Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07788898

AI-enabled Communication to Advance Research Engagement (AI-CARE)

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Community co-created AI summaries

Behavioral

Participants review AI-generated summaries refined through iterative collaboration between researchers and community members using community-engaged co-design principles.

Experimental: Researcher prompt engineering

Behavioral

Participants review AI-generated summaries generated after researchers complete AI prompt-engineering training and develop optimized prompts.

Experimental: Standard AI prompt

Behavioral

Participants review plain-language research summaries generated using a standardized AI prompt without researcher prompt engineering or community co-design.

AI literacy training and co-design

Behavioral

The co-designed summaries which result from this process will become one of the three intervention conditions evaluated in Aim 3.

Primary outcomes

  1. Confidence in medical research and researchers - Aim 3

    Time frame: 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.

  2. Confidence in medical research and researchers - Aim 2

    Time frame: 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.

Secondary outcomes

  1. Perceived appropriateness of research summary - Aim 2

    Time frame: 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.

  2. Institutional confidence - Aim 2

    Time frame: 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.

  3. Research comprehension - Aim 2

    Time frame: 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.

  4. Perceived appropriateness of research summary - Aim 3

    Time frame: 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.

  5. Institutional confidence - Aim 3

    Time frame: 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.

  6. Research comprehension - Aim 3

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Kahn, MD, MPH

CONTACT

[email protected]

718-430-4317

Sponsors and collaborators

Lead sponsor

Albert Einstein College of Medicine

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

AI-enabled Communication to Advance Research Engagement

Acronym: AI-CARE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 27, 2026
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.