Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06305819
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-03-05
Brief Title:
Effectiveness of a Self-management Program After Traumatic Injury
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Managing Symptoms and Disability in the Sub-acute Phase After Traumatic Injury - A Pragmatic Randomised Controlled Trial of a Self-management Support Program
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SEMPO
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 workstudies 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 ie 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
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 ie 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
Detailed Description:
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
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 andor difficulties with daily activities at the discharge from OUH According to preliminary analyses in ongoing study on unmet needs after trauma funded by South-Eastern Norway Regional Health Authority these patients are in risk of developing long-lasting disabilities
Patients will be excluded in case of
Cognitive function corresponding to a Mini Mental Status score MMS 20 points
Psychiatric diseases that require treatment
Drugalcohol dependence that require treatment
Complete spinal cord injury and isolated thoracic or abdominal injury
Insufficient command of Norwegian
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 interviewpatient-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 10 and a mean group difference of 06 Given an 80 power and an alpha of 005 90 participants should be included to observe significant treatment related improvement With an assumed attrition rate of 20 110 participants will be included ie 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
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
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 andor difficulties with daily activities at the discharge from OUH According to preliminary analyses in ongoing study on unmet needs after trauma funded by South-Eastern Norway Regional Health Authority these patients are in risk of developing long-lasting disabilities
Patients will be excluded in case of
Cognitive function corresponding to a Mini Mental Status score MMS 20 points
Psychiatric diseases that require treatment
Drugalcohol dependence that require treatment
Complete spinal cord injury and isolated thoracic or abdominal injury
Insufficient command of Norwegian
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 interviewpatient-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 10 and a mean group difference of 06 Given an 80 power and an alpha of 005 90 participants should be included to observe significant treatment related improvement With an assumed attrition rate of 20 110 participants will be included ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None