An interventional study of self-management support program and Control group in Trauma Injury, Trauma, Multiple and Polytrauma, sponsored by Oslo University Hospital. Recruiting at 1 site in Norway. Open to participants aged 18 Years to 72 Years. Per ClinicalTrials.gov, last updated 2024-04-12.
Sponsored by Oslo University Hospital · Not applicable, Interventional, and Health services research
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.
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:
Patients will be excluded in case of:
Patients who consent to participate will be randomised into a randomisation arm (RA) or a self-selection arm (SA). Participants in the RA will then be further randomised to intervention or control group. In the self-selection arm, the participants can choose whether they will be placed in the intervention or control group. The self-selection arm is an explorative part of the study to explore if taking into account patient treatment preferences may maximise adherence, reduce potential attrition bias and influence the intervention results. Data will be collected through interview/patient-reported outcome measures (PROMs) at the following time points: baseline assessment (T1), after completion of the intervention (T2), 3-months after completion of the intervention (T3), and 6-months after the intervention (T4), with similar time-points for those in the control group.
The primary outcome is self-efficacy assessed with the Trauma Coping Self-Efficacy Scale. Secondary outcomes include symptom burden, physical, cognitive and emotional functioning. Additional outcomes include resilience, health-related quality of life, communication with health professionals, health literacy, global functioning and disability, and evaluation of changes. The participants will complete all outcome measures. In addition, participants will nominate their target problem areas with their own words and will be asked to select one personal outcome preference from the predefined outcomes.
Sample size calculation and statistical analyses:
Sample size was estimated based on the primary outcome. Results from a study on mental eHealth interventions following trauma were used. A power calculation was conducted with a standard deviation of 1.0 and a mean group difference of 0.6. Given an 80% power and an alpha of 0.05, 90 participants should be included to observe significant treatment related improvement. With an assumed attrition rate of 20%, 110 participants will be included (i.e. 55 participants in each group). The sample size calculation was done based on the randomization arm (RA), and we aim to achieve the same power in the self-selection (SA) arm. However, the SA is considered an exploratory part of this study to evaluate the influence of patients' treatment preferences.
To investigate the effectiveness of the intervention on self-efficacy, symptom burden and disability, and patient-impression of change, mixed-effect models will be used to account for repeated measurements by patients. Time and time-by-treatment interaction will be used as fixed effects in these models. The linear mixed model will give estimated mean values for all time points (T1, T2, T3, and T4), changes from baseline, and between -group differences from baseline with 95% confidence intervals. The analyses will be based on an "intention to treat" principle. In addition, clinical benefit will be estimated in quality-adjusted life years (QALYs) using standardized conversion tools to convert health benefits into an index of HRQL, as measured by EQ-5D. Simulated cost consequences of the program will be considered from health and societal perspectives.
128 studies on the registry are indexed under Accidental Injuries; 39 are open to participants now.
This study's planned enrollment of 220 is above the median of 110 across 67 interventional studies indexed under Accidental Injuries.
Browse Accidental Injuries studies →Oslo University Hospital is the lead sponsor of 834 studies on the registry; 149 are open to participants now.
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Exclusion Criteria:
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
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
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
Treatment as usual
Also known as: Control
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: 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
Self-reported change in post-concussion symptoms measured on a 16-item questionnaire, with Likert scale from 0 (no symptoms) to 4 (severe symptom)
Time frame: 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
Self-reported change in fatigue symptoms measured on a 9-item questionnaire, with a Likert scale from 1 (Totally disagree) to 7 (totally agree).
Time frame: 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
Self-reported change in sleep disturbance measured on a 5-item questionnaire, with Likert scale from 1-5.
Time frame: 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
Self-reported change in pain measured on a 9-item questionnaire, with Likert scale from 0 -10.
Time frame: 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
Self-reported frequency of physical activity and specific levels of intensity.
Time frame: 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
Self-reported change in cognitive failures measured on a 25-item questionnaire, with Likert scale from 0 (never) to 4 (very often).
Time frame: 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
Self-reported change in depressive symptoms measured on a 9-item questionnaire, with Likert scale from 0 (not at all) to 3 (nearly every day).
Time frame: 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
Self-reported change in anxiety symptoms measured on a 7-item questionnaire, with Likert scale from 0 (not at all) to 3 (nearly every day).
Time frame: 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
Self-reported change in post-traumatic stress symptoms measured on a 22-item questionnaire, with Likert scale from 0 (not at all) to 4 (extremely).
Time frame: 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
Self-report of full-time/part-time job (percentage); hours per week
Time frame: Change from baseline (T1) to immediately after the intervention period (T2), 3 months after intervention (T3), and 6 months after intervention (T4)
Resilience Scale for Adults
Self-reported change in post-traumatic stress symptoms measured on a 33-item questionnaire, with Likert scale from 0 to 4.
Time frame: 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
Self-reported change in health-related quality of life measured on a 5-item questionnaire, with Likert scale from 1 to 5.
Time frame: Change from baseline (T1) to immediately after the intervention period (T2), 3 months after intervention (T3), and 6 months after intervention (T4)
Target Outcomes
Self-nominated 3 most troublesome difficulties related to trauma injury. Problem area rated how difficult it is to manage the problem on a five-point Likert scale from 0 (not at all difficult) to 4 (extremely difficult).
Time frame: Change from baseline (T1) to immediately after the intervention period (T2), 3 months after intervention (T3), and 6 months after intervention (T4)
Patient Global Impression of Change
One- item questionnaire measuring self-evaluation in global change of functioning, on a Likert scale from 1 (no change) to 7 (a great deal better).
Time frame: Change immediately after the intervention period (T2), 3 months after intervention (T3), and 6 months after intervention (T4)
Intervention acceptability and satisfaction
Intervention group only. 8-item questionnaire measuring level of satisfaction and program usefulness on a Likert scale from 1 (not useful) to 5 (extremely useful).
Time frame: Measured immediately after the intervention period (T2).
Intervention satisfaction
Intervention group only. Open-ended questionnaire inquiring satisfaction with intervention.
Time frame: Measured immediately after the intervention period (T2).
WHO Disability Assessment Scale
12-item questionnaire measuring health and disability on a Likert scale from 1 (no difficulty) to 5 (extremely difficult).
Time frame: Change from baseline (T1) to immediately after the intervention period (T2), 3 months after intervention (T3), and 6 months after intervention (T4)
Glasgow Outcome Scale - Extended
The GOS-E is an ordinal scale measuring global functioning outcome: (1) Death, (2) Vegetative State, (3) Lower Severe Disability, (4) Upper Severe Disability, (5) Lower Moderate Disability, (6) Upper Moderate Disability, (7) Lower Good Recovery, and (8) Upper Good Recovery.
Time frame: Change from baseline (T1) to immediately after the intervention period (T2), 3 months after intervention (T3), and 6 months after intervention (T4)
Communication with physicians
3-item questionnaire measuring degree of coping in communication with health care providers, measured on a Likert scale from 0 (never) to 5 (always)
Time frame: Change from baseline (T1) to immediately after the intervention period (T2), 3 months after intervention (T3), and 6 months after intervention (T4)
Health Literacy Questionnaire
3-item questionnaire measuring level of health literacy, measured on a Likert scale from 1 (always a problem) to 5 (never)
Time frame: Change from baseline (T1) to immediately after the intervention period (T2), 3 months after intervention (T3), and 6 months after intervention (T4)
Received health care services
Type and frequency of health care services received
Time frame: Change from baseline (T1) to immediately after the intervention period (T2), 3 months after intervention (T3), and 6 months after intervention (T4)
Plan to share: No — Only aggregated data will be shared according to the Norwegian legislation
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Started Jan 2024 (actual). Primary completion is estimated for Dec 2030, 83 months after the start.
Of 34 non-industry interventional studies with no phase under Accidental Injuries, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 51. This study's planned 83 months is above that.
Counting every sponsor, half of 35 studies reached it within 23 months; a quarter within 7 and three quarters within 41.
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