[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539590":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":48,"responsibleParty":66,"collaborators":69,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":27,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":42,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":97,"overallStatus":50,"whyStopped":42,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Oslo University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","Participants assigned to intervention arm will receive the self-management support program. The program consists of 2.5-hour sessions and is delivered to groups of 5-7 participants. The intervention is provided over a period of eight weeks with one session per week and is delivered by a multidisciplinary team. A tele-health version of the intervention will be offered to those who prefer to participate via electronic devices.",[13],"Behavioral: self-management support program",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","ACTIVE_COMPARATOR","Participants assigned to the control group will receive the usual health and rehabilitation services provided in the municipality or other rehabilitation settings. These services will potentially vary greatly from no services to specialized or local rehabilitation teams. All services received by participants in the control group will be registered at the follow-ups.",[19],"Other: Control group",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","self-management support program","The SEMPO program is inspired by established self-management principles and established rehabilitation strategies. The program is manualized and integrates components from rehabilitation strategies within relevant functional domains. The program includes elements, such as tailored psychoeducational content, action planning, guided skills mastery, learning and practicing helpful compensatory strategies, problem solving techniques and sharing of experiences. The intervention is delivered by a multidisciplinary team and the participants are provided with written materials and a work book containing information about each session and work tasks.",[9],[27],"SEMPO",{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Control group","Treatment as usual",[15],[15],[34],{"name":35,"affiliation":5,"role":36},"Nada Andelic","STUDY_CHAIR",[38,44],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Nada Andelic, PhD","CONTACT","+4791817910",null,"nadand@ous-hf.no",{"name":45,"role":40,"phone":46,"phoneExt":42,"email":47},"Mari Storli Rasmussen, PhD","+4799797575","masras@ous-hf.no",[49],{"facility":5,"status":50,"city":51,"state":42,"zip":42,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Oslo","Norway","NO",{"type":55,"coordinates":56},"Point",[57,58],10.74609,59.91273,{"lat":58,"lon":57},[61,62],{"name":45,"role":40,"phone":46,"phoneExt":42,"email":47},{"name":63,"role":40,"phone":64,"phoneExt":42,"email":65},"Solveig L. Hauger, PhD","+4791310358","solveig.hauger@gmail.com",{"type":67,"investigatorFullName":35,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"PRINCIPAL_INVESTIGATOR","Head of Research and Development",[70,72,74],{"name":71,"class":6},"South-Eastern Norway Regional Health Authority",{"name":73,"class":6},"Sunnaas Rehabilitation Hospital",{"name":75,"class":6},"University of Oslo","100539590","effectiveness-of-a-self-management-program-after-traumatic-injury-100539590",false,"NCT06305819","Effectiveness of a Self-management Program After Traumatic Injury","Managing Symptoms and Disability in the Sub-acute Phase After Traumatic Injury - A Pragmatic Randomised Controlled Trial of a Self-management Support Program","Inclusion Criteria:\n\n* Adults residing in the southeast region of Norway who are aged between 18 and 72 years.\n* Admitted to OUH directly or after transfer from local hospitals within 72 hours of injury.\n* At least a two-day hospital stay.\n* Traumatic injury corresponding to a New Injury Severity Scale score (NISS) \\>9.\n* Patients reporting injury-related symptoms, functional impairments, and\u002For difficulties with daily activities at the discharge from OUH.\n\nExclusion Criteria:\n\n* Cognitive function corresponding to a Mini Mental Status score (MMS) \\\u003C 20 points.\n* Psychiatric diseases that require treatment.\n* Drug\u002Falcohol dependence that require treatment.\n* Complete spinal cord injury and isolated thoracic or abdominal injury\n* Insufficient command of Norwegian","ALL","18 Years","72 Years",{"count":87,"type":88},220,"ESTIMATED","INTERVENTIONAL",[91],"NA","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\u002Fstudies, 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.\n\nThe 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.",[94,95,96],"Trauma Injury","Trauma, Multiple","Polytrauma",[98,99,100],"Self-management program","Rehabilitation","Sub-acute phase","2024-04-10",{"date":103,"type":104},"2024-04-12","ACTUAL",{"date":106,"type":104},"2024-01-01",{"date":108,"type":88},"2030-12-31",{"name":5,"class":6},1]