An interventional study of interview in Critical Illness and Loss of Consciousness, sponsored by University Hospital Freiburg. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-24.
Sponsored by University Hospital Freiburg · Not applicable, Interventional, and Diagnostic
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.
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 and/or family representatives at an early stage in the planning of trials. The objectives of this study are based on these expectations.
60 studies on the registry are indexed under Unconsciousness; 9 are open to participants now.
This study's planned enrollment of 50 is close to the median of 50 across 37 interventional studies indexed under Unconsciousness.
Browse Unconsciousness studies →University Hospital Freiburg is the lead sponsor of 94 studies on the registry; 18 are open to participants now.
Compared within Unconsciousness, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Critical Illness. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Study intervention: interview with patient relative/LAR
Other: interview
patient relatives or legal authorized representatives will be interviewed
relative/LAR perception
The primary aim of the study is to evaluate the perceptions of LARs towards the recruitment process for clinical trials. This is an exploratory examination. All findings are considered merely hypothesis generating and will be used for designing further trials based on sound hypotheses following the findings from this trial.
Time frame: actual day
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2024 (actual). Primary completion is estimated for Jun 2026, 23 months after the start.
Of 16 interventional studies with no phase under Unconsciousness, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 40. This study's planned 23 months is above that.
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University Hospital Freiburg