- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07788898
AI-enabled Communication to Advance Research Engagement (AI-CARE) (AI-CARE)
31 de agosto de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Estimado)
250
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Jessica Kahn, MD, MPH
- Número de telefone: 718-430-4317
- E-mail: jessica.kahn@einsteinmd.edu
Locais de estudo
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New York
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The Bronx, New York, Estados Unidos, 10461
- Albert Einstein College of Medicine
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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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Experimental: 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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Experimental: 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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Experimental: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Confidence in medical research and researchers - Aim 3
Prazo: 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
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Perceived appropriateness of research summary - Aim 2
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.
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Immediately following review of research summary, up to 1 hour
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Jessica Kahn, MD, MPH, Albert Einstein College of Medicine
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de outubro de 2026
Conclusão Primária (Estimado)
1 de setembro de 2028
Conclusão do estudo (Estimado)
1 de setembro de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
24 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
24 de agosto de 2026
Primeira postagem (Real)
27 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
2 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
31 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 2026-17824
- UM1TR004400 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
A data management and sharing plan was not created for this grant.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .