Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
101 participants
INTERVENTIONAL
2015-09-30
2016-09-30
Brief Summary
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Detailed Description
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There is one sub-study, the Images study, also included in this protocol. Subjects who are eligible for the main study can choose if they would like to participate in this sub-study. This is a within-subjects design, where subjects will be randomized to different conditions within the system.
One additional sub-study, called Stance, also a within-subjects design, where subjects will be randomized to different conditions within the system, was also included in the original protocol,but has since been closed to enrollment. Data collection for this sub-study was the same as for the current sub study (Images), and the main study (Consent Advocate).
Eligible subjects will be given the option to participate in the sub-study in addition to the main study. Subjects may opt out of this sub-study, but not the main study (as in, a subject cannot do the sub-study and NOT do the main study, unless there is some legitimate reason to stop after the sub-study). Due to the nature of the content, the order of the studies must be:
Images (sub) Consent Advocate (main) In these studies, baseline data is collected by the RA verbally administering the instruments to the subjects. Then, the subject will sit in front of a touch-screen monitor to interact with the character on the screen. A member of the research team will be available at all times to assist with any technical issues, or if the subject needs to take a break. Once the on-screen interaction(s) are complete, the RA will administer any post-system data collection instruments.
Due to the amount of time required for data collection and completion of study protocol (each study takes approximately 60-120 minutes), the subject can choose to complete the 2 studies in 1 or 2 study visits, depending on study subject and staff scheduling needs.
Main Study: Consent Advocate In this study, the participant will be randomized to one of three arms: 1) a sham research informed consent form will be explained by a research assistant; 2) a sham research informed consent form will be explained by an ECA, or 3) a sham research informed consent form will be explained by an ECA and then questions will be answered by a research assistant.
Baseline Data Collection:
1. Sociodemographics
2. Need for Cognition
3. Patient Activation
4. Trust in Medical System
5. REALM
Post Data Collection:
1. BICEP (primary outcome measure)
2. Trust in Agent
3. Instructor Evaluation Permission to audiotape the interaction will be obtained prior to conducting this portion of the sub-study. The audio recording will be used to analyze what questions the participant asks. If assigned to the ECA and RA condition, the audio recording will be used by the research assistant prior to conducting the live consent process. A knowledge test will be conducted after the consent process to ascertain what was understood.
This study should take approximately 60 minutes to complete.
Sub-study:
1\. Images. The ECA will explain a consent form but will use images to represent potential risk as opposed to descriptive language only. Understanding will be measured by a knowledge questionnaire. (n=50)
Baseline Data Collection:
Sociodemographics Need for Cognition
Post Data Collection:
Instructor Evaluation Informed Consent Scales Knowledge (of sham consent form) This study should take approximately 60-90 minutes to complete. If a subject participates in the sub-study that requires the same data collection forms (i.e. sociodemographics, need for cognition, etc), these forms will only be completed once for each subject, not for each study they participate in.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Human RA
A sham research informed consent form will be explained by a research assistant
No interventions assigned to this group
ECA
A sham research informed consent form will be explained by an ECA (embodied conversational agent as presented on a touch screen computer)
Embodied Conversational Agent
A computer generated character that can administer informed consent to a potential research subject.
ECA + Human RA
A sham research informed consent form will be explained by an ECA and then questions will be answered by a research assistant
Embodied Conversational Agent
A computer generated character that can administer informed consent to a potential research subject.
Interventions
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Embodied Conversational Agent
A computer generated character that can administer informed consent to a potential research subject.
Eligibility Criteria
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Inclusion Criteria
2. Must be an established patient in the Boston Medical Center clinics.
Exclusion Criteria
21 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Northeastern University
OTHER
Boston Medical Center
OTHER
Responsible Party
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Michael Paasche-Orlow
BMC Attending Physician
Principal Investigators
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Michael Paasche-Orlow, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Boston Medical Center
Locations
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Boston Medical Center
Boston, Massachusetts, United States
Countries
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Other Identifiers
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CA158219-CA
Identifier Type: -
Identifier Source: org_study_id