Managing Symptoms and Disability in the Sub-acute Phase After Traumatic Injury - A Pragmatic Randomised Controlled Trial of a Self-management Support Program
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Trauma Coping Self-Efficacy
研究概览
简要总结
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.
详细描述
This study is designed as a pragmatic randomized controlled trial using a mixed-methods design with 6-months follow-up to determine the effectiveness of a newly developed self-management support program, entitled the SEMPO. Participants will be included 3-4 months post-injury and followed up over a 12 months period.
Study setting and participants:
The study will be conducted at Oslo University Hospital (OUH). Patients will be recruited at the Trauma Centre at Oslo University Hospital, which is the Level 1 trauma centre for the southeast region of Norway and serves a population base consisting of more than half of the Norwegian population. Patients who fulfil the following inclusion criteria will be asked to participate:
- 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. According to preliminary analyses in ongoing study on unmet needs after trauma (funded by South-Eastern Norway Regional Health Authority), these patients are in risk of developing long-lasting disabilities.
Patients will be excluded in case of:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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) >
- •Patients reporting injury-related symptoms, functional impairments, and/or difficulties with daily activities at the discharge from OUH.
排除标准
- •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
结局指标
主要结局
Trauma Coping Self-Efficacy
时间窗: Change from baseline (T1) to immediately after the intervention period (T2), 3 months after intervention (T3), and 6 months after intervention (T4)
Self-reported change in self-efficacy in trauma coping, measured on a 9-item questionnaire, with Likert scale from 1 (not capable) to 7 (totally capable).
次要结局
- Insomnia Severity Index(Change from baseline (T1) to immediately after the intervention period (T2), 3 months after intervention (T3), and 6 months after intervention (T4))
- Patient Health Questionnaire-9(Change from baseline (T1) to immediately after the intervention period (T2), 3 months after intervention (T3), and 6 months after intervention (T4))
- Rivermead Post-Concussion Symptom Questionnaire(Change from baseline (T1) to immediately after the intervention period (T2), 3 months after intervention (T3), and 6 months after intervention (T4))
- International Physical Activity Questionnaire(Change from baseline (T1) to immediately after the intervention period (T2), 3 months after intervention (T3), and 6 months after intervention (T4))
- Generalised Anxiety Disorder-7(Change from baseline (T1) to immediately after the intervention period (T2), 3 months after intervention (T3), and 6 months after intervention (T4))
- Impact of Event Scale - Revised(Change from baseline (T1) to immediately after the intervention period (T2), 3 months after intervention (T3), and 6 months after intervention (T4))
- Fatigue Severity Scale(Change from baseline (T1) to immediately after the intervention period (T2), 3 months after intervention (T3), and 6 months after intervention (T4))
- Cognitive Failures Questionnaire(Change from baseline (T1) to immediately after the intervention period (T2), 3 months after intervention (T3), and 6 months after intervention (T4))
- Brief Pain Inventory -short form(Change from baseline (T1) to immediately after the intervention period (T2), 3 months after intervention (T3), and 6 months after intervention (T4))
- Return to work(Change from baseline (T1) to immediately after the intervention period (T2), 3 months after intervention (T3), and 6 months after intervention (T4))
研究者
Nada Andelic
Head of Research and Development
Oslo University Hospital