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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

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

Lieux d'étude

    • New York
      • The Bronx, New York, États-Unis, 10461
        • Albert Einstein College of Medicine

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
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.
Participants review plain-language research summaries generated using a standardized AI prompt without researcher prompt engineering or community co-design.
Expérimental: Researcher prompt engineering - Aim 3
Participants receive summaries generated after researchers complete AI prompt-engineering training and develop optimized prompts.
Participants review AI-generated summaries generated after researchers complete AI prompt-engineering training and develop optimized prompts.
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.
Participants review AI-generated summaries refined through iterative collaboration between researchers and community members using community-engaged co-design principles.
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.
The co-designed summaries which result from this process will become one of the three intervention conditions evaluated in Aim 3.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
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.
Immediately following review of research summary, up to 1 hour
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
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.
Immediately before the co-creation process and immediately following the co-creation process, up to 1 hour

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
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.
Immediately before the co-creation process and immediately following the co-creation process, up to 1 hour
Institutional confidence - Aim 2
Délai: Immediately before the co-creation process and immediately following the co-creation process, 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.
Immediately before the co-creation process and immediately following the co-creation process, up to 1 hour
Research comprehension - Aim 2
Délai: Immediately before the co-creation process and immediately following the co-creation process, 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 before the co-creation process and immediately following the co-creation process, up to 1 hour
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
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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

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

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

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 .

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