Skip to main content
OpenTrials
Completed

NCT Number: NCT03381911

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 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Literacy Behavior Communication Information Disclosure

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

About this study

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:

  • administer sham consent (via e-consent or ECA per randomization result)
  • knowledge test
  • data collection
  • socio-demographics
  • health literacy assessment (REALM)
  • ECA satisfaction (for ECA arm subjects only)
  • Emotional connection (adapted PROMIS) (for ECA arm subjects only)
  • Debriefing
  • Describe true study aims
  • Opt out option (subject can request that their data not be used)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • English speaking
  • able to come in for a single study visit

Exclusion criteria

  • Deaf
  • Blind

Treatment and study plan

Embodied Conversational Agent

Other

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.

Primary outcomes

  1. Knowledge of informed consent document

    Time frame: immediately following the study interview

    A knowledge test will be given to assess the subjects' level of comprehension of the informed consent form

Secondary outcomes

  1. Survey of level of satisfaction with the ECA

    Time frame: immediately following the study interview

    For subjects in the ECA study arm, satisfaction with the agent will be assessed

  2. Amount of time spent on consent process

    Time frame: immediately following the study interview

    The amount of time that the subject spent with the consent form, assessed in both arms

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)
  • Northeastern University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 22, 2017
Registry last updated
Jul 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.