LiteracyNCT03381911
ECA vs E-Document Explanation
A study testing Embodied Conversational Agent in people with Literacy and Information Disclosure, run by Boston Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Literacy, Information Disclosure
- What is being tested?
- Embodied Conversational Agent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2018to 18 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English speaking
- able to come in for a single study visit
Who cannot join
- Deaf
- Blind
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Embodied Conversational Agent as Consent Advocate Compared to E-Consent Administration
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.
Read the detailed 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:
- 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)
- Conditions
- Literacy, Information Disclosure
- Being tested
- Embodied Conversational Agent
- Medical subject headings
- Literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embodied Conversational AgentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| E-Consent | No intervention | 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. |
| ECA Consent | Experimental | 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. Receives: Other: Embodied Conversational Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge of informed consent document
A knowledge test will be given to assess the subjects' level of comprehension of the informed consent form
Measured: immediately following the study interview
Secondary outcomes (2)
Survey of level of satisfaction with the ECA
For subjects in the ECA study arm, satisfaction with the agent will be assessed
Measured: 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
Measured: immediately following the study interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2017
- Study start4 Jan 2018
- Primary completion18 Apr 2018
- Study completion18 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LiteracyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are 2 study arms: ECA and E-Consent. In the ECA group subjects will have the consent form reviewed with them by the Embodied Conversational Agent character. In the E-Consent group (the standard of care), subjects will review the consent form on a computer screen with the option to have it read to them verbatim.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Northeastern University, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Michael Paasche-Orlow, Boston Medical Center
- Investigators
- Michael Paasche-Orlow, MD, MPH, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03381911
- Sponsor's protocol ID
- H-37101
- Other IDs
- R01CA158219-05
- Status last verified
- Jul 2018
- First submitted
- 6 Dec 2017
- Last updated
- 12 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Embodied Conversational Agent as Consent Advocate Compared to E-Consent Administration
- ClinicalTrials.gov ID
- NCT03381911
- Acronym / sponsor ID
- H-37101
- Conditions
- Literacy, Information Disclosure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Northeastern University, National Cancer Institute (NCI)
- Study start
- 4 Jan 2018 (actual)
- Primary completion
- 18 Apr 2018 (actual)
- Study completion
- 18 Apr 2018 (actual)
- First posted
- 22 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- 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)
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There are 2 study arms: ECA and E-Consent. In the ECA group subjects will have the consent form reviewed with them by the Embodied Conversational Agent character. In the E-Consent group (the standard of care), subjects will review the consent form on a computer screen with the option to have it read to them verbatim.
| Arm | Type | Receives |
|---|---|---|
| E-Consent | No intervention | –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. |
| ECA Consent | Experimental | Other: Embodied Conversational AgentIn 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- English speaking
- able to come in for a single study visit
Key exclusion criteria (2 listed)
- Deaf
- Blind
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Embodied Conversational AgentThe 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. | Other | ECA Consent |
Primary outcome
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
2 secondary outcomes
Survey of level of satisfaction with the ECA
Time frame: immediately following the study interview
Amount of time spent on consent process
Time frame: immediately following the study interview
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Paasche-Orlow, MD, MPH principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embodied Conversational Agent in people with Literacy and Information Disclosure, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge of informed consent document (time frame: immediately following the study interview). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2018.