[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613601":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":61,"collaborators":12,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":12,"enrollmentInfo":73,"targetDuration":12,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":90,"overallStatus":97,"whyStopped":12,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Haukeland University Hospital","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control group","NO_INTERVENTION","Standard treatment and follow up after trauma according to national guidelines in the National trauma plan.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Intervention group","ACTIVE_COMPARATOR","Tailored patient information and patient-managed outpatient follow up as an adjunct to standard treatment according to national guidelines in the National trauma plan",[18],"Other: The intervention is a tailored patient Information and Patient-managed Outpatient Digital follow-up treatment",[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"The intervention is a tailored patient Information and Patient-managed Outpatient Digital follow-up treatment","The objective of the POSTRAUMA-trial is to assess if the I-POD intervention combined with standard treatment according to national guidelines, lead to less disability measured by EQ5D-index, better health-related quality of life measured by EQ-VAS and increased return to studies and work compared to standard treatment after trauma.",[14],[25],"I-POD intervention",[27],{"name":28,"affiliation":29,"role":30},"Geir Arne Sunde, Ph.d","Haukeland University hospital, Surgical Department","PRINCIPAL_INVESTIGATOR",[32,37],{"name":33,"role":34,"phone":35,"phoneExt":12,"email":36},"Marianne Wesnes, Cand. med.","CONTACT","+47 996 20 649","marianne.wesnes@helse-bergen.no",{"name":38,"role":34,"phone":39,"phoneExt":12,"email":40},"Geir Arne Sunde, Ph.d.","+47 992 04 008","geir.arne.sunde@helse-bergen.no",[42],{"facility":43,"status":12,"city":44,"state":12,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Surgical Department, Haukeland University hospital","Bergen","5021","Norway","NO",{"type":49,"coordinates":50},"Point",[51,52],5.32415,60.39299,{"lat":52,"lon":51},[55,57,58,60],{"name":56,"role":34,"phone":35,"phoneExt":12,"email":36},"Marianne Wesnes, Cand.med",{"name":28,"role":34,"phone":39,"phoneExt":12,"email":40},{"name":56,"role":59,"phone":12,"phoneExt":12,"email":12},"SUB_INVESTIGATOR",{"name":28,"role":30,"phone":12,"phoneExt":12,"email":12},{"type":62,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100613601","assess-the-efficacy-of-tailored-patient-information-and-voluntary-patient-managed-outpatient-digital-follow-up-i-pod-as-an-adjunct-to-standard-treatment-according-to-national-guidelines-in-the-national-trauma-plan-among-adult-trauma-patients-in-norway-100613601",false,"NCT07268716","Assess the Efficacy of Tailored Patient Information and Voluntary Patient-managed Outpatient Digital Follow-up (I-POD) as an Adjunct to Standard Treatment According to National Guidelines in the National Trauma Plan Among Adult Trauma Patients in Norway.","A Randomized Controlled Clinical Trial to Assess the Efficacy of Tailored Patient Information and Voluntary Patient-Managed Outpatient Digital Follow-Up as an Adjunct to Standard Treatment According to National Guidelines in Adult Trauma Patients in Norway (The POSTRAUMA Trial).","POSTRAUMA","Inclusion Criteria:\n\n* 16 years or older\n* Fulfils the national criteria for TTA and admitted to HUS following trauma\n* Included in NTR database\n* Able to give informed consent\n\nExclusion Criteria:\n\n* 15 years or younger\n* Not included in NTR database\n* Deceased before discharge from the hospital.\n* Not able to give informed consent\n* Insufficient command of the Norwegian language\n* Foreign tourists or nationals\n* Suicide attempt or serious self-inflicted trauma\n* Serious psychiatric disorders or serious ongoing substance abuse","ALL","16 Years",{"count":74,"type":75},256,"ESTIMATED","INTERVENTIONAL",[78],"NA","The POSTRAUMA trial is a clinical trial at The Regional trauma centre of Western Norway, Haukeland University Hospital.\n\nTrauma is the leading cause of death worldwide in patients aged 1-45 years. In Norway, approximately 10,000 patients are admitted to hospital annually due to trauma, with 66% being male. The mean age is 43 years for male and 48 years for female, indicating a relatively young patient population.\n\nWhile mortality rates are decreasing, a significant proportion of trauma survivors experience long-term disabilities, reduced quality of life, and difficulties in returning to work. These consequences impose substantial burdens on individuals, families, and society. Considering these issues, a shift in focus is needed-from survival alone to long-term functional recovery and quality of life after trauma.\n\nSevere trauma often requires long-term follow-up, both physically and psychosocially. Traditional follow-up can be fragmented and not tailored to individual needs. Digital patient monitoring and tailored information have the potential to improve patient pathways, but knowledge about how these are experienced by patients is limited.\n\nThe goal is to find out if Norwegian trauma patients who receive tailored patient information and patient-managed outpatient digital follow-up, in addition to standard treatment have:\n\n* Less disability\n* Return more often to work\n* Improved quality of life\n\nThe study population are Norwegian trauma patients, 16 years or older at date of inclusion, who are admitted to Haukeland University hospital (HUS) following trauma with trauma team activation. 256 patients will be included in this trial.\n\nParticipants will:\n\n* Answer a questionnaire at inclusion, one month, 6 months and 12 months.\n* Participants in the intervention group will be invited to digital outpatient follow up one month after the accident.\n* Some participants will be interviewed about how they experienced their trauma follow up.",[81,82,83,84,85,86,87,88,89],"Trauma Centers","Trauma Patients","Trauma (Including Fractures)","Trauma Injury","Rehabilitation After Neurological or Orthopaedic Injuries","Rehabilitation","Return to Work","HRQOL (Health Related Quality Of Life)","EQ5D5L-VAS",[91,92,93,94,95,96],"multitrauma","trauma","rehabilitation","return to work","HRQOL","EQ5D","NOT_YET_RECRUITING","2025-12-16",{"date":100,"type":101},"2025-12-22","ACTUAL",{"date":103,"type":75},"2026-03-02",{"date":105,"type":75},"2029-12-31",{"name":5,"class":6},1]