Effectiveness of a Self-management Program After Traumatic Injury

ConditionsTrauma Injury Trauma, Multiple Polytrauma

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-72

SponsorOslo University Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

self-management support program
Behavioral
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.
Control group
Other intervention
Treatment as usual

Treatment groups

220 Participants

are divided into 2 treatment groups

Group A: InterventionExperimental treatment 1 intervention

Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

Trauma Coping Self-Efficacy

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).

Time frame