ECA vs E-Document Explanation

Literacy Clinical Trial

Official title:

Embodied Conversational Agent as Consent Advocate Compared to E-Consent Administration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03381911
• Other study ID #: H-37101
• Secondary ID: R01CA158219-05
• Status: Completed
• Phase: N/A
• Start date: January 4, 2018
• Est. completion date: April 18, 2018

Study information

• Verified date: July 2018
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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:

1. administer sham consent (via e-consent or ECA per randomization result)

2. knowledge test

3. data collection

1. socio-demographics

2. health literacy assessment (REALM)

3. ECA satisfaction (for ECA arm subjects only)

4. Emotional connection (adapted PROMIS) (for ECA arm subjects only)

4. Debriefing

1. Describe true study aims

2. Opt out option (subject can request that their data not be used)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: April 18, 2018
• Est. primary completion date: April 18, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• English speaking

• able to come in for a single study visit

Exclusion Criteria:

• Deaf

• Blind

Related Conditions & MeSH terms

• Information Disclosure
• Literacy

Intervention

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.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Boston Medical Center	National Cancer Institute (NCI), Northeastern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knowledge of informed consent document	A knowledge test will be given to assess the subjects' level of comprehension of the informed consent form	immediately following the study interview
Secondary	Survey of level of satisfaction with the ECA	For subjects in the ECA study arm, satisfaction with the agent will be assessed	immediately following the study interview
Secondary	Amount of time spent on consent process	The amount of time that the subject spent with the consent form, assessed in both arms	immediately following the study interview