NCT06305819 Effectiveness of a Self-management Program After Traumatic Injury
| NCT ID | NCT06305819 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oslo University Hospital |
| Condition | Trauma Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 220 participants in total. It began in 2024-01-01 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Adults residing in the southeast region of Norway who are aged between 18 and 72 years. * Admitted to OUH directly or after transfer from local hospitals within 72 hours of injury. * At least a two-day hospital stay. * Traumatic injury corresponding to a New Injury Severity Scale score (NISS) \>9. * Patients reporting injury-related symptoms, functional impairments, and/or difficulties with daily activities at the discharge from OUH. Exclusion Criteria: * Cognitive function corresponding to a Mini Mental Status score (MMS) \< 20 points. * Psychiatric diseases that require treatment. * Drug/alcohol dependence that require treatment. * Complete spinal cord injury and isolated thoracic or abdominal injury * Insufficient command of Norwegian
Contact & Investigator
Nada Andelic
STUDY CHAIR
Oslo University Hospital
Frequently Asked Questions
Who can join the NCT06305819 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 72 Years, studying Trauma Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06305819 currently recruiting?
Yes, NCT06305819 is actively recruiting participants. Contact the research team at nadand@ous-hf.no for enrollment information.
Where is the NCT06305819 trial being conducted?
This trial is being conducted at Oslo, Norway.
Who is sponsoring the NCT06305819 clinical trial?
NCT06305819 is sponsored by Oslo University Hospital. The principal investigator is Nada Andelic at Oslo University Hospital. The trial plans to enroll 220 participants.