilie Røe, MD, chief physician, dept of phys. Med. & rehab, OUH, co-supervisor

Helene L. Søberg, PT (OUH), Prof. OsloMet, co-supervisor

Eline Aas, health economist (Norwegian Institute of Public Health/UiO)

Ass. Prof. Randi Dovland Andersen, special advisor (Telemark Hospital/UiO)

Linda Narvestad, coordinating nurse, rehabilitation team (Oslo Municipality)

Profs. Eirik Helseth, Pål Aksel Næss, Christina Gaarder, Olav Røise, Unni Sveen, Mads Aarhus, OUH

Clinicians and reserachers: Silje Fure (MD), Hilde M. Dahl (MD), Håkon Moksnes (MD), Torgeir Hellstrøm (MD) and John Andreas Bjørneboe (MD), statistician Cathrine Brunborg (all from OUH) and Hege Prag Øra (SRH/UIO)  

International collaborations:

Prof. Juan Lu, Virginia Commonwealth University

Prof. Jennie Ponsford, Monash University Melbourne, Australia

Prof. Marie Elf, Dalarna University, Sweden

Prof. Fiona Jones, St Georges University of London 

Ethical approvals

REK, number 614625, approved by Data Protection Officer OUH.

Funding

South-Eastern Norway Regional Health Authority, 9 mill NOK

Time Period

August 1st 2023 until July 31st 2030 

Last updated 12/10/2023