- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07788898
AI-enabled Communication to Advance Research Engagement (AI-CARE) (AI-CARE)
31 agosto 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Stimato)
250
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Jessica Kahn, MD, MPH
- Numero di telefono: 718-430-4317
- Email: jessica.kahn@einsteinmd.edu
Luoghi di studio
-
-
New York
-
The Bronx, New York, Stati Uniti, 10461
- Albert Einstein College of Medicine
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Sì
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
|
Sperimentale: 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.
|
|
Sperimentale: 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.
|
|
Sperimentale: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Confidence in medical research and researchers - Aim 3
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Perceived appropriateness of research summary - Aim 2
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Jessica Kahn, MD, MPH, Albert Einstein College of Medicine
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 ottobre 2026
Completamento primario (Stimato)
1 settembre 2028
Completamento dello studio (Stimato)
1 settembre 2028
Date di iscrizione allo studio
Primo inviato
24 agosto 2026
Primo inviato che soddisfa i criteri di controllo qualità
24 agosto 2026
Primo Inserito (Effettivo)
27 agosto 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
2 settembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
31 agosto 2026
Ultimo verificato
1 agosto 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 2026-17824
- UM1TR004400 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano IPD
A data management and sharing plan was not created for this grant.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .