protocolSection identificationModule nctId: NCT06305819, orgStudyIdInfo id: 2023057, briefTitle: Effectiveness of a Self-management Program After Traumatic Injury, acronym: SEMPO, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2030-12-31, completionDateStruct date: 2030-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Oslo University Hospital, class: OTHER, collaborators name: South-Eastern Norway Regional Health Authority, collaborators name: Sunnaas Rehabilitation Hospital, collaborators name: University of Oslo, descriptionModule briefSummary: Traumatic injuries, defined as a physical injury with sudden onset, are a leading cause to disability and impaired health. Persons who sustain a traumatic injury often report problems in daily life activities and reduced quality of life, which may limit participation in work/studies, leisure activities and family life. Consequently, complex rehabilitation and support is recommended in National Trauma guidelines due to the often long-lasting physical and psychological sequela of the injury.The main goal of this study is to determine the effectiveness of a self-management support program delivered to persons with a moderate or severe traumatic injury in the sub-acute phase of recovery (i.e. 3-4 months after injury). The self-management program aims to enhance patients' self-efficacy by building skills and self-management strategies to cope with injury-related consequences. The program has a group-based format and consists of eight sessions comprising psychoeducation, skill mastery and sharing of experiences. The participants who will be included in the study must be between 18 and 70 years, be residing in the southeast region of Norway, be admitted to Oslo University hospital or transferred from local hospital within 72 hours after injury, have at least a two-day hospital stay, and be able to read and understand Norwegian language. Participants will be randomly assigned to either intervention or control group. A group of patients will also be able to self-select if they want to receive the self-management support program or be in the control group. The latter is an explorative part of the study to evaluate the influence of patients' treatment-preferences on the study outcomes. Participants in the control group will receive treatment as usual., conditionsModule conditions: Trauma Injury, conditions: Trauma, Multiple, conditions: Polytrauma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 220, type: ESTIMATED, armsInterventionsModule interventions name: self-management support program, interventions name: Control group, outcomesModule primaryOutcomes measure: Trauma Coping Self-Efficacy, secondaryOutcomes measure: Rivermead Post-Concussion Symptom Questionnaire, secondaryOutcomes measure: Fatigue Severity Scale, secondaryOutcomes measure: Insomnia Severity Index, secondaryOutcomes measure: Brief Pain Inventory -short form, secondaryOutcomes measure: International Physical Activity Questionnaire, secondaryOutcomes measure: Cognitive Failures Questionnaire, secondaryOutcomes measure: Patient Health Questionnaire-9, secondaryOutcomes measure: Generalised Anxiety Disorder-7, secondaryOutcomes measure: Impact of Event Scale - Revised, secondaryOutcomes measure: Return to work, otherOutcomes measure: Resilience Scale for Adults, otherOutcomes measure: EuroQol five-dimensional questionnaire, otherOutcomes measure: Target Outcomes, otherOutcomes measure: Patient Global Impression of Change, otherOutcomes measure: Intervention acceptability and satisfaction, otherOutcomes measure: Intervention satisfaction, otherOutcomes measure: WHO Disability Assessment Scale, otherOutcomes measure: Glasgow Outcome Scale - Extended, otherOutcomes measure: Communication with physicians, otherOutcomes measure: Health Literacy Questionnaire, otherOutcomes measure: Received health care services, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 72 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Oslo University Hospital, status: RECRUITING, city: Oslo, country: Norway, contacts name: Mari Storli Rasmussen, PhD, role: CONTACT, phone: +4799797575, email: masras@ous-hf.no, contacts name: Solveig L. Hauger, PhD, role: CONTACT, phone: +4791310358, email: solveig.hauger@gmail.com, geoPoint lat: 59.91273, lon: 10.74609, hasResults: False