- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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)
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Massachusetts
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Boston, Massachusetts, Forente stater, 02118
- Boston Medical Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- English speaking
- able to come in for a single study visit
Exclusion Criteria:
- Deaf
- Blind
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Ingen inngripen: 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.
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Eksperimentell: 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.
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Knowledge of informed consent document
Tidsramme: immediately following the study interview
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A knowledge test will be given to assess the subjects' level of comprehension of the informed consent form
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immediately following the study interview
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Survey of level of satisfaction with the ECA
Tidsramme: immediately following the study interview
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For subjects in the ECA study arm, satisfaction with the agent will be assessed
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immediately following the study interview
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Amount of time spent on consent process
Tidsramme: immediately following the study interview
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The amount of time that the subject spent with the consent form, assessed in both arms
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immediately following the study interview
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- H-37101
- R01CA158219-05 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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