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

NCT06471400 | Recruiting

• 1 other identifier: 23-1162-S1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Loss of Consciousness

Outcome Measures

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.

  actual day

Study Arms (1)

Patient relative/LAR interview

OTHER

Study intervention: interview with patient relative/LAR

Other: interview

Interventions

interview OTHER

patient relatives or legal authorized representatives will be interviewed

Patient relative/LAR interview

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Freiburg: lead

Study Sites (1)

Freiburg University Medical Center

Freiburg im Breisgau, 79106, Germany

RECRUITING

MeSH Terms

Conditions

Critical Illness; Unconsciousness

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Alexander Supady, MD

  Freiburg University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Supady, MD

CONTACT

+4976127034010; alexander.supady@uniklinik-freiburg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 24, 2024
• Study Start: June 18, 2024
• Primary Completion (Estimated): June 17, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)