Effectiveness of a Self-management Program After Traumatic Injury

NCT06305819 | Recruiting

• 1 other identifier: 2023057
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma Injury; Trauma, Multiple; Polytrauma

Keywords

Self-management program; Rehabilitation; Sub-acute phase

Outcome Measures

Primary Outcomes (1)

• 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).

  Change from baseline (T1) to immediately after the intervention period (T2), 3 months after intervention (T3), and 6 months after intervention (T4)

Secondary Outcomes (10)

• 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)

• 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)

• 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)

• 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)

• 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)

Other Outcomes (11)

• Resilience Scale for Adults

  Change from baseline (T1) to immediately after the intervention period (T2), 3 months after intervention (T3), and 6 months after intervention (T4)

• EuroQol five-dimensional questionnaire

  Change from baseline (T1) to immediately after the intervention period (T2), 3 months after intervention (T3), and 6 months after intervention (T4)

• Target Outcomes

  Change from baseline (T1) to immediately after the intervention period (T2), 3 months after intervention (T3), and 6 months after intervention (T4)

Study Arms (2)

Intervention

EXPERIMENTAL

Participants assigned to intervention arm will receive the self-management support program. The program consists of 2.5-hour sessions and is delivered to groups of 5-7 participants. The intervention is provided over a period of eight weeks with one session per week and is delivered by a multidisciplinary team. A tele-health version of the intervention will be offered to those who prefer to participate via electronic devices.

Behavioral: self-management support program

Control

ACTIVE COMPARATOR

Participants assigned to the control group will receive the usual health and rehabilitation services provided in the municipality or other rehabilitation settings. These services will potentially vary greatly from no services to specialized or local rehabilitation teams. All services received by participants in the control group will be registered at the follow-ups.

Other: Control group

Interventions

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.

Also known as: SEMPO

Intervention

Control group OTHER

Treatment as usual

Also known as: Control

Control

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• South-Eastern Norway Regional Health Authority: collaborator
• Sunnaas Rehabilitation Hospital: collaborator
• University of Oslo: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, Norway

RECRUITING

Related Publications (1)

• Rasmussen MS, Andelic N, Selj JN, Danielsen VM, Lovstad M, Howe EI, Hellstrom T, Soberg HL, Brunborg C, Aas E, Moksnes H, Sveen U, Gaarder C, Naess PA, Helseth E, Roise O, Aarhus M, Ora HP, Bjorneboe JA, Fure S, Roe C, Schafer C, Perrin PB, Lu J, Elf M, Dahl HM, Jones F, Ponsford J, Narvestad L, Hauger SL. Self-management support program delivered in the sub-acute phase after traumatic injury-study protocol for a pragmatic randomized controlled trial. Trials. 2024 Sep 30;25(1):639. doi: 10.1186/s13063-024-08492-0.

  PMID: 39350137 DERIVED

MeSH Terms

Conditions

Accidental Injuries; Multiple Trauma

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Nada Andelic

  Oslo University Hospital

  STUDY CHAIR

Central Study Contacts

Nada Andelic, PhD

CONTACT

+4791817910; nadand@ous-hf.no

Mari Storli Rasmussen, PhD

CONTACT

+4799797575; masras@ous-hf.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research and Development

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 12, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)