[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653732":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":44,"studyPopulation":33,"armGroups":45,"interventions":67,"overallOfficials":85,"centralContacts":89,"locations":94,"responsibleParty":107,"collaborators":109,"id":113,"slug":114,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":121,"sex":122,"minAge":123,"maxAge":33,"enrollmentInfo":124,"targetDuration":33,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":134,"overallStatus":137,"whyStopped":33,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"Albert Einstein College of Medicine","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":33},[9,13],{"measure":10,"description":11,"timeFrame":12},"Confidence in medical research and researchers - Aim 3","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",{"measure":14,"description":11,"timeFrame":15},"Confidence in medical research and researchers - Aim 2","Immediately before the co-creation process and immediately following the co-creation process, up to 1 hour",[17,20,23,26,28,31],{"measure":18,"description":19,"timeFrame":15},"Perceived appropriateness of research summary - Aim 2","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.",{"measure":21,"description":22,"timeFrame":15},"Institutional confidence - Aim 2","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.",{"measure":24,"description":25,"timeFrame":15},"Research comprehension - Aim 2","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.",{"measure":27,"description":19,"timeFrame":12},"Perceived appropriateness of research summary - Aim 3",{"measure":29,"description":22,"timeFrame":30},"Institutional confidence - Aim 3","Aim 3: Immediately following review of research summary, up to 1 hour",{"measure":32,"description":25,"timeFrame":12},"Research comprehension - Aim 3",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":37,"primaryPurpose":6,"observationalModel":33,"timePerspective":33,"maskingInfo":38},"RANDOMIZED","PARALLEL","Aim 2: Single group: participants are prospectively assigned to an intervention (AI literacy training and co-design) to evaluate the effect of the intervention on health-related behavioral outcomes. Because only one response is allowed for allocation and number of participants, please note that allocation is N\u002FA and number of participants is 40.\n\nAim 3: Parallel: participants are randomized 1:1:1 to one of three summary types to compare the effect of the intervention on health-related behavioral outcomes. Because only one response is allowed for allocation and number of participants, please note that allocation is randomized, and number of participants is 210.",{"masking":39,"maskingDescription":40,"whoMasked":41},"DOUBLE","Aim 2: N\u002FA Aim 3: Participants are blinded to how the research summaries were developed. The summaries are presented in identical formats without identifying the development method. Study personnel performing the primary analyses remain blinded to treatment assignment until completion of the primary analyses.",[42,43],"PARTICIPANT","OUTCOMES_ASSESSOR","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.",[46,52,57,62],{"label":47,"type":48,"description":49,"interventionNames":50},"Standard AI prompt - Aim 3","EXPERIMENTAL","Participants receive plain-language research summaries generated using a standardized AI prompt without researcher prompt engineering or community co-design.",[51],"Behavioral: Experimental: Standard AI prompt",{"label":53,"type":48,"description":54,"interventionNames":55},"Researcher prompt engineering - Aim 3","Participants receive summaries generated after researchers complete AI prompt-engineering training and develop optimized prompts.",[56],"Behavioral: Experimental: Researcher prompt engineering",{"label":58,"type":48,"description":59,"interventionNames":60},"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.",[61],"Behavioral: Community co-created AI summaries",{"label":63,"type":48,"description":64,"interventionNames":65},"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.",[66],"Behavioral: AI literacy training and co-design",[68,73,77,81],{"type":69,"name":70,"description":71,"armGroupLabels":72,"otherNames":33},"BEHAVIORAL","Community co-created AI summaries","Participants review AI-generated summaries refined through iterative collaboration between researchers and community members using community-engaged co-design principles.",[58],{"type":69,"name":74,"description":75,"armGroupLabels":76,"otherNames":33},"Experimental: Researcher prompt engineering","Participants review AI-generated summaries generated after researchers complete AI prompt-engineering training and develop optimized prompts.",[53],{"type":69,"name":78,"description":79,"armGroupLabels":80,"otherNames":33},"Experimental: Standard AI prompt","Participants review plain-language research summaries generated using a standardized AI prompt without researcher prompt engineering or community co-design.",[47],{"type":69,"name":82,"description":83,"armGroupLabels":84,"otherNames":33},"AI literacy training and co-design","The co-designed summaries which result from this process will become one of the three intervention conditions evaluated in Aim 3.",[63],[86],{"name":87,"affiliation":5,"role":88},"Jessica Kahn, MD, MPH","PRINCIPAL_INVESTIGATOR",[90],{"name":87,"role":91,"phone":92,"phoneExt":33,"email":93},"CONTACT","718-430-4317","jessica.kahn@einsteinmd.edu",[95],{"facility":5,"status":33,"city":96,"state":97,"zip":98,"country":99,"countryCode":100,"cosmosGeoPoint":101,"geoPoint":106,"contacts":33},"The Bronx","New York","10461","United States","US",{"type":102,"coordinates":103},"Point",[104,105],-73.86641,40.84985,{"lat":105,"lon":104},{"type":108,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR",[110],{"name":111,"class":112},"National Center for Advancing Translational Sciences (NCATS)","NIH","100653732","ai-enabled-communication-to-advance-research-engagement-ai-care-100653732",false,"NCT07788898","AI-enabled Communication to Advance Research Engagement (AI-CARE)","AI-enabled Communication to Advance Research Engagement","AI-CARE","Inclusion Criteria:\n\n* English-speaking individuals at least 18 years of age\n\nExclusion Criteria:\n\n* Individuals unable to provide informed consent\n* Participants who have had formal training in AI prompt engineering\n\nThe eligibility criteria are common to both Aims 2 and 3.",true,"ALL","18 Years",{"count":125,"type":126},250,"ESTIMATED","INTERVENTIONAL",[129],"NA","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.",[132,133],"Health Literacy","Health Communication",[135,136],"AI literacy","AI communication","NOT_YET_RECRUITING","2026-08-31",{"date":140,"type":141},"2026-09-02","ACTUAL",{"date":143,"type":126},"2026-10-01",{"date":145,"type":126},"2028-09-01",{"name":5,"class":6},1]