Ignite Creation Date:
2024-05-06 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03137420
Status:
UNKNOWN
Last Update Posted:
2018-10-31
First Post:
2017-04-28
Brief Title:
Psychological Distress in Relatives of Severely Injured Patients
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
Psychological Distress in Relatives of Severely Injured Patients
Status:
UNKNOWN
Status Verified Date:
2018-10
Last Known Status:
RECRUITING
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:
Patients who have sustained and survived a polytrauma do heavily depend on the support and functioning of their family This is only possible if the family members are physically and mentally able to cope with the situation
It is the investigators hypothesis that the true percentage of polytrauma patients relatives suffering under relevant psychological distress is higher than commonly assumed
The investigators conduct a prospective cohort study where we follow up on a cohort of patients and their relatives over 1 year after trauma - one group with severely injured patients case and one group with minor musculo-skeletal injuries control
In order to assess the influence of the patients disability and their own psychological distress on the psychological distress of the relatives the investigators also collect corresponding data from the patients themselves
In order to assess the influence of the trauma itself the investigators compare a group of multiple injured patients and their relatives with a group of patients with isolated musculoskeletal injuries and their relatives In addition the investigators record the ISS of each patient In order to investigate the changes in relatives distress over time and to find out more about potential risk factors or con-founders it is necessary to conduct a prospective study
It is the investigators hypothesis that the true percentage of polytrauma patients relatives suffering under relevant psychological distress is higher than commonly assumed
The investigators conduct a prospective cohort study where we follow up on a cohort of patients and their relatives over 1 year after trauma - one group with severely injured patients case and one group with minor musculo-skeletal injuries control
In order to assess the influence of the patients disability and their own psychological distress on the psychological distress of the relatives the investigators also collect corresponding data from the patients themselves
In order to assess the influence of the trauma itself the investigators compare a group of multiple injured patients and their relatives with a group of patients with isolated musculoskeletal injuries and their relatives In addition the investigators record the ISS of each patient In order to investigate the changes in relatives distress over time and to find out more about potential risk factors or con-founders it is necessary to conduct a prospective study
Detailed Description:
Background The incidence of polytrauma has been estimated to range between 25 and 52 per 100000 in Europe Severely injured patients are known to suffer increased psychological distress and early identification of these patients can help to provide resources and support for coping strategies The long-term physical and mental health of such polytrauma survivors can be improved by the presence of a supporting network including patients support groups social support networking and - most important - family and friends
While it has been shown that caring for a family member with chronic disease like cancer or disability after isolated traumatic brain injury or a stroke is associated with significant distress for relatives little is known on how families function and cope after one of them has had an accident with multiple severe injuries
Rationale for the research project Patients who have sustained and survived a polytrauma do heavily depend on the support and functioning of their family This is only possible if the family members are physically and mentally able to cope with the situation
It is the studys hypothesis that the true percentage of polytrauma patients relatives suffering under relevant psychological distress is higher than commonly assumed It is the investigators strong opinion that it would be important to identify these individuals early eg by a screening test as the one developed in this study in order to help the helpers
Objectives
Primary objective to investigate the psychological impact on relatives of having a severely injured patient as family member in dependence of
the patients disability and psychological stress
the severity of the trauma multiple injuries vs isolated musculoskeletal injury Secondary objective to develop a simple screening test Numeric Scale of Distress and to validate it against existing more complex scoring systems
Primary and secondary endpointoutcomes Primary outcome Hospital Anxiety and Depression Scale HADS at 1 3 6 and 12 months Secondary outcomes Brief Family Distress Scale BFDS and Numeric Scale of Family Distress NSFD at 1 3 6 and 12 months c Screening test Correlation between NSFD and HADS and NSFD and BFDS
Other study variables
Patients age and gender
Patients pattern of injury Abbreviated Injury Scale AIS Injury Severity Score ISS
Patients injury result of interperson-violence YesNo
Patients degree of disability Stanford HAQ 8-Item Disability Scale HAQDS
Patients situation of living home no help home with support nursing home
Relatives age and gender
Relatives degree of kinship spousepartner sondaughter parent sibling cousin
Design Prospective study In order to confirm the investigatorss primary hypothesis that the true percentage of polytrauma patients relatives suffering under relevant psychological distress is higher than commonly assumed we follow up on a cohort of patients and their relatives over 1 year after trauma - one group with severely injured patients case and one group with minor musculo-skeletal injuries control
In order to assess the influence of the patients disability and their own psychological distress on the psychological distress of the relatives the investigators also collect corresponding data from the patients themselves
In order to assess the influence of the trauma itself the investigators compare a group of multiple injured patients and their relatives with a group of patients with isolated musculoskeletal injuries and their relatives In addition the investigators record the ISS of each patient In order to investigate the changes in relatives distress over time and to find out more about potential risk factors or confounders it is necessary to conduct a prospective study
Procedures
1 a list of severely injured patients and patients with isolated non-life threatening musculo-skeletal injuries will be generated from the intern Polytrauma Database and the clinical information system Only those individuals will have access to this data that had already been involved into the treatment of these patients or otherwise had by law the right to access the charts in order not to violate the command of professional confidentiality
2 within 6 weeks of the initial trauma patients and their relatives who are eligible according to the inclusion and exclusion criteria will be contacted by phone and will be asked if they would be willing to participate duration for each participant 5 min in most cases only the patient or one member of the family will be contacted as a first representative During this phone call also the basic ability to understand German language will be assessed
3 if agreed the patient and their relatives will be send the study information the informed consent form and a short questionnaire containing the HADS 14 items the BFDS 1 item and the NSFD 1 numeric scaleas well as questions regarding the other variables listed above under 43 The questionnaires will be number-coded The patient will be asked to complete the HAQDS 8 items in addition Completion of the whole questionnaire will take about 10 min per participant The participants will be asked to send back the signed informed consent and the completed questionnaire
4 if there is no response to step 2 or 3 the participants will be contacted by phone or mail once more
5 the returned questionnaires will be evaluated for presence of informed consent and then transferred into a number-coded REDCap data file Only the research team will have access to the main data file and only the project leader will have access to the code key Both files will be stored on a research server of the Klinik für Traumatologie UniversitätsSpital Zürich
Criteria for withdrawal discontinuation of participants
A participant will be discontinued from the project in case of
withdrawal of informed consent
non-compliance In such case all health-related data that has already been acquired will be anonymized upon termination of data analysis or - if anonymization is not possible - will be kept for further analysis as the patient was informed and gave consent to at the beginning of the project
While it has been shown that caring for a family member with chronic disease like cancer or disability after isolated traumatic brain injury or a stroke is associated with significant distress for relatives little is known on how families function and cope after one of them has had an accident with multiple severe injuries
Rationale for the research project Patients who have sustained and survived a polytrauma do heavily depend on the support and functioning of their family This is only possible if the family members are physically and mentally able to cope with the situation
It is the studys hypothesis that the true percentage of polytrauma patients relatives suffering under relevant psychological distress is higher than commonly assumed It is the investigators strong opinion that it would be important to identify these individuals early eg by a screening test as the one developed in this study in order to help the helpers
Objectives
Primary objective to investigate the psychological impact on relatives of having a severely injured patient as family member in dependence of
the patients disability and psychological stress
the severity of the trauma multiple injuries vs isolated musculoskeletal injury Secondary objective to develop a simple screening test Numeric Scale of Distress and to validate it against existing more complex scoring systems
Primary and secondary endpointoutcomes Primary outcome Hospital Anxiety and Depression Scale HADS at 1 3 6 and 12 months Secondary outcomes Brief Family Distress Scale BFDS and Numeric Scale of Family Distress NSFD at 1 3 6 and 12 months c Screening test Correlation between NSFD and HADS and NSFD and BFDS
Other study variables
Patients age and gender
Patients pattern of injury Abbreviated Injury Scale AIS Injury Severity Score ISS
Patients injury result of interperson-violence YesNo
Patients degree of disability Stanford HAQ 8-Item Disability Scale HAQDS
Patients situation of living home no help home with support nursing home
Relatives age and gender
Relatives degree of kinship spousepartner sondaughter parent sibling cousin
Design Prospective study In order to confirm the investigatorss primary hypothesis that the true percentage of polytrauma patients relatives suffering under relevant psychological distress is higher than commonly assumed we follow up on a cohort of patients and their relatives over 1 year after trauma - one group with severely injured patients case and one group with minor musculo-skeletal injuries control
In order to assess the influence of the patients disability and their own psychological distress on the psychological distress of the relatives the investigators also collect corresponding data from the patients themselves
In order to assess the influence of the trauma itself the investigators compare a group of multiple injured patients and their relatives with a group of patients with isolated musculoskeletal injuries and their relatives In addition the investigators record the ISS of each patient In order to investigate the changes in relatives distress over time and to find out more about potential risk factors or confounders it is necessary to conduct a prospective study
Procedures
1 a list of severely injured patients and patients with isolated non-life threatening musculo-skeletal injuries will be generated from the intern Polytrauma Database and the clinical information system Only those individuals will have access to this data that had already been involved into the treatment of these patients or otherwise had by law the right to access the charts in order not to violate the command of professional confidentiality
2 within 6 weeks of the initial trauma patients and their relatives who are eligible according to the inclusion and exclusion criteria will be contacted by phone and will be asked if they would be willing to participate duration for each participant 5 min in most cases only the patient or one member of the family will be contacted as a first representative During this phone call also the basic ability to understand German language will be assessed
3 if agreed the patient and their relatives will be send the study information the informed consent form and a short questionnaire containing the HADS 14 items the BFDS 1 item and the NSFD 1 numeric scaleas well as questions regarding the other variables listed above under 43 The questionnaires will be number-coded The patient will be asked to complete the HAQDS 8 items in addition Completion of the whole questionnaire will take about 10 min per participant The participants will be asked to send back the signed informed consent and the completed questionnaire
4 if there is no response to step 2 or 3 the participants will be contacted by phone or mail once more
5 the returned questionnaires will be evaluated for presence of informed consent and then transferred into a number-coded REDCap data file Only the research team will have access to the main data file and only the project leader will have access to the code key Both files will be stored on a research server of the Klinik für Traumatologie UniversitätsSpital Zürich
Criteria for withdrawal discontinuation of participants
A participant will be discontinued from the project in case of
withdrawal of informed consent
non-compliance In such case all health-related data that has already been acquired will be anonymized upon termination of data analysis or - if anonymization is not possible - will be kept for further analysis as the patient was informed and gave consent to at the beginning of the project
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