Community Enhanced Virtual Informed Consent
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
The goal of this clinical trial is to examine perceptions of virtual human communicators and cancer research recruitment messages. This study will also examine how different informed consent approaches influence decisions to participate in research.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Able to speak, read, or understand English sufficiently to provide informed consent
18 years of age or older
White or Black
Living in the United States
Disqualifiers
Unable to speak, read, or understand English sufficiently to provide informed consent
Inability on the part of the patient to understand the informed consent or be compliant with the protocol
Trial design
Design model
Parallel
Treatments tested in this trial
Educational Cancer Intervention
BehavioralParticipants will view informed consent messaging presented in different formats
ICF Text Version 1
Other interventionReceive a text-based informed consent form
ICF Text Version 2
Other interventionReceive an adapted text-based informed consent form
ICF Video Version 1
Other interventionReceive a video-based informed consent form delivered by virtual human #1
ICF Video Version 2
Other interventionReceive a video-based informed consent form delivered by virtual human #2
ICF Video Version 3
Other interventionReceive a video-based informed consent form delivered by virtual human #3
ICF Video Version 4
Other interventionReceive a video-based informed consent form delivered by virtual human #4
Survey Administration
Other interventionAncillary studies
Treatment groups
600 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Arm I - ICF Text Version 1Experimental treatment 3 interventions
Group B: Arm II - ICF Text Version 2Experimental treatment 3 interventions
Group C: Arm III - ICF Video Version 1Experimental treatment 3 interventions
Group D: Arm IV - ICF Video Version 2Experimental treatment 3 interventions
Group E: Arm V - ICF Video Version 3Experimental treatment 3 interventions
Group F: Arm VI - ICF Video Version 4Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Self-efficacy (Aim 1)
Assessed by 3 questions in the study-specific survey. The questions are answered on a scale of 1 (strongly disagree) to 5=strongly agree. Higher scores indicate greater feelings of self-efficacy.
Time frame
Baseline (immediately following intervention)2
Trustworthiness (Aim 2)
Assessed by a study-specific survey asking participants to rate the intervention on a scale of 1 (untrustworthy) to 7 (trustworthy). Higher scores indicate greater perception of trustworthiness.
Time frame
Baseline (immediately following intervention)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov