Study Stopped
Interim analysis showed no difference between either arm of the intervention.
Agent-Enhanced Document Explanation
Research Ethics and Safety Promoted by Embodied Conversational Technology
2 other identifiers
interventional
101
1 country
1
Brief 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 forms on their own as a supplement to the normal consent process done in research settings.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 27, 2016
CompletedFirst Posted
Study publicly available on registry
January 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedNovember 25, 2016
November 1, 2016
1 year
January 27, 2016
November 22, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
the quality of the informed consent process
as determined by verbally administering the Brief Informed Consent Evaluation Protocol (BICEP) instrument.
immediately following the study interview
Secondary Outcomes (1)
knowledge of the mock study that was described during study visit
immediately following the study interview
Study Arms (3)
Human RA
NO INTERVENTIONA sham research informed consent form will be explained by a research assistant
ECA
EXPERIMENTALA sham research informed consent form will be explained by an ECA (embodied conversational agent as presented on a touch screen computer)
ECA + Human RA
EXPERIMENTALA sham research informed consent form will be explained by an ECA and then questions will be answered by a research assistant
Interventions
A computer generated character that can administer informed consent to a potential research subject.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- An issue determined by the patient's physician that would make this study inappropriate.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston Medical Centerlead
- National Cancer Institute (NCI)collaborator
- Northeastern Universitycollaborator
Study Sites (1)
Boston Medical Center
Boston, Massachusetts, 02118, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Paasche-Orlow, MD, MPH
Boston Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- BMC Attending Physician
Study Record Dates
First Submitted
January 27, 2016
First Posted
January 29, 2016
Study Start
September 1, 2015
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
November 25, 2016
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will not share