- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03381911
ECA vs E-Document Explanation
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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)
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Massachusetts
-
Boston, Massachusetts, Förenta staterna, 02118
- Boston Medical Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- English speaking
- able to come in for a single study visit
Exclusion Criteria:
- Deaf
- Blind
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Inget ingripande: E-Consent
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.
|
|
Experimentell: ECA Consent
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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Knowledge of informed consent document
Tidsram: immediately following the study interview
|
A knowledge test will be given to assess the subjects' level of comprehension of the informed consent form
|
immediately following the study interview
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Survey of level of satisfaction with the ECA
Tidsram: immediately following the study interview
|
For subjects in the ECA study arm, satisfaction with the agent will be assessed
|
immediately following the study interview
|
Amount of time spent on consent process
Tidsram: immediately following the study interview
|
The amount of time that the subject spent with the consent form, assessed in both arms
|
immediately following the study interview
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- H-37101
- R01CA158219-05 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
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