Ignite Creation Date:
2024-07-17 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06466499
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-06-06
Brief Title:
Non-pharmacological Treatment of Patients at Risk of Developing Persistent Posttraumatic Headache
Sponsor:
Hospital of South West Jutland
Organization:
Hospital of South West Jutland
Study Overview
Official Title:
Non-pharmacological Treatment of Patients at Risk of Developing Persistent Posttraumatic Headache
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
None
Brief Summary:
The goal of this mixed method study is to test and evaluate the effect of an early interdisciplinary non-pharmacological treatment of patients at risk of developing persistent posttraumatic headache in order to prevent the development of persistent posttraumatic headache and thereby reduce persistency and improve the quality of life Furthermore to gain knowledge on and a deeper understanding of the patients perspective and experience of the treatment
The project consists of 3 sub studies
1 A feasibility study with the purpose of exploring the feasibility of an early non-pharmacological intervention for patients with persistent posttraumatic headache after mild traumatic brain injury
2 An experimental design a randomized controlled trial to evaluate the effect of the early non-pharmacological treatment
3 A qualitative focus group interview study to get a more nuanced knowledge of patients experience with the non-pharmacological treatment related to post traumatic headache
The project consists of 3 sub studies
1 A feasibility study with the purpose of exploring the feasibility of an early non-pharmacological intervention for patients with persistent posttraumatic headache after mild traumatic brain injury
2 An experimental design a randomized controlled trial to evaluate the effect of the early non-pharmacological treatment
3 A qualitative focus group interview study to get a more nuanced knowledge of patients experience with the non-pharmacological treatment related to post traumatic headache
Detailed Description:
The feasibility study will be performed prior to a randomized controlled trial and aim to assess the following recruitment capability data collection procedures and outcome measures acceptability of the intervention resources and ability to manage the study and intervention and participant responses to the intervention
Study population and recruitment The project will be conducted at the University Hospital of Southern Denmark Patients will be recruited from the Emergency department All patients hospitalized with mild traumatic brain injury mTBI will be asked to sign a statement of consent so the researcher is allowed to contact the patients for eligibility after three months Participation in the study is voluntary Patients will be informed about the feasibility nature of the study and included after oral consent A neurological exam will be performed to assess final eligibility
Patients are included 3-5 months after trauma and the intervention is initiated no later than six months after mTBI In this study a sample size of 8 participants are chosen to assess feasibility
Intervention The intervention will take place at the specialized Headache Clinic at the University Hospital of Southern Denmark It will cover an interdisciplinary 5-week program with sessions from both psychologists and physiotherapists all working at the Headache Clinic The psychologist sessions will focus on topics regarding cognitive behavioural therapy psychoeducation occupational rehabilitation and work activity The physiotherapeutic sessions will include a combination of exercises on neck tensions relaxation therapies and advises on how to return gradually to daily activities social cognitive and physical activities such as reading working by the computer house cleaning exercising and going out with friends Furthermore patients will get exercise handouts to do at home between sessions Both psychologist and physiotherapist sessions will be group-based with 6-8 patients in each group Once every week the groups receive psychologist sessions lasting 90 minutes and afterwards physiotherapist sessions of 60 minutes
The aim of the randomized controlled trial RCT is to investigate the effect of an early non-pharmacological treatment in patients at risk of developing persistent PTH The null-hypothesis is that there is no difference between the groups however the alternative hypothesis is that the intervention will result in reduced number of individuals with persistent headache 6 months after the trauma
The overall preliminary set-up of the RCT study will be as in the feasibility study Therefore recruitment study population measurements intervention and standard treatment are as described above The RCT measurements will be conducted three times baseline post intervention and at six months follow-up
The primary outcome is number of days with headache within the last week There is no available reference of clinical trials regarding the group by time effect of non-pharmacological treatment on patients with persistent posttraumatic headache PTH In order to establish the premise for the sample size calculation we therefore used results from studies on similar headache groups together with empirical clinical assumption A study has shown that patients with persistent PTH of a moderate or severe intensity have an average of approximately 20 days per month and we assume that approximately 20 reduction is clinically relevant To detect at minimal clinically important difference MICD of 35 days standard deviation SD 80 per month between the groups on two-sided significance level of 005 and power of 80 it is required to enrol 83 patients in the intention to treat ITT population We will include 52 participants in each group to account for dropouts
Randomization will be performed after baseline measurements are collected using the web-based service Sealed envelope Patients will be randomized 11 to receive either 5 weeks of interventional program or standard treatment Block randomization block sizes of 2 4 and 6 are used and the principal researcher will be blinded to allocation
Statistics Between group effects of the interventional program is assessed by mixed-effects models for repeated measurement with a time factor for baseline five weeks and six months The models residuals are tested for normal distribution and before conducting analyses the variance homogeneity and assumption of linearity is investigated To accommodate minor deviations from normally distributed data robust estimation function will be applied Analyses on the effects of the intervention is conducted according to the ITT principle including all randomized patients irrespectively of withdrawal or drop-out Subsequently per protocol PP analyses is performed including those patients from the intervention group who is compliant attended 50 of the interventional sessions compared with the patients from the control group Missing data will be handled by multiple imputations assuming that data is missing at random Ten imputations are chosen as suitable For hypothesis testing two-tailed tests is used and the significance level is 005 for all tests
The qualitative focus group interview study will be conducted to gain knowledge of what it means to patients with PTH to participate in an early non-pharmacological intervention with respect to perceived quality of life and self-management in daily activities after a head trauma
Study participants and setting The participating patients are the same patients who attend the interventional program in the RCT study Participants are at baseline asked if they will participate in an interview after the intervention Participants who agrees to the interview and signs an informed consent will be invited for focus group interviews with health care professionals when intervention is complete The researcher will through data saturation claim when enough participants have been interviewed to achieve research purpose Data saturation refers to the point in the research process when no new information is discovered during the interviews This redundancy signals to the researcher that interviews and thereby data collection may cease There will be four focus group interviews conducted Each focus group consists of five to six patients All interviews will be performed at the University Hospital of Southern Denmark after the 5-weeks intervention and the duration of the interviews are approximately 90 minutes
Data collection The principal researcher and a researcher assistant will be facilitating the interviews as this set-up provides capability for one to interact in the group conversations while the other one notes interesting non-verbal interaction in the groups A semi-structured interview guide will be developed prior to conducting the focus group interviews Overall themes for the interview guide are Thoughts about the intervention and how it affects their everyday life illness mastery changes in the general well-being after the intervention changes in coping strategies self-management thoughts and feelings about the future
Data analysis and interpretation The interviews will be audio recorded verbatim transcribed and anonymized with pseudonyms by the principal investigator Interview data are systematically entered into a qualitative data analyses software program for coding The theoretical approach will be phenomenological-hermeneutic inspired by Paul Ricoeurs theory of narratives and interpretation A three-phased interpretation process will be used naïve reading which provides an initial overall impression of the data structural analysis where the data are structured by units of meaning and units of significance providing themes and critical interpretation and discussion where the findings are interpreted and discussed with theory and research knowledge This approach will allow the movement from individual perspective to a more general interpretation
Study population and recruitment The project will be conducted at the University Hospital of Southern Denmark Patients will be recruited from the Emergency department All patients hospitalized with mild traumatic brain injury mTBI will be asked to sign a statement of consent so the researcher is allowed to contact the patients for eligibility after three months Participation in the study is voluntary Patients will be informed about the feasibility nature of the study and included after oral consent A neurological exam will be performed to assess final eligibility
Patients are included 3-5 months after trauma and the intervention is initiated no later than six months after mTBI In this study a sample size of 8 participants are chosen to assess feasibility
Intervention The intervention will take place at the specialized Headache Clinic at the University Hospital of Southern Denmark It will cover an interdisciplinary 5-week program with sessions from both psychologists and physiotherapists all working at the Headache Clinic The psychologist sessions will focus on topics regarding cognitive behavioural therapy psychoeducation occupational rehabilitation and work activity The physiotherapeutic sessions will include a combination of exercises on neck tensions relaxation therapies and advises on how to return gradually to daily activities social cognitive and physical activities such as reading working by the computer house cleaning exercising and going out with friends Furthermore patients will get exercise handouts to do at home between sessions Both psychologist and physiotherapist sessions will be group-based with 6-8 patients in each group Once every week the groups receive psychologist sessions lasting 90 minutes and afterwards physiotherapist sessions of 60 minutes
The aim of the randomized controlled trial RCT is to investigate the effect of an early non-pharmacological treatment in patients at risk of developing persistent PTH The null-hypothesis is that there is no difference between the groups however the alternative hypothesis is that the intervention will result in reduced number of individuals with persistent headache 6 months after the trauma
The overall preliminary set-up of the RCT study will be as in the feasibility study Therefore recruitment study population measurements intervention and standard treatment are as described above The RCT measurements will be conducted three times baseline post intervention and at six months follow-up
The primary outcome is number of days with headache within the last week There is no available reference of clinical trials regarding the group by time effect of non-pharmacological treatment on patients with persistent posttraumatic headache PTH In order to establish the premise for the sample size calculation we therefore used results from studies on similar headache groups together with empirical clinical assumption A study has shown that patients with persistent PTH of a moderate or severe intensity have an average of approximately 20 days per month and we assume that approximately 20 reduction is clinically relevant To detect at minimal clinically important difference MICD of 35 days standard deviation SD 80 per month between the groups on two-sided significance level of 005 and power of 80 it is required to enrol 83 patients in the intention to treat ITT population We will include 52 participants in each group to account for dropouts
Randomization will be performed after baseline measurements are collected using the web-based service Sealed envelope Patients will be randomized 11 to receive either 5 weeks of interventional program or standard treatment Block randomization block sizes of 2 4 and 6 are used and the principal researcher will be blinded to allocation
Statistics Between group effects of the interventional program is assessed by mixed-effects models for repeated measurement with a time factor for baseline five weeks and six months The models residuals are tested for normal distribution and before conducting analyses the variance homogeneity and assumption of linearity is investigated To accommodate minor deviations from normally distributed data robust estimation function will be applied Analyses on the effects of the intervention is conducted according to the ITT principle including all randomized patients irrespectively of withdrawal or drop-out Subsequently per protocol PP analyses is performed including those patients from the intervention group who is compliant attended 50 of the interventional sessions compared with the patients from the control group Missing data will be handled by multiple imputations assuming that data is missing at random Ten imputations are chosen as suitable For hypothesis testing two-tailed tests is used and the significance level is 005 for all tests
The qualitative focus group interview study will be conducted to gain knowledge of what it means to patients with PTH to participate in an early non-pharmacological intervention with respect to perceived quality of life and self-management in daily activities after a head trauma
Study participants and setting The participating patients are the same patients who attend the interventional program in the RCT study Participants are at baseline asked if they will participate in an interview after the intervention Participants who agrees to the interview and signs an informed consent will be invited for focus group interviews with health care professionals when intervention is complete The researcher will through data saturation claim when enough participants have been interviewed to achieve research purpose Data saturation refers to the point in the research process when no new information is discovered during the interviews This redundancy signals to the researcher that interviews and thereby data collection may cease There will be four focus group interviews conducted Each focus group consists of five to six patients All interviews will be performed at the University Hospital of Southern Denmark after the 5-weeks intervention and the duration of the interviews are approximately 90 minutes
Data collection The principal researcher and a researcher assistant will be facilitating the interviews as this set-up provides capability for one to interact in the group conversations while the other one notes interesting non-verbal interaction in the groups A semi-structured interview guide will be developed prior to conducting the focus group interviews Overall themes for the interview guide are Thoughts about the intervention and how it affects their everyday life illness mastery changes in the general well-being after the intervention changes in coping strategies self-management thoughts and feelings about the future
Data analysis and interpretation The interviews will be audio recorded verbatim transcribed and anonymized with pseudonyms by the principal investigator Interview data are systematically entered into a qualitative data analyses software program for coding The theoretical approach will be phenomenological-hermeneutic inspired by Paul Ricoeurs theory of narratives and interpretation A three-phased interpretation process will be used naïve reading which provides an initial overall impression of the data structural analysis where the data are structured by units of meaning and units of significance providing themes and critical interpretation and discussion where the findings are interpreted and discussed with theory and research knowledge This approach will allow the movement from individual perspective to a more general interpretation
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