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.
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