Developing Strategies to Facilitate Consent of Legally Authorized Representatives to Clinical Trials

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity Hospital Freiburg

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

The study will include LARs of adult patients aged 18 years or older who are admitted to the Freiburg University Medical Center in Germany.

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • interview

    Other intervention

    patient relatives or legal authorized representatives will be interviewed

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Patient relative/LAR interviewOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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