Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06310434
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-03-07
Brief Title:
Analysis of COMPASsion and Humanisation of Adolescents Facing the End-of-life Processes
Sponsor:
Instituto de Salud Carlos III
Organization:
Instituto de Salud Carlos III
Study Overview
Official Title:
Analysis of COMPASsion and Humanisation of Adolescents Facing the End-of-life Processes a Mixed-method Participatory Project
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
COMPAS
Brief Summary:
The investigators want to work on compassion understood as the recognition of the suffering of others that motivates us to try to alleviate it The goal of this Multicenter project with a mixed sequential transformative methodology is to analyze the impact of a participatory process of awareness and reflection on compassion in the face of end-of-life processes in adolescents aged 12-23 years in 6 Spanish provinces and to understand how the participatory process can transform and improve their compassion
As the adolescents must be the protagonists of change the study will be conducted with students enrolled in one public secondary school and in one degree in a public University that belongs to the same health area in each province The investigators also include families and teachers knowledge of the context because it can support the interventions of change proposals
Compassion will be assessed using the Compassion for the Lives of Others Scale COOLS comprising 26 items Similarly adolescents attitudes toward death are another important concept and will be explored through the Death Anxiety Scale DAS which has 15 questions Both scales will be distributed to the adolescents requesting their permission anonymously
After the survey a second phase will start with a Participatory Action Research PAR with different activities The objective is to generate awareness of the need to improve it allowing the participants to design the interventions based on evidence-based proposals cinema forum colloquiums with testimonies of volunteers accompanying palliative patients organization of Death Cafe artistic and literary activities generation of grief groups etc
At the end of the project the investigators will evaluate the adolescent compassion level and create discussion groups again to understand the impact of the interventions
With this project the investigators will empower new generations of people to encourage facilitate support and celebrate mutual care and family and community development in end-of-life processes The translation and implications of the results for clinical practice will contribute to reducing inequalities in health research in a vulnerable group of special interest especially when treatments can do nothing for their survival but with interventions such as those in this study the investigators can ensure quality and dignity of life as long as there is life
As the adolescents must be the protagonists of change the study will be conducted with students enrolled in one public secondary school and in one degree in a public University that belongs to the same health area in each province The investigators also include families and teachers knowledge of the context because it can support the interventions of change proposals
Compassion will be assessed using the Compassion for the Lives of Others Scale COOLS comprising 26 items Similarly adolescents attitudes toward death are another important concept and will be explored through the Death Anxiety Scale DAS which has 15 questions Both scales will be distributed to the adolescents requesting their permission anonymously
After the survey a second phase will start with a Participatory Action Research PAR with different activities The objective is to generate awareness of the need to improve it allowing the participants to design the interventions based on evidence-based proposals cinema forum colloquiums with testimonies of volunteers accompanying palliative patients organization of Death Cafe artistic and literary activities generation of grief groups etc
At the end of the project the investigators will evaluate the adolescent compassion level and create discussion groups again to understand the impact of the interventions
With this project the investigators will empower new generations of people to encourage facilitate support and celebrate mutual care and family and community development in end-of-life processes The translation and implications of the results for clinical practice will contribute to reducing inequalities in health research in a vulnerable group of special interest especially when treatments can do nothing for their survival but with interventions such as those in this study the investigators can ensure quality and dignity of life as long as there is life
Detailed Description:
A multicenter project is proposed and designed as a mixed methods transformative sequential study in two phases
PHASE 1 Diagnosis of the situation of compassion through a descriptive observational study that will provide valuable information about understanding compassionate awareness in adolescents and will be useful for rigorously evaluating changes post-intervention in specific groups
To analyze the level of compassion of adolescents in every province the investigators include all the public secondary schools and a public university that belong to the same health area with similar population characteristics in each province In the 6 participating Universities there are 340 degrees and a total of 92103 students enrolled In the 6 Health Areas of the study provinces there are 61 high schools and the population of adolescents enrolled in school is 36486 Thus a random sample of 1852 individuals is enough to estimate with 95 confidence and a precision of - 010 units the population means values that are expected to have a standard deviation of about 156 units
A series of sociodemographic and educational variables will be collected from all participants to describe their characteristics such as age gender level of studies school educational context previous experience with dying people volunteer activities or other personal experience in palliative care PC Compassion will be assessed using the COOLS and adolescents attitudes toward death which will be explored through the DAS The evaluation scales will be distributed to the adolescents requesting their permission to distribute the questionnaires anonymously through the different specific communication channels that each educational center secondary school and university uses to keep up communication with the students The responses will be recorded online in the Research Electronic Data Capture REDCap an electronic data capture software
The investigators will elaborate a descriptive summary document on the level of adolescent compassion in all provinces taking into account variables such as educational context context compassion resources age and gender The investigators will analyze the differential characteristics of sex in compassion from a gender perspective In general the investigators will make descriptive statistics according to the nature of the variables with 95 confidence intervals
PHASE 2 related to the compassion transformation process To understand how the process of sensitization and participatory reflection is capable of transforming compassion the investigators design a PAR study based on the proposal of Stephen Kemmis and Robin McTaggart who suggest a PAR that focuses on the collective change that is produced from the individual reflections of the participants in a social context The research process will be participatory and cooperative to propose and promote effective changes from the participants and their context The project is designed in a sequence of cycles to design interventions implementation and evaluation
Before the activities a literature review will be done by the investigators to identify effective interventions to improve compassionate awareness in adolescents used by other researchers Next the investigators will design a plan of compassionate good practices in a participatory manner through discussion groups with students in secondary schools and universities separately In secondary school the investigators also will do groups with families and teachers separately because they can contribute to adapting these good practices to students context In addition the investigators will propose to the students that they carry out a reflective diary The objective is to generate awareness of the need to improve it allowing the participants to design the interventions based on evidence-based proposals The participants can modify adapt and suggest new interventions participants believe can work out in each center In the research team there are professional experts in knowledge transfer and in the adolescent population therefore the professional experts will advise on how to present the information to each group adapting the local language format and cultural elements The research team will also facilitate the mobilization of resources that allow the implementation of the interventions and when the interventions are implemented the adolescents satisfaction will be evaluated with structured surveys
At the end of the project the investigators will evaluate the adolescent compassion level replaying the same process as the beginning of the project phase 1 Afterward the investigators will do discussion groups again to understand better the impact of the interventions on their compassion perception
Data analysis would be adjusted to PRISMA Preferred Reporting Items for Systematic Reviews and Meta-Analyses indications when the literature review is being carried out Then discussion groups will be recorded and transcribed and will do a critical analysis of the discourse Inductive and deductive strategies will be employed In the inductive phase the different levels of units of meaning are identified in an exhaustive and triangulated manner codes subcategories and categories Each transcribed document will be read and analyzed independently by two researchers In the deductive phase the data will be analyzed from the data obtained from the literature review and theoretical framework
The data were triangulated by two members of the research team and shared The investigators will work responding to reliability and authenticity criteria suggested by Lincoln and Guba credibility transferability dependency and confirmability In addition the rigor criteria established in COREQ-32 Consolidated Criteria for Reporting Qualitative Research were also followed in the design of Phase 2 with qualitative methodology
The investigators will elaborate a survey ad-hoc with quantitative and qualitative items to know participants satisfaction with the intervention organization and their opinions The qualitative results from the ad-hoc evaluation will be analyzed with a content analysis to assess the relevance suitability and impact of each intervention To understand the changes that the project has caused them the investigators will do a critical analysis of the discourse of the discussion groups in the evaluation phase
Before starting the fieldwork approval will be obtained from the research ethics committee of each province All participants who wish to be part of the project will voluntarily sign the informed consent Appropriate anonymization and privacy-preserving methods are employed to ensure the privacy of users when their personally identifiable information is stored processed and shared Special attention and strict legal compliance will be paid to underage adolescent participation As established by Organic Law 11996 -on the Legal Protection of Minors - modified by Law 262015 and Law 452015 Spanish laws the investigators who have any interaction with the minors under study accredit that they have not committed crimes of a sexual nature through a certificate issued by the Spanish Ministry for Justice The present study will be developed by the Declaration of Helsinki and the Good Clinical Practice Guidelines Following the protocol and legal requirements specified by Law 142007 on Biomedical Research and the precepts contained in the European Union EU Chart of Fundamental Rights 2000C 36401 and the EU Regulation 2016679 of the European Parliament will be complied with Participants may exercise all their rights under the Statutory Law Protection of Personal Data and Guaranteeing Digital Rights 32018 and Data Protection Regulation 2016679 Spanish Laws
Identification of critical points and contingency plan The population-based survey study has the limitations of observational studies The fact that members of the educational community recruit and encourage adolescents to participate minimizes the loss of follow-up Limitations of qualitative research relate to participation and data collection therefore more time may be needed to overcome initial distrust and reluctance to join the research Taking into account these limitations the timetable defined has taken into account the characteristics of the population by proposing sufficient time for the PAR process As with all multicenter projects that focus on complex health and social care interventions there are potential risks and barriers The investigators include our contingency plans
1 Risk of not having consistency of approach between regional institutions severity medium risk 20 To risk mitigation the investigators propose early warning systems with frequent monitoring of data collection processes between partners and feedback on progress is arranged by developing a robust communication system early on that will proactively identify and solve problems
2 Delays to empirical work medium risk 20 The project coordinator is well experienced in guiding these kinds of projects Moreover participants are chosen based on their experience in dealing with research in this area and their existing close connections to the site
3 Risk of not recruiting the minimum participants medium risk 15 The commitment made by the participants is for a relatively long period as PAR is a reflective process that requires at least two full cycles per group Critical points will be established for scheduling progressive recruitment therefore in case some point is not reached additional units will be recruited within the institutions
4 High drop-out rate non-valid results due to lack of a representative number of participants medium risk 20 Critical points will be established taking in that conversation about death is often associated with fear anxiety avoidance and misunderstandings in adolescents Many adults feel that these discussions are inappropriate and confusing for young people Before working with teenagers the investigators will explain the project and get their parents consent On the other hand potential institutions that could be influenced first by project results will be analyzed from the first stages of the project and could be potential collaborators
5 Shortage of resources medium risk 20 Consortium agreement between all researchers binds them concerning the availability of resources Early warning systems of monthly time reporting and 6-monthly financial reporting allow to detect problems timely and take action
6 Dissemination activity is ineffective at increasing the visibility of the Project low risk 5 A dissemination strategy is developed early in the project to identify the correct audience and devise strategies to reach them
7 Insufficient interaction with targeted communities low risk 5 Increase the presence of representatives of the target groups in all stages of the project including the exploitation activities Step up the communication in case of not satisfying the target communities intensifying the communication and adapting it even more to their specific needs
These plans are based on tried and tested strategies from previous projects and international implementation papers and the investigators are confident of their robustness In addition the investigators will have an Internal Executive Quality Assurance group within the team whose responsibilities will include four-month assessments of project delivery which will enable the investigators to pre-empt and tackle problems before they arise
PHASE 1 Diagnosis of the situation of compassion through a descriptive observational study that will provide valuable information about understanding compassionate awareness in adolescents and will be useful for rigorously evaluating changes post-intervention in specific groups
To analyze the level of compassion of adolescents in every province the investigators include all the public secondary schools and a public university that belong to the same health area with similar population characteristics in each province In the 6 participating Universities there are 340 degrees and a total of 92103 students enrolled In the 6 Health Areas of the study provinces there are 61 high schools and the population of adolescents enrolled in school is 36486 Thus a random sample of 1852 individuals is enough to estimate with 95 confidence and a precision of - 010 units the population means values that are expected to have a standard deviation of about 156 units
A series of sociodemographic and educational variables will be collected from all participants to describe their characteristics such as age gender level of studies school educational context previous experience with dying people volunteer activities or other personal experience in palliative care PC Compassion will be assessed using the COOLS and adolescents attitudes toward death which will be explored through the DAS The evaluation scales will be distributed to the adolescents requesting their permission to distribute the questionnaires anonymously through the different specific communication channels that each educational center secondary school and university uses to keep up communication with the students The responses will be recorded online in the Research Electronic Data Capture REDCap an electronic data capture software
The investigators will elaborate a descriptive summary document on the level of adolescent compassion in all provinces taking into account variables such as educational context context compassion resources age and gender The investigators will analyze the differential characteristics of sex in compassion from a gender perspective In general the investigators will make descriptive statistics according to the nature of the variables with 95 confidence intervals
PHASE 2 related to the compassion transformation process To understand how the process of sensitization and participatory reflection is capable of transforming compassion the investigators design a PAR study based on the proposal of Stephen Kemmis and Robin McTaggart who suggest a PAR that focuses on the collective change that is produced from the individual reflections of the participants in a social context The research process will be participatory and cooperative to propose and promote effective changes from the participants and their context The project is designed in a sequence of cycles to design interventions implementation and evaluation
Before the activities a literature review will be done by the investigators to identify effective interventions to improve compassionate awareness in adolescents used by other researchers Next the investigators will design a plan of compassionate good practices in a participatory manner through discussion groups with students in secondary schools and universities separately In secondary school the investigators also will do groups with families and teachers separately because they can contribute to adapting these good practices to students context In addition the investigators will propose to the students that they carry out a reflective diary The objective is to generate awareness of the need to improve it allowing the participants to design the interventions based on evidence-based proposals The participants can modify adapt and suggest new interventions participants believe can work out in each center In the research team there are professional experts in knowledge transfer and in the adolescent population therefore the professional experts will advise on how to present the information to each group adapting the local language format and cultural elements The research team will also facilitate the mobilization of resources that allow the implementation of the interventions and when the interventions are implemented the adolescents satisfaction will be evaluated with structured surveys
At the end of the project the investigators will evaluate the adolescent compassion level replaying the same process as the beginning of the project phase 1 Afterward the investigators will do discussion groups again to understand better the impact of the interventions on their compassion perception
Data analysis would be adjusted to PRISMA Preferred Reporting Items for Systematic Reviews and Meta-Analyses indications when the literature review is being carried out Then discussion groups will be recorded and transcribed and will do a critical analysis of the discourse Inductive and deductive strategies will be employed In the inductive phase the different levels of units of meaning are identified in an exhaustive and triangulated manner codes subcategories and categories Each transcribed document will be read and analyzed independently by two researchers In the deductive phase the data will be analyzed from the data obtained from the literature review and theoretical framework
The data were triangulated by two members of the research team and shared The investigators will work responding to reliability and authenticity criteria suggested by Lincoln and Guba credibility transferability dependency and confirmability In addition the rigor criteria established in COREQ-32 Consolidated Criteria for Reporting Qualitative Research were also followed in the design of Phase 2 with qualitative methodology
The investigators will elaborate a survey ad-hoc with quantitative and qualitative items to know participants satisfaction with the intervention organization and their opinions The qualitative results from the ad-hoc evaluation will be analyzed with a content analysis to assess the relevance suitability and impact of each intervention To understand the changes that the project has caused them the investigators will do a critical analysis of the discourse of the discussion groups in the evaluation phase
Before starting the fieldwork approval will be obtained from the research ethics committee of each province All participants who wish to be part of the project will voluntarily sign the informed consent Appropriate anonymization and privacy-preserving methods are employed to ensure the privacy of users when their personally identifiable information is stored processed and shared Special attention and strict legal compliance will be paid to underage adolescent participation As established by Organic Law 11996 -on the Legal Protection of Minors - modified by Law 262015 and Law 452015 Spanish laws the investigators who have any interaction with the minors under study accredit that they have not committed crimes of a sexual nature through a certificate issued by the Spanish Ministry for Justice The present study will be developed by the Declaration of Helsinki and the Good Clinical Practice Guidelines Following the protocol and legal requirements specified by Law 142007 on Biomedical Research and the precepts contained in the European Union EU Chart of Fundamental Rights 2000C 36401 and the EU Regulation 2016679 of the European Parliament will be complied with Participants may exercise all their rights under the Statutory Law Protection of Personal Data and Guaranteeing Digital Rights 32018 and Data Protection Regulation 2016679 Spanish Laws
Identification of critical points and contingency plan The population-based survey study has the limitations of observational studies The fact that members of the educational community recruit and encourage adolescents to participate minimizes the loss of follow-up Limitations of qualitative research relate to participation and data collection therefore more time may be needed to overcome initial distrust and reluctance to join the research Taking into account these limitations the timetable defined has taken into account the characteristics of the population by proposing sufficient time for the PAR process As with all multicenter projects that focus on complex health and social care interventions there are potential risks and barriers The investigators include our contingency plans
1 Risk of not having consistency of approach between regional institutions severity medium risk 20 To risk mitigation the investigators propose early warning systems with frequent monitoring of data collection processes between partners and feedback on progress is arranged by developing a robust communication system early on that will proactively identify and solve problems
2 Delays to empirical work medium risk 20 The project coordinator is well experienced in guiding these kinds of projects Moreover participants are chosen based on their experience in dealing with research in this area and their existing close connections to the site
3 Risk of not recruiting the minimum participants medium risk 15 The commitment made by the participants is for a relatively long period as PAR is a reflective process that requires at least two full cycles per group Critical points will be established for scheduling progressive recruitment therefore in case some point is not reached additional units will be recruited within the institutions
4 High drop-out rate non-valid results due to lack of a representative number of participants medium risk 20 Critical points will be established taking in that conversation about death is often associated with fear anxiety avoidance and misunderstandings in adolescents Many adults feel that these discussions are inappropriate and confusing for young people Before working with teenagers the investigators will explain the project and get their parents consent On the other hand potential institutions that could be influenced first by project results will be analyzed from the first stages of the project and could be potential collaborators
5 Shortage of resources medium risk 20 Consortium agreement between all researchers binds them concerning the availability of resources Early warning systems of monthly time reporting and 6-monthly financial reporting allow to detect problems timely and take action
6 Dissemination activity is ineffective at increasing the visibility of the Project low risk 5 A dissemination strategy is developed early in the project to identify the correct audience and devise strategies to reach them
7 Insufficient interaction with targeted communities low risk 5 Increase the presence of representatives of the target groups in all stages of the project including the exploitation activities Step up the communication in case of not satisfying the target communities intensifying the communication and adapting it even more to their specific needs
These plans are based on tried and tested strategies from previous projects and international implementation papers and the investigators are confident of their robustness In addition the investigators will have an Internal Executive Quality Assurance group within the team whose responsibilities will include four-month assessments of project delivery which will enable the investigators to pre-empt and tackle problems before they arise
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