Ignite Creation Date:
2024-05-06 @ 1:48 PM
Last Modification Date:
2024-10-26 @ 1:20 PM
Study NCT ID:
NCT04138524
Status:
TERMINATED
Last Update Posted:
2022-07-20
First Post:
2019-10-05
Brief Title:
SAFIR An Early Intervention for Supporting Families of Patients With Acquired Brain Injuries
Sponsor:
Centre Hospitalier Universitaire Vaudois
Organization:
Centre Hospitalier Universitaire Vaudois
Study Overview
Official Title:
A Feasibility Study on the Newly Developed Early Intervention for Families of Patients With Acquired Brain Injuries SAFIR
Status:
TERMINATED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Pandemic of SARS-CoV2
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAFIR
Brief Summary:
The aim of the study is to evaluate the feasibility of a newly developed intervention to improve family support for patient with acquired brain injury ABI in early phase of hospitalization SAFIR the main components are the assessment of the family the emotional support for the families the information giving to the families the inclusion of the families in the care process and the care coordination between the inter professional team
The main outcomes of the study are feasibility and acceptability outcomes of the newly developed intervention and trend in efficacy in the family functioning coping and perceived support from the nurses
The main outcomes of the study are feasibility and acceptability outcomes of the newly developed intervention and trend in efficacy in the family functioning coping and perceived support from the nurses
Detailed Description:
The aim of the study is to determine the feasibility of a newly developed intervention called SAFIR to support families of Acquired Brain Injuries ABI patients from the early phase acute phase of hospitalization It will be conducted in the Department of Clinical Neurosciences DNC of Lausanne University Hospital According to the study design there will be no control group
The intervention process engages all stakeholders but is led by the trained clinical nurse specialist CNS of the care unit
Screening for recruitment by the head nurse or the CNS will start from day 1 of patients hospitalization at DNC The CNS will meet the screened patients and their family with the medical team This first contact will allow the CNS to introduce himherself to explain hisher role to give all relevant information and forms and to schedule a second appointment after 24 hours of reflection In particular heshe will explain to each participant the nature of the study its purpose the procedures involved the expected duration the potential risks and benefits and any discomfort it may entail Information and Consent Forms will be provided to patients when relevant or its Legal Representative as well as to potential participants among family members Each participant will be informed that the participation in the study is voluntary he or she may withdraw from the study at any time and withdrawal of consent without affecting the patients subsequent medical care and treatment A 24-hour reflection period for consent will be offered to the potential participants The consent form will be signed and dated by the investigator or his designee at the same time as the participant sign A copy of the signed informed consent will be given to the study participant An Independent physician consent form will also be signed by the medical doctor in charge of the patient The consent form will be retained as part of the study records as well as the Independent physician consent form The informed consent process will be documented in the research files and any discrepancy to the process described in the protocol will be explained if necessary Overall the study will be conducted in compliance with the protocol the current version of the Declaration of Helsinki
If participant agrees to take part in the study D0 the intervention will start The intervention is organized in three main phases at day 3 day 5 and day 10 with a follow-up at day 30 Each phase include a preparation with the inter professional team for family interview a structured family interview lead by CNS and a feed-back with the inter professional team Measures related to the ability to carry out the intervention acceptability and integration of the intervention to the nursing care the fidelity to the protocol the recruitment and the retention will be collected throughout the process At baseline data collection will include socio-demographics data on the participants Iceland-Expressive Family Functioning Questionnaire Iceland-Family Perceived Support Questionnaire and Brief-Cope Questionnaire measures These measures will be repeated at D10 and D30
Both Investigator and Sponsor-Investigator will make a severity assessment of all adverse events as mild moderate or severe Mild means the complication is tolerable moderate means it interferes with daily activities and severe means it renders daily activities impossible All serious adverse event SAE will be documented and reported immediately within a maximum of 24 hours to the Sponsor-Investigator of the study If it cannot be excluded that the SAE is attributable to the intervention under investigation the Investigator will report it to the Ethics Committee within 15 days
An annual safety report will be submitted to the local Ethics Committee by the Investigator
The amount and reasons for missing data would be gathered summarized and analyzed in order to understand which part of data collection is not feasible again
No imputation procedures will be applied to handle missing data due to design of the study As far as possible incomplete data will be included into analyses to avoid bias The methods that will be applied to the quantitative analyses can cope with incomplete data Data of those participants who are unwilling to continue the program once started will still be included the analysis in order to assess the feasibility and acceptability of the intervention Nevertheless if patient recover and can give hisher consent a posteriori it will be possible until the end of the study if the patient refuse to consent hisher data will not be used but all data of hisher family members that consent to participate will be kept and the intervention will go on for them
As it is a feasibility study no criteria for withdrawal will be applicable in the study except if participant would like to
Descriptive analyses will be performed The qualitative data will be analyzed using Maxqda software following a methodology for thematic analysis Comparisons of quantitative data between baseline D0 and after the intervention D10 and D30 will be assessed by means of generalized linear mixed regression models using STATA Release 15 Such models deal with the non-independence of data repeatedly measured on the same subjects and allow the use of incomplete data This model will also take into account the non-independence of family members within a family three level models time repeated within family members and family members clustered within family Time will be treated as the fixed part of the model whereas the families and family members will represent the random parts hence the name mixed model The effect of time will assessed by two regression coefficients representing the mean change in the dependent variables from D0 to D10 and from D0 to D30 A calculation of the size of effect of the intervention will be performed in order to measure the magnitude of the intervention A Cohen d will be calculated considering 05 as a moderate effect size Process factors variables will be analyzed using descriptive tests As it is a feasibility study no sample size calculation is required
Substantial changes to the study setup and study organization the protocol and relevant study documents will be submitted to the Ethics Committee for approval before implementation Under emergency circumstances deviations from the protocol to protect the rights safety and well-being of human subjects may proceed without prior approval of the Ethics Committee Such deviations shall be documented and reported to the Ethics Committee as soon as possible
The Sponsor-Investigator may terminate the study prematurely according to certain circumstances Upon regular study termination the Ethics Committee will be notified within 90 days
Upon premature study termination or study interruption the Ethics Committee will be notified within 15 days In the event of study-related damage or injuries the liability of the institution Institute for Higher Education and Healthcare provides compensation except for claims that arise from misconduct or gross negligence
The benefits from participating in the study have not been demonstrated however it is more likely that family members may benefit from having additional support Nevertheless it is not excluded that some family members may experience negative thoughts during the study the participants will therefore be informed they can get support other than the one provided if required This will be documented as it is an important information of this feasibility study
For quality assurance the sponsor the Ethics Committee or an independent trial monitor may visit the research sites Direct access to the source data and all study related files is granted on such occasions A trained trial monitoring person will verify collected data accuracy completeness and traceability All involved parties keep the participant data strictly confidential
Data will be coded following Swiss ethics recommendation year of birth 3 letters of code for code identification Original data of forms and questionnaires will be kept locked in a secure location specifically dedicated to study records Interviews will be recorded and protected by a password to which only the research team will have access to Data will be collected and recorded on REDCAP
Trial and participant data will be handled with uttermost discretion and is only accessible to authorized personnel who require the data to fulfill their duties within the scope of the study On the Case Report Forms CRF and other study specific documents participants are only identified by a unique participant number The co-investigator stores the participants identification list on a locked place as well as the numeric data will be protected by a password
All study data will be archived for 10 years after study termination or premature termination of the study All study data will be archived and locked
Data will be available for monitors and questions will be answered as well in any time Data monitoring will be conducted following the standard guideline This will guarantee the protection of the participants safety their rights integrity and confidentiality and data quality
The study will be registered in French in the Swiss National Clinical trial Portal SNCTP via BASEC in addition of being registered on Clinicaltrialgov No conflict of interest is declared
The intervention process engages all stakeholders but is led by the trained clinical nurse specialist CNS of the care unit
Screening for recruitment by the head nurse or the CNS will start from day 1 of patients hospitalization at DNC The CNS will meet the screened patients and their family with the medical team This first contact will allow the CNS to introduce himherself to explain hisher role to give all relevant information and forms and to schedule a second appointment after 24 hours of reflection In particular heshe will explain to each participant the nature of the study its purpose the procedures involved the expected duration the potential risks and benefits and any discomfort it may entail Information and Consent Forms will be provided to patients when relevant or its Legal Representative as well as to potential participants among family members Each participant will be informed that the participation in the study is voluntary he or she may withdraw from the study at any time and withdrawal of consent without affecting the patients subsequent medical care and treatment A 24-hour reflection period for consent will be offered to the potential participants The consent form will be signed and dated by the investigator or his designee at the same time as the participant sign A copy of the signed informed consent will be given to the study participant An Independent physician consent form will also be signed by the medical doctor in charge of the patient The consent form will be retained as part of the study records as well as the Independent physician consent form The informed consent process will be documented in the research files and any discrepancy to the process described in the protocol will be explained if necessary Overall the study will be conducted in compliance with the protocol the current version of the Declaration of Helsinki
If participant agrees to take part in the study D0 the intervention will start The intervention is organized in three main phases at day 3 day 5 and day 10 with a follow-up at day 30 Each phase include a preparation with the inter professional team for family interview a structured family interview lead by CNS and a feed-back with the inter professional team Measures related to the ability to carry out the intervention acceptability and integration of the intervention to the nursing care the fidelity to the protocol the recruitment and the retention will be collected throughout the process At baseline data collection will include socio-demographics data on the participants Iceland-Expressive Family Functioning Questionnaire Iceland-Family Perceived Support Questionnaire and Brief-Cope Questionnaire measures These measures will be repeated at D10 and D30
Both Investigator and Sponsor-Investigator will make a severity assessment of all adverse events as mild moderate or severe Mild means the complication is tolerable moderate means it interferes with daily activities and severe means it renders daily activities impossible All serious adverse event SAE will be documented and reported immediately within a maximum of 24 hours to the Sponsor-Investigator of the study If it cannot be excluded that the SAE is attributable to the intervention under investigation the Investigator will report it to the Ethics Committee within 15 days
An annual safety report will be submitted to the local Ethics Committee by the Investigator
The amount and reasons for missing data would be gathered summarized and analyzed in order to understand which part of data collection is not feasible again
No imputation procedures will be applied to handle missing data due to design of the study As far as possible incomplete data will be included into analyses to avoid bias The methods that will be applied to the quantitative analyses can cope with incomplete data Data of those participants who are unwilling to continue the program once started will still be included the analysis in order to assess the feasibility and acceptability of the intervention Nevertheless if patient recover and can give hisher consent a posteriori it will be possible until the end of the study if the patient refuse to consent hisher data will not be used but all data of hisher family members that consent to participate will be kept and the intervention will go on for them
As it is a feasibility study no criteria for withdrawal will be applicable in the study except if participant would like to
Descriptive analyses will be performed The qualitative data will be analyzed using Maxqda software following a methodology for thematic analysis Comparisons of quantitative data between baseline D0 and after the intervention D10 and D30 will be assessed by means of generalized linear mixed regression models using STATA Release 15 Such models deal with the non-independence of data repeatedly measured on the same subjects and allow the use of incomplete data This model will also take into account the non-independence of family members within a family three level models time repeated within family members and family members clustered within family Time will be treated as the fixed part of the model whereas the families and family members will represent the random parts hence the name mixed model The effect of time will assessed by two regression coefficients representing the mean change in the dependent variables from D0 to D10 and from D0 to D30 A calculation of the size of effect of the intervention will be performed in order to measure the magnitude of the intervention A Cohen d will be calculated considering 05 as a moderate effect size Process factors variables will be analyzed using descriptive tests As it is a feasibility study no sample size calculation is required
Substantial changes to the study setup and study organization the protocol and relevant study documents will be submitted to the Ethics Committee for approval before implementation Under emergency circumstances deviations from the protocol to protect the rights safety and well-being of human subjects may proceed without prior approval of the Ethics Committee Such deviations shall be documented and reported to the Ethics Committee as soon as possible
The Sponsor-Investigator may terminate the study prematurely according to certain circumstances Upon regular study termination the Ethics Committee will be notified within 90 days
Upon premature study termination or study interruption the Ethics Committee will be notified within 15 days In the event of study-related damage or injuries the liability of the institution Institute for Higher Education and Healthcare provides compensation except for claims that arise from misconduct or gross negligence
The benefits from participating in the study have not been demonstrated however it is more likely that family members may benefit from having additional support Nevertheless it is not excluded that some family members may experience negative thoughts during the study the participants will therefore be informed they can get support other than the one provided if required This will be documented as it is an important information of this feasibility study
For quality assurance the sponsor the Ethics Committee or an independent trial monitor may visit the research sites Direct access to the source data and all study related files is granted on such occasions A trained trial monitoring person will verify collected data accuracy completeness and traceability All involved parties keep the participant data strictly confidential
Data will be coded following Swiss ethics recommendation year of birth 3 letters of code for code identification Original data of forms and questionnaires will be kept locked in a secure location specifically dedicated to study records Interviews will be recorded and protected by a password to which only the research team will have access to Data will be collected and recorded on REDCAP
Trial and participant data will be handled with uttermost discretion and is only accessible to authorized personnel who require the data to fulfill their duties within the scope of the study On the Case Report Forms CRF and other study specific documents participants are only identified by a unique participant number The co-investigator stores the participants identification list on a locked place as well as the numeric data will be protected by a password
All study data will be archived for 10 years after study termination or premature termination of the study All study data will be archived and locked
Data will be available for monitors and questions will be answered as well in any time Data monitoring will be conducted following the standard guideline This will guarantee the protection of the participants safety their rights integrity and confidentiality and data quality
The study will be registered in French in the Swiss National Clinical trial Portal SNCTP via BASEC in addition of being registered on Clinicaltrialgov No conflict of interest is declared
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