Critical IllnessNCT06471400
Developing Strategies to Facilitate Consent of Legally Authorized Representatives to Clinical Trials
A study testing interview in people with Critical Illness and Loss of Consciousness, run by University Hospital Freiburg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Critical Illness, Loss of Consciousness
- What is being tested?
- interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 18 Jun 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The study will include LARs of adult patients aged 18 years or older who are admitted to the Freiburg University Medical Center in Germany.
Who cannot join
- LARs who have expressed their unwillingness to participate in the study or have objected to the measures implemented in the study will not be included.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Freiburg University Medical Center
Freiburg im Breisgau, 79106
Alexander Supady, MD, +4976127034010, alexander.supady@uniklinik-freiburg.de
About this study
Official title: Developing Strategies to Facilitate Consent of Legally Authorized Representatives to Clinical Trials - a Prospective, Single-arm, Open-label Exploratory Trial
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.
Read the 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 and/or family representatives at an early stage in the planning of trials. The objectives of this study are based on these expectations.
- Conditions
- Critical Illness, Loss of Consciousness
- Being tested
- interview
- Medical subject headings
- Critical Illness, Unconsciousness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interviewOther
patient relatives or legal authorized representatives will be interviewed
| Study group | Role | What they receive |
|---|---|---|
| Patient relative/LAR interview | Other | Study intervention: interview with patient relative/LAR Receives: Other: interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: actual day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start18 Jun 2024
- Primary completion17 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PD Dr. Alexander Supady, University Hospital Freiburg
- Investigators
- Alexander Supady, MD, Principal investigator, Freiburg University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471400
- Sponsor's protocol ID
- 23-1162-S1
- Status last verified
- Jun 2024
- First submitted
- 18 Jun 2024
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Strategies to Facilitate Consent of Legally Authorized Representatives to Clinical Trials - a Prospective, Single-arm, Open-label Exploratory Trial
- ClinicalTrials.gov ID
- NCT06471400
- Acronym / sponsor ID
- 23-1162-S1
- Conditions
- Critical Illness, Loss of Consciousness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- 17 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 and/or family representatives at an early stage in the planning of trials. The objectives of this study are based on these expectations.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient relative/LAR interview | Other | Other: interviewStudy intervention: interview with patient relative/LAR |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The study will include LARs of adult patients aged 18 years or older who are admitted to the Freiburg University Medical Center in Germany.
Key exclusion criteria (1 listed)
- LARs who have expressed their unwillingness to participate in the study or have objected to the measures implemented in the study will not be included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interviewpatient relatives or legal authorized representatives will be interviewed | Other | Patient relative/LAR interview |
Primary outcome
relative/LAR perception
Time frame: actual day
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexander Supady, MD principal investigator
Freiburg University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interview in people with Critical Illness and Loss of Consciousness, run by University Hospital Freiburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander Supady, MD (+4976127034010, alexander.supady@uniklinik-freiburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relative/LAR perception (time frame: actual day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.