Ignite Creation Date:
2024-07-17 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06471400
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-18
Brief Title:
Developing Strategies to Facilitate Consent of Legally Authorized Representatives to Clinical Trials
Sponsor:
University Hospital Freiburg
Organization:
University Hospital Freiburg
Study Overview
Official Title:
Developing Strategies to Facilitate Consent of Legally Authorized Representatives to Clinical Trials - a Prospective Single-arm Open-label Exploratory Trial
Status:
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:
This study aims to gather insights into the perceptions of legal representatives regarding the recruitment process for clinical trials in the intensive care setting when the patients cannot decide for themselves With this information effective strategies will be developed to increase involvement and the feeling of ownership of LARs of potential participants in clinical trials and thus enhance and facilitate patient recruitment for clinical trials The single-arm study design does not include a choice of comparator as the focus of this trial is to explore the perceptions of the participants at first hand without comparing different cohorts or strategies
Detailed Description:
The evidence for specific therapies and treatment strategies particularly for critically ill patients remains limited A significant difficulty for the planning initiation and implementation of clinical trials in these patients is the urgency of the necessary medical measures which leaves patients and their relatives as well as the treating clinicians little time and opportunities to present necessary studies and to inform the patients or their legal guardians about them Critically ill patients are a particularly vulnerable group of patients The measures required as part of a study can mean additional efforts for these patients over and above the burden of the disease and the necessary diagnostic and therapeutic measures which are only justified if special duties of care are observed In addition to an ethical assessment of the study this also includes providing comprehensive information to patients or their legal representatives
In this study the process of informing and educating patients or their legal representatives will be examined in more detail The aim of the study is to gain a better understanding of this process in particular the perceptions and views of the persons to be informed and specifically to investigate which aspects are particularly important to patients and their legal representatives in an information and education discussion and what information they need in order to be able to consider participating in a study or what reasons exist that would prevent them from giving their consent The overall aim of this study is to improve the information and education process
For some years now the involvement of patients and relatives in individual aspects of the planning and conduct of clinical trials has been increasingly demanded and promoted For example large public funders often require the involvement of patient andor family representatives at an early stage in the planning of trials The objectives of this study are based on these expectations
In this study the process of informing and educating patients or their legal representatives will be examined in more detail The aim of the study is to gain a better understanding of this process in particular the perceptions and views of the persons to be informed and specifically to investigate which aspects are particularly important to patients and their legal representatives in an information and education discussion and what information they need in order to be able to consider participating in a study or what reasons exist that would prevent them from giving their consent The overall aim of this study is to improve the information and education process
For some years now the involvement of patients and relatives in individual aspects of the planning and conduct of clinical trials has been increasingly demanded and promoted For example large public funders often require the involvement of patient andor family representatives at an early stage in the planning of trials The objectives of this study are based on these expectations
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