- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07788898
AI-enabled Communication to Advance Research Engagement (AI-CARE) (AI-CARE)
maanantai 31. elokuuta 2026 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Ei vielä rekrytointia
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Interventio
Ilmoittautuminen (Arvioitu)
250
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskeluyhteys
- Nimi: Jessica Kahn, MD, MPH
- Puhelinnumero: 718-430-4317
- Sähköposti: jessica.kahn@einsteinmd.edu
Opiskelupaikat
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New York
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The Bronx, New York, Yhdysvallat, 10461
- Albert Einstein College of Medicine
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Joo
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Muut
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kaksinkertainen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: 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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Kokeellinen: 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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Kokeellinen: 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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Kokeellinen: 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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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Confidence in medical research and researchers - Aim 3
Aikaikkuna: Immediately following review of research summary, up to 1 hour
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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
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Perceived appropriateness of research summary - Aim 2
Aikaikkuna: 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 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
Aikaikkuna: 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
Aikaikkuna: 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.
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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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Perceived appropriateness of research summary - Aim 3
Aikaikkuna: 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
Aikaikkuna: 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
|
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Research comprehension - Aim 3
Aikaikkuna: 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
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Jessica Kahn, MD, MPH, Albert Einstein College of Medicine
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Yleiset julkaisut
- 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.
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Torstai 1. lokakuuta 2026
Ensisijainen valmistuminen (Arvioitu)
Perjantai 1. syyskuuta 2028
Opintojen valmistuminen (Arvioitu)
Perjantai 1. syyskuuta 2028
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Maanantai 24. elokuuta 2026
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Maanantai 24. elokuuta 2026
Ensimmäinen Lähetetty (Todellinen)
Torstai 27. elokuuta 2026
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Keskiviikko 2. syyskuuta 2026
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Maanantai 31. elokuuta 2026
Viimeksi vahvistettu
Lauantai 1. elokuuta 2026
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muut tutkimustunnusnumerot
- 2026-17824
- UM1TR004400 (Yhdysvaltain NIH-apuraha/sopimus)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
EI
IPD-suunnitelman kuvaus
A data management and sharing plan was not created for this grant.
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Ei
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Ei
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .