Self-management support program delivered in the sub-acute phase after traumatic injury-study protocol for a pragmatic randomized controlled trial.
Mari S Rasmussen, Nada Andelic, Joanna Nordhagen Selj...
https://pubmed.ncbi.nlm.nih.gov/39350137Actively Recruiting
Phase Not Applicable
Age: 18Years - 72Years
All Genders
ID06305819
Managing Symptoms and Disability After Traumatic Injury Using a Self-management Support Program A Pragmatic Randomized Controlled Trial
Led by Oslo University Hospital · Updated on 2024-04-12
220
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
O
Oslo University Hospital
Lead Sponsor
S
South-Eastern Norway Regional Health Authority
Collaborating Sponsor
AI-Summary
What this Trial Is About
Traumatic injuries, which happen suddenly and can cause long-term disability and reduced quality of life, are the focus of this research. The study aims to assess the effectiveness of a self-management support program for adults aged 18 to 72 who have experienced moderate to severe traumatic injuries, especially those living in southeast Norway and admitted to Oslo University Hospital. The program is designed to help patients build skills and strategies to manage the physical and psychological effects of their injuries during the sub-acute recovery phase, about 3 to 4 months after injury. Participants will be randomly assigned to either receive the self-management support program or continue with their usual care. The support program consists of eight weekly 2.5-hour group sessions led by a multidisciplinary team, offered in-person or via tele-health for those who prefer remote participation. The control group will receive the typical rehabilitation services available in their local community, which may vary. During the 12-month study, participants will complete interviews and patient-reported outcome measures at four time points: before the program, immediately after, and at three and six months post-intervention. Researchers will evaluate self-efficacy in coping with trauma using a specific scale, along with secondary measures like symptom burden, physical and emotional functioning, and quality of life. All services received by the control group will be recorded to compare outcomes. The study also explores how allowing patients to choose their treatment group affects results and adherence.
CONDITIONS
Brief Title
Effectiveness of a Self-management Program After Traumatic Injury
Who Can Participate
Age: 18Years - 72Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged between 18 and 72 years residing in the southeast region of Norway
- Admitted to Oslo University Hospital directly or transferred from local hospitals within 72 hours after injury
- Hospital stay of at least two days
- Traumatic injury with a New Injury Severity Scale score greater than 9
- Reporting injury-related symptoms, functional impairments, or difficulties with daily activities at hospital discharge
You will not qualify if you...
- Mini Mental Status score below 20 points indicating cognitive impairment
- Psychiatric diseases requiring treatment
- Drug or alcohol dependence requiring treatment
- Complete spinal cord injury or isolated thoracic or abdominal injury
- Insufficient command of the Norwegian language
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Baseline Assessment
Duration - 1 day
Participants complete baseline assessments including interviews and patient-reported outcome measures before starting the intervention or control condition.
1 visit (in-person or remote)
Outpatient Treatment
Duration - 8 weeks
Participants assigned to the intervention attend the self-management support program consisting of weekly 2.5-hour group sessions over eight weeks. Those in the control group receive usual health and rehabilitation services provided in their community.
Weekly visits for up to 8 weeks
Follow-up Assessments
Duration - 6 months
Participants complete follow-up assessments after the intervention period and at 3 and 6 months post-intervention to evaluate outcomes such as self-efficacy, symptom burden, and functioning.
3 visits (in-person or remote) over 6 months
Trial Site Locations
Total: 1 location
1
Oslo University Hospital
Oslo, Norway
Actively Recruiting
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Research Team
N
Nada Andelic, PhD
M
Mari Storli Rasmussen, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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