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NCT03381911 · ClinicalTrials.gov registry record · NA
ECA vs E-Document Explanation
A NA study, sponsored by Boston Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 35
- Enrollment target
NCT03381911 is a NA study that has completed, run by Boston Medical Center. The registered enrollment target is 35 participants.
The verdict
NCT03381911, a NA study, has completed, sponsored by Boston Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 35 participants
- Enrollment target
Study Summary
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.
Interventions
- OTHER Embodied Conversational Agent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2018-01-04 |
| Est. Completion | 2018-04-18 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03381911
The ClinicalTrials.gov registry entry for NCT03381911 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Medical Center, which has 253 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Embodied Conversational Agent is the first listed.
NCT03381911 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03381911 about?
NCT03381911 is a clinical study titled "ECA vs E-Document Explanation". 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 fo...
What is the current status of trial NCT03381911?
This trial is currently completed. It is a NA study. The enrollment target is 35 participants. The study started on 2018-01-04. Estimated completion is 2018-04-18.
What interventions are being tested in trial NCT03381911?
The interventions under investigation include: Embodied Conversational Agent (OTHER).
Who is sponsoring clinical trial NCT03381911?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
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