- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07788898
AI-enabled Communication to Advance Research Engagement (AI-CARE) (AI-CARE)
31 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
250
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Jessica Kahn, MD, MPH
- Numéro de téléphone: 718-430-4317
- E-mail: jessica.kahn@einsteinmd.edu
Lieux d'étude
-
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New York
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The Bronx, New York, États-Unis, 10461
- Albert Einstein College of Medicine
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Expérimental: 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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Expérimental: 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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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Confidence in medical research and researchers - Aim 3
Délai: 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
Délai: Immediately before the co-creation process and immediately following the co-creation process, 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 before the co-creation process and immediately following the co-creation process, up to 1 hour
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Perceived appropriateness of research summary - Aim 2
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Jessica Kahn, MD, MPH, Albert Einstein College of Medicine
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 octobre 2026
Achèvement primaire (Estimé)
1 septembre 2028
Achèvement de l'étude (Estimé)
1 septembre 2028
Dates d'inscription aux études
Première soumission
24 août 2026
Première soumission répondant aux critères de contrôle qualité
24 août 2026
Première publication (Réel)
27 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
2 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
31 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 2026-17824
- UM1TR004400 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
A data management and sharing plan was not created for this grant.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .