An interventional study of Embodied Conversational Agent in Literacy and Information Disclosure, sponsored by Boston Medical Center. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-12.
Sponsored by Boston Medical Center · Not applicable, Interventional, and Health services research
This study will investigate how consent forms and other health care documents are explained to patients. The findings will be used to create a computer program that can successfully explain consent and other health-related forms to individuals who have difficulty reading and understanding consent forms on their own as a supplement to the normal consent process done in research settings.
In a prior study, the investigators delivered a similar protocol, where subjects were first consented and then given a mock consent form (administered in 1 of 3 arms: RA, ECA, or ECA + RA). Subjects in this protocol struggled with the concept of a "mock" consent process, especially after they had just completed a consent process for the study itself. The current protocol, using deception research methods, aims to provide a more pure assessment of ECA consent vs the standard (here, E-consent) by waiving consent and delivering the sham consent as if it were reality. In the context of a protocol that employs deception methods, participants in the current study would be invited as healthy volunteers, and be randomized to 1 of 2 different consent processes to evaluate the relative benefits of different approaches for informed consent. After the knowledge tests have been completed, subjects will undergo a debriefing where they are made fully aware of the deception and its purpose. At that time, subjects will also be given the opportunity to "opt out" and not have their data included in the study results.
Participants who call in response to the clinic flyers will first confirm eligibility criteria of age (≥21) and language (able to complete a study visit in English). Once eligibility is confirmed, participants will be scheduled to come to BMC for a single study visit that will take approximately 60-90 minutes. Randomization to one study arm or the other will occur when subject arrives for appointment.
The following activities will occur at a single study visit:
data collection
Debriefing
201 studies on the registry are indexed under Literacy; 69 are open to participants now.
This study's enrollment of 35 is below the median of 124 across 170 interventional studies indexed under Literacy.
Browse Literacy studies →Boston Medical Center is the lead sponsor of 323 studies on the registry; 33 are open to participants now.
Of its 34 completed or terminated interventional studies of FDA-regulated products, 28 (82%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
This arm is the standard of care, where the consent form is presented to the subject on a computer screen and he/she can scroll ahead and back as needed. There is also an option to have each screen read aloud.
In this arm an Embodied Conversational Agent (ECA) which is a computer generated character reads the consent form aloud to the subject, and also describes each section using a pre-loaded script. In addition, the character performs "teach-back", where she asks the subject a question about the section that was just described, and then repeats the section if the question is answered incorrectly.
Other: Embodied Conversational Agent
The Embodied Conversational Agent (ECA) is a computer generated character that can interact with study subjects through a touch screen computer. The ECA is programmed to respond with relevant speech and body language to a subject's responses.
Knowledge of informed consent document
A knowledge test will be given to assess the subjects' level of comprehension of the informed consent form
Time frame: immediately following the study interview
Survey of level of satisfaction with the ECA
For subjects in the ECA study arm, satisfaction with the agent will be assessed
Time frame: immediately following the study interview
Amount of time spent on consent process
The amount of time that the subject spent with the consent form, assessed in both arms
Time frame: immediately following the study interview
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2018 to primary completion in Apr 2018, 3 months.
Of 115 non-industry interventional studies with no phase under Literacy, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 20. This study's 3 months is below that.
Counting every sponsor, half of 117 studies reached it within 11 months; a quarter within 4 and three quarters within 19.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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