Mental CompetencyNCT02668705
Agent-Enhanced Document Explanation
A study testing Embodied Conversational Agent in people with Mental Competency, run by Boston Medical Center at 1 site in United States.
Trial summary
Both the main and sub-studies 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… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Competency
- What is being tested?
- Embodied Conversational Agent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Sep 2016
- 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
- understand spoken and written English (assessed by verbally asking candidates if they "understand spoken and written English")
- Must be an established patient in the Boston Medical Center clinics.
Who cannot join
- An issue determined by the patient's physician that would make this study inappropriate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Research Ethics and Safety Promoted by Embodied Conversational Technology
Both the main and sub-studies 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.
Read the detailed description
The main study in this protocol is a 3 arm (HUMAN vs. ECA vs. ECA + HUMAN), randomized, between-subjects experimental design.
There is one sub-study, the Images study, also included in this protocol. Subjects who are eligible for the main study can choose if they would like to participate in this sub-study. This is a within-subjects design, where subjects will be randomized to different conditions within the system.
One additional sub-study, called Stance, also a within-subjects design, where subjects will be randomized to different conditions within the system, was also included in the original protocol,but has since been closed to enrollment. Data collection for this sub-study was the same as for the current sub study (Images), and the main study (Consent Advocate).
Eligible subjects will be given the option to participate in the sub-study in addition to the main study. Subjects may opt out of this sub-study, but not the main study (as in, a subject cannot do the sub-study and NOT do the main study, unless there is some legitimate reason to stop after the sub-study). Due to the nature of the content, the order of the studies must be:
Images (sub) Consent Advocate (main) In these studies, baseline data is collected by the RA verbally administering the instruments to the subjects. Then, the subject will sit in front of a touch-screen monitor to interact with the character on the screen. A member of the research team will be available at all times to assist with any technical issues, or if the subject needs to take a break. Once the on-screen interaction(s) are complete, the RA will administer any post-system data collection instruments.
Due to the amount of time required for data collection and completion of study protocol (each study takes approximately 60-120 minutes), the subject can choose to complete the 2 studies in 1 or 2 study visits, depending on study subject and staff scheduling needs.
Main Study: Consent Advocate In this study, the participant will be randomized to one of three arms: 1) a sham research informed consent form will be explained by a research assistant; 2) a sham research informed consent form will be explained by an ECA, or 3) a sham research informed consent form will be explained by an ECA and then questions will be answered by a research assistant.
Baseline Data Collection:
- Sociodemographics
- Need for Cognition
- Patient Activation
- Trust in Medical System
- REALM
Post Data Collection:
- BICEP (primary outcome measure)
- Trust in Agent
- Instructor Evaluation Permission to audiotape the interaction will be obtained prior to conducting this portion of the sub-study. The audio recording will be used to analyze what questions the participant asks. If assigned to the ECA and RA condition, the audio recording will be used by the research assistant prior to conducting the live consent process. A knowledge test will be conducted after the consent process to ascertain what was understood.
This study should take approximately 60 minutes to complete.
Sub-study:
- Images. The ECA will explain a consent form but will use images to represent potential risk as opposed to descriptive language only. Understanding will be measured by a knowledge questionnaire. (n=50)
Baseline Data Collection:
Sociodemographics Need for Cognition
Post Data Collection:
Instructor Evaluation Informed Consent Scales Knowledge (of sham consent form) This study should take approximately 60-90 minutes to complete. If a subject participates in the sub-study that requires the same data collection forms (i.e. sociodemographics, need for cognition, etc), these forms will only be completed once for each subject, not for each study they participate in.
- Conditions
- Mental Competency
- Being tested
- Embodied Conversational Agent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embodied Conversational AgentOther
A computer generated character that can administer informed consent to a potential research subject.
| Study group | Role | What they receive |
|---|---|---|
| Human RA | No intervention | A sham research informed consent form will be explained by a research assistant |
| ECA | Experimental | A sham research informed consent form will be explained by an ECA (embodied conversational agent as presented on a touch screen computer) Receives: Other: Embodied Conversational Agent |
| ECA + Human RA | Experimental | A sham research informed consent form will be explained by an ECA and then questions will be answered by a research assistant Receives: Other: Embodied Conversational Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
the quality of the informed consent process
as determined by verbally administering the Brief Informed Consent Evaluation Protocol (BICEP) instrument.
Measured: immediately following the study interview
Secondary outcomes (1)
knowledge of the mock study that was described during study visit
determined by knowledge assessment test
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 posted29 Jan 2016 (estimated)
- Study startSep 2015
- Primary completionSep 2016
- Study completionSep 2016
Why it stopped: Interim analysis showed no difference between either arm of the intervention.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental CompetencyStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Northeastern University
- 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
- NCT02668705
- Sponsor's protocol ID
- CA158219-CA
- Other IDs
- 5R01CA158219-05
- Status last verified
- Nov 2016
- First submitted
- 27 Jan 2016
- Last updated
- 25 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Ethics and Safety Promoted by Embodied Conversational Technology
- ClinicalTrials.gov ID
- NCT02668705
- Acronym / sponsor ID
- CA158219-CA
- Conditions
- Mental Competency
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis showed no difference between either arm of the intervention.
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Northeastern University
- Study start
- Sep 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 29 Jan 2016 (estimated)
- 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.
Both the main and sub-studies 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.
Detailed description
The main study in this protocol is a 3 arm (HUMAN vs. ECA vs. ECA + HUMAN), randomized, between-subjects experimental design.
There is one sub-study, the Images study, also included in this protocol. Subjects who are eligible for the main study can choose if they would like to participate in this sub-study. This is a within-subjects design, where subjects will be randomized to different conditions within the system.
One additional sub-study, called Stance, also a within-subjects design, where subjects will be randomized to different conditions within the system, was also included in the original protocol,but has since been closed to enrollment. Data collection for this sub-study was the same as for the current sub study (Images), and the main study (Consent Advocate).
Eligible subjects will be given the option to participate in the sub-study in addition to the main study. Subjects may opt out of this sub-study, but not the main study (as in, a subject cannot do the sub-study and NOT do the main study, unless there is some legitimate reason to stop after the sub-study). Due to the nature of the content, the order of the studies must be:
Images (sub) Consent Advocate (main) In these studies, baseline data is collected by the RA verbally administering the instruments to the subjects. Then, the subject will sit in front of a touch-screen monitor to interact with the character on the screen. A member of the research team will be available at all times to assist with any technical issues, or if the subject needs to take a break. Once the on-screen interaction(s) are complete, the RA will administer any post-system data collection instruments.
Due to the amount of time required for data collection and completion of study protocol (each study takes approximately 60-120 minutes), the subject can choose to complete the 2 studies in 1 or 2 study visits, depending on study subject and staff scheduling needs.
Main Study: Consent Advocate In this study, the participant will be randomized to one of three arms: 1) a sham research informed consent form will be explained by a research assistant; 2) a sham research informed consent form will be explained by an ECA, or 3) a sham research informed consent form will be explained by an ECA and then questions will be answered by a research assistant.
Baseline Data Collection:
- Sociodemographics
- Need for Cognition
- Patient Activation
- Trust in Medical System
- REALM
Post Data Collection:
- BICEP (primary outcome measure)
- Trust in Agent
- Instructor Evaluation Permission to audiotape the interaction will be obtained prior to conducting this portion of the sub-study. The audio recording will be used to analyze what questions the participant asks. If assigned to the ECA and RA condition, the audio recording will be used by the research assistant prior to conducting the live consent process. A knowledge test will be conducted after the consent process to ascertain what was understood.
This study should take approximately 60 minutes to complete.
Sub-study:
- Images. The ECA will explain a consent form but will use images to represent potential risk as opposed to descriptive language only. Understanding will be measured by a knowledge questionnaire. (n=50)
Baseline Data Collection:
Sociodemographics Need for Cognition
Post Data Collection:
Instructor Evaluation Informed Consent Scales Knowledge (of sham consent form) This study should take approximately 60-90 minutes to complete. If a subject participates in the sub-study that requires the same data collection forms (i.e. sociodemographics, need for cognition, etc), these forms will only be completed once for each subject, not for each study they participate in.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Human RA | No intervention | –A sham research informed consent form will be explained by a research assistant |
| ECA | Experimental | Other: Embodied Conversational AgentA sham research informed consent form will be explained by an ECA (embodied conversational agent as presented on a touch screen computer) |
| ECA + Human RA | Experimental | Other: Embodied Conversational AgentA sham research informed consent form will be explained by an ECA and then questions will be answered by a research assistant |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- understand spoken and written English (assessed by verbally asking candidates if they "understand spoken and written English")
- Must be an established patient in the Boston Medical Center clinics.
Key exclusion criteria (1 listed)
- An issue determined by the patient's physician that would make this study inappropriate.
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 AgentA computer generated character that can administer informed consent to a potential research subject. | Other | ECA, ECA + Human RA |
Primary outcome
the quality of the informed consent process
Time frame: immediately following the study interview
as determined by verbally administering the Brief Informed Consent Evaluation Protocol (BICEP) instrument.
1 secondary outcome
knowledge of the mock study that was described during study visit
Time frame: immediately following the study interview
Results and safety
The study was stopped early (reason given: Interim analysis showed no difference between either arm of the intervention.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2016.
- 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 Mental Competency, 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 1 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: stopped early, as of the sponsor's last update on 25 Nov 2016. 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 was stopped early (reason given: Interim analysis showed no difference between either arm of the intervention.). Results are not available in the source record.
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?
the quality of the informed consent process (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 25 Nov 2016.