Health LiteracyAI-CARENCT07788898
AI-enabled Communication to Advance Research Engagement (AI-CARE)
A study testing Community co-created AI summaries, Experimental: Researcher prompt engineering and Experimental: Standard AI prompt in people with Health Literacy and Health Communication, run by Albert Einstein College of Medicine at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Literacy, Health Communication
- What is being tested?
- Community co-created AI summaries, Experimental: Researcher prompt engineering and Experimental: Standard AI prompt
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English-speaking individuals at least 18 years of age
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Health Literacy, Health Communication
- Being tested
- Community co-created AI summaries, Experimental: Researcher prompt engineering, Experimental: Standard AI prompt, AI literacy training and co-design
- Keywords
- AI literacy, AI communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community co-created AI summariesBehavioural
Participants review AI-generated summaries refined through iterative collaboration between researchers and community members using community-engaged co-design principles.
Experimental: Researcher prompt engineeringBehavioural
Participants review AI-generated summaries generated after researchers complete AI prompt-engineering training and develop optimized prompts.
Experimental: Standard AI promptBehavioural
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-designBehavioural
The co-designed summaries which result from this process will become one of the three intervention conditions evaluated in Aim 3.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Experimental: Standard AI prompt |
| Researcher prompt engineering - Aim 3 | Experimental | Participants receive summaries generated after researchers complete AI prompt-engineering training and develop optimized prompts. Receives: Behavioral: Experimental: Researcher prompt engineering |
| Community co-created AI summaries - Aim 3 | Experimental | Participants receive summaries developed through an iterative community-researcher co-creation process following AI training and structured co-design sessions. Receives: Behavioral: Community co-created AI summaries |
| Co-creation cohort - Aim 2 | Experimental | 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. Receives: Behavioral: AI literacy training and co-design |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately following review of research summary, up to 1 hour
Confidence in medical research and researchers - Aim 2
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.
Measured: Immediately before the co-creation process and immediately following the co-creation process, up to 1 hour
Secondary outcomes (6)
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.
Measured: Immediately before the co-creation process and immediately following the co-creation process, up to 1 hour
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.
Measured: Immediately before the co-creation process and immediately following the co-creation process, up to 1 hour
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.
Measured: Immediately before the co-creation process and immediately following the co-creation process, up to 1 hour
Perceived appropriateness of research summary - Aim 3
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.
Measured: Immediately following review of research summary, up to 1 hour
Institutional confidence - Aim 3
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.
Measured: Aim 3: Immediately following review of research summary, up to 1 hour
Research comprehension - Aim 3
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.
Measured: Immediately following review of research summary, up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Health LiteracyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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/A and number of participants is 40. Aim 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Jessica Kahn, MD, MPH, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788898
- Sponsor's protocol ID
- 2026-17824
- Other IDs
- UM1TR004400
- Acronym
- AI-CARE
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A data management and sharing plan was not created for this grant.
Publications
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.
PubMed 24973195Snyder 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.
PubMed 25859234Marafino 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.
PubMed 29888065O'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.
PubMed 34992610Kreuter 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.
PubMed 14672383Holzer 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.
PubMed 24979468
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-enabled Communication to Advance Research Engagement
- ClinicalTrials.gov ID
- NCT07788898
- Acronym / sponsor ID
- AI-CARE / 2026-17824
- Conditions
- Health Literacy, Health Communication
- Keywords
- AI literacy, AI communication
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- 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/A and number of participants is 40. Aim 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.
| Arm | Type | Receives |
|---|---|---|
| Standard AI prompt - Aim 3 | Experimental | Behavioral: Experimental: Standard AI promptParticipants receive plain-language research summaries generated using a standardized AI prompt without researcher prompt engineering or community co-design. |
| Researcher prompt engineering - Aim 3 | Experimental | Behavioral: Experimental: Researcher prompt engineeringParticipants receive summaries generated after researchers complete AI prompt-engineering training and develop optimized prompts. |
| Community co-created AI summaries - Aim 3 | Experimental | Behavioral: Community co-created AI summariesParticipants receive summaries developed through an iterative community-researcher co-creation process following AI training and structured co-design sessions. |
| Co-creation cohort - Aim 2 | Experimental | Behavioral: AI literacy training and co-designParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- English-speaking individuals at least 18 years of age
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community co-created AI summariesParticipants review AI-generated summaries refined through iterative collaboration between researchers and community members using community-engaged co-design principles. | Behavioural | Community co-created AI summaries - Aim 3 |
| Experimental: Researcher prompt engineeringParticipants review AI-generated summaries generated after researchers complete AI prompt-engineering training and develop optimized prompts. | Behavioural | Researcher prompt engineering - Aim 3 |
| Experimental: Standard AI promptParticipants review plain-language research summaries generated using a standardized AI prompt without researcher prompt engineering or community co-design. | Behavioural | Standard AI prompt - Aim 3 |
| AI literacy training and co-designThe co-designed summaries which result from this process will become one of the three intervention conditions evaluated in Aim 3. | Behavioural | Co-creation cohort - Aim 2 |
Primary outcome
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.
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.
6 secondary outcomes
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
Institutional confidence - Aim 2
Time frame: Immediately before the co-creation process and immediately following the co-creation process, up to 1 hour
Research comprehension - 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 - Aim 3
Time frame: Immediately following review of research summary, up to 1 hour
Institutional confidence - Aim 3
Time frame: Aim 3: Immediately following review of research summary, up to 1 hour
Research comprehension - Aim 3
Time frame: Immediately following review of research summary, up to 1 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Background: PubMed 24973195Shoemaker 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.
- Background: PubMed 25859234Snyder 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.
- Background: PubMed 29888065Marafino 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.
- Background: PubMed 34992610O'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.
- Background: PubMed 14672383Kreuter 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.
- Background: PubMed 24979468Holzer 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.
- Individual participant dataSharing planned: No. A data management and sharing plan was not created for this grant.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jessica Kahn, MD, MPH principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community co-created AI summaries, Experimental: Researcher prompt engineering and Experimental: Standard AI prompt in people with Health Literacy and Health Communication, run by Albert Einstein College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Kahn, MD, MPH (718-430-4317, jessica.kahn@einsteinmd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confidence in medical research and researchers - Aim 3 (time frame: Immediately following review of research summary, up to 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07788898, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.