- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07788898
AI-enabled Communication to Advance Research Engagement (AI-CARE) (AI-CARE)
31. august 2026 oppdatert av: Albert Einstein College of Medicine
AI-enabled Communication to Advance Research Engagement
The objective of AI-CARE is to train researchers and community members to use artificial intelligence (AI) to create plain-language summaries of research studies and to determine whether a co-creation process for developing these summaries improves understanding and relevance of the research, confidence in AI and in institutions, and AI literacy.
The hypothesis is that AI-generated research summaries, co-developed with researchers and community partners, will significantly improve confidence in research and institutions, understanding and accessibility of the research, and appropriateness of the summary compared with standard researcher-generated materials, and that the educational and co-creation process will build community members' AI literacy and confidence in using AI, as well as researchers' readiness to use and comfort with using AI for communicating research.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Detaljert beskrivelse
This research project consists of four specific aims.
Specific Aims 2 and 3 meet the NIH definition of a clinical trial.
Accordingly, this ClinicalTrials.gov
registration describes only the clinical trial conducted under Specifics Aims 2 and 3.
The remaining aims involve non-interventional research activities and are not included in this registration.
Aims 2 and 3 are an intentional sequential design.
Studietype
Intervensjonell
Registrering (Antatt)
250
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Jessica Kahn, MD, MPH
- Telefonnummer: 718-430-4317
- E-post: jessica.kahn@einsteinmd.edu
Studiesteder
-
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New York
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The Bronx, New York, Forente stater, 10461
- Albert Einstein College of Medicine
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
Inclusion Criteria:
- English-speaking individuals at least 18 years of age
Exclusion Criteria:
- Individuals unable to provide informed consent
- Participants who have had formal training in AI prompt engineering
The eligibility criteria are common to both Aims 2 and 3.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Standard AI prompt - Aim 3
Participants receive plain-language research summaries generated using a standardized AI prompt without researcher prompt engineering or community co-design.
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Participants review plain-language research summaries generated using a standardized AI prompt without researcher prompt engineering or community co-design.
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Eksperimentell: Researcher prompt engineering - Aim 3
Participants receive summaries generated after researchers complete AI prompt-engineering training and develop optimized prompts.
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Participants review AI-generated summaries generated after researchers complete AI prompt-engineering training and develop optimized prompts.
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Eksperimentell: Community co-created AI summaries - Aim 3
Participants receive summaries developed through an iterative community-researcher co-creation process following AI training and structured co-design sessions.
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Participants review AI-generated summaries refined through iterative collaboration between researchers and community members using community-engaged co-design principles.
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Eksperimentell: Co-creation cohort - Aim 2
Participants will be divided into three groups, each assigned 1-2 research summaries, and will engage in structured co-creation sessions.
The goals of will be to: 1) define readability and appropriateness, 2) review AI-generated drafts produced by the summary engine, and 3) provide feedback to refine prompts and outputs.
Several iteration cycles will be conducted as needed, with documentation of any changes and the rationale for making decisions.
In this way the team will develop a modular AI "summary engine" that transforms research products (e.g., manuscripts) into draft community-facing materials using co-created prompts and templates.
Co-creation will be conducted during one or two facilitated sessions.
Each session will include structured review of drafts, guided discussion, and documented decisions regarding readability, transparency, visuals or graphics, etc. Iteration cycles will continue until pre-specified stopping criteria are met.
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The co-designed summaries which result from this process will become one of the three intervention conditions evaluated in Aim 3.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Confidence in medical research and researchers - Aim 3
Tidsramme: Immediately following review of research summary, up to 1 hour
|
This is the primary outcome measure for both Aim 2 and Aim 3.
This outcome measure will be assessed using subscale 1 of the PoRT scale.
PoRT is a validated, self-report measure that assesses confidence in medical research and researchers.
Subscale 1 contains 9 items, with response options for each item ranging from 1 (strongly disagree) to 5 (strongly agree); thus the subscale ranges from 9 to 45. Higher scores indicate higher confidence.
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Immediately following review of research summary, up to 1 hour
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Confidence in medical research and researchers - Aim 2
Tidsramme: Immediately before the co-creation process and immediately following the co-creation process, up to 1 hour
|
This is the primary outcome measure for both Aim 2 and Aim 3.
This outcome measure will be assessed using subscale 1 of the PoRT scale.
PoRT is a validated, self-report measure that assesses confidence in medical research and researchers.
Subscale 1 contains 9 items, with response options for each item ranging from 1 (strongly disagree) to 5 (strongly agree); thus the subscale ranges from 9 to 45. Higher scores indicate higher confidence.
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Immediately before the co-creation process and immediately following the co-creation process, up to 1 hour
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Perceived appropriateness of research summary - Aim 2
Tidsramme: Immediately before the co-creation process and immediately following the co-creation process, up to 1 hour
|
Perceived appropriateness of research summary will be assessed using an 8-item scale adapted from the literature which measures community and personal relevance, fit and respect, language and representation, and confidence and resonance (each of the four constructs is measured using two items).
Responses for the eight items range from 1=strongly disagree to 5=strongly agree; possible scale score thus ranges from 8 to 40.
Higher scores indicate higher perceived appropriateness.
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Immediately before the co-creation process and immediately following the co-creation process, up to 1 hour
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Institutional confidence - Aim 2
Tidsramme: Immediately before the co-creation process and immediately following the co-creation process, up to 1 hour
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This is a validated measure of confidence in health care institutions, assessed using the MMI scale which contains 7 items.
Responses range from 1 (strongly disagree) to 5 (strongly agree); thus, the range of scale scores is 7 to 35.
Lower scores indicate higher confidence.
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Immediately before the co-creation process and immediately following the co-creation process, up to 1 hour
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Research comprehension - Aim 2
Tidsramme: Immediately before the co-creation process and immediately following the co-creation process, up to 1 hour
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Research study specific comprehension which will consist of 25 true-false statements (5 items for each of the 5 research studies chosen by researchers and community participants that will be used for creation of plain-language summaries).
Correct answers = 1, and incorrect answers = 0.
The range will be 0 to 25, with higher scores indicating better comprehension.
|
Immediately before the co-creation process and immediately following the co-creation process, up to 1 hour
|
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Perceived appropriateness of research summary - Aim 3
Tidsramme: Immediately following review of research summary, up to 1 hour
|
Perceived appropriateness of research summary will be assessed using an 8-item scale adapted from the literature which measures community and personal relevance, fit and respect, language and representation, and confidence and resonance (each of the four constructs is measured using two items).
Responses for the eight items range from 1=strongly disagree to 5=strongly agree; possible scale score thus ranges from 8 to 40.
Higher scores indicate higher perceived appropriateness.
|
Immediately following review of research summary, up to 1 hour
|
|
Institutional confidence - Aim 3
Tidsramme: Aim 3: Immediately following review of research summary, up to 1 hour
|
This is a validated measure of confidence in health care institutions, assessed using the MMI scale which contains 7 items.
Responses range from 1 (strongly disagree) to 5 (strongly agree); thus, the range of scale scores is 7 to 35.
Lower scores indicate higher confidence.
|
Aim 3: Immediately following review of research summary, up to 1 hour
|
|
Research comprehension - Aim 3
Tidsramme: Immediately following review of research summary, up to 1 hour
|
Research study specific comprehension which will consist of 25 true-false statements (5 items for each of the 5 research studies chosen by researchers and community participants that will be used for creation of plain-language summaries).
Correct answers = 1, and incorrect answers = 0.
The range will be 0 to 25, with higher scores indicating better comprehension.
|
Immediately following review of research summary, up to 1 hour
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Jessica Kahn, MD, MPH, Albert Einstein College of Medicine
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Kreuter MW, Wray RJ. Tailored and targeted health communication: strategies for enhancing information relevance. Am J Health Behav. 2003 Nov-Dec;27 Suppl 3:S227-32. doi: 10.5993/ajhb.27.1.s3.6.
- Shoemaker SJ, Wolf MS, Brach C. Development of the Patient Education Materials Assessment Tool (PEMAT): a new measure of understandability and actionability for print and audiovisual patient information. Patient Educ Couns. 2014 Sep;96(3):395-403. doi: 10.1016/j.pec.2014.05.027. Epub 2014 Jun 12.
- Snyder HR, Miyake A, Hankin BL. Advancing understanding of executive function impairments and psychopathology: bridging the gap between clinical and cognitive approaches. Front Psychol. 2015 Mar 26;6:328. doi: 10.3389/fpsyg.2015.00328. eCollection 2015.
- Marafino BJ, Dudley RA, Shah NH, Chen JH. Accurate and interpretable intensive care risk adjustment for fused clinical data with generalized additive models. AMIA Jt Summits Transl Sci Proc. 2018 May 18;2017:166-175. eCollection 2018.
- O'Connor MA, Erasmus JH, Randall S, Archer J, Lewis TB, Brown B, Fredericks M, Groenier S, Iwayama N, Ahrens C, Garrison W, Wangari S, Guerriero KA, Fuller DH. A Single Dose SARS-CoV-2 Replicon RNA Vaccine Induces Cellular and Humoral Immune Responses in Simian Immunodeficiency Virus Infected and Uninfected Pigtail Macaques. Front Immunol. 2021 Dec 21;12:800723. doi: 10.3389/fimmu.2021.800723. eCollection 2021.
- Holzer JK, Ellis L, Merritt MW. Why we need community engagement in medical research. J Investig Med. 2014 Aug;62(6):851-5. doi: 10.1097/JIM.0000000000000097.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. oktober 2026
Primær fullføring (Antatt)
1. september 2028
Studiet fullført (Antatt)
1. september 2028
Datoer for studieregistrering
Først innsendt
24. august 2026
Først innsendt som oppfylte QC-kriteriene
24. august 2026
Først lagt ut (Faktiske)
27. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
2. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
31. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 2026-17824
- UM1TR004400 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
A data management and sharing plan was not created for this grant.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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. .