Effectiveness of a Self-management Program After Traumatic Injury

NCT06305819 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2024-04-12

No results posted yet for this study

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.

Conditions

  • Trauma Injury
  • Trauma, Multiple
  • Polytrauma

Interventions

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.

OTHER

Control group

Treatment as usual

Sponsors & Collaborators

  • South-Eastern Norway Regional Health Authority

    collaborator OTHER
  • Sunnaas Rehabilitation Hospital

    collaborator OTHER
  • University of Oslo

    collaborator OTHER
  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Nada Andelic · Oslo University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
72 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2030-12-31
Completion
2030-12-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06305819 on ClinicalTrials.gov