Cardiovascular DiseasesCONNECTNCT06347484
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
A study testing EHR-informed Recruitment Method of Contact and Educational Text-Messages and Connection to Cardiovascular Research Opportunities in people with Cardiovascular Diseases and Hypertension, run by Johns Hopkins University at 1 site in United States.
Trial summary
The CONNECT: "Developing a learning COmmunity to increase eNgagemeNt and Enrollment in cardiovascular Clinical Trials" is comprehensive, participant-centered learning platform designed to increase diversity in cardiovascular disease research among women and Black and Latino adults. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Hypertension, Diabetes Type 2
- What is being tested?
- EHR-informed Recruitment Method of Contact and Educational Text-Messages and Connection to Cardiovascular Research Opportunities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2024to Oct 2026
- 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
- Participant is 18 years or older
- Residing in the US
- Self-identifies as having cardiovascular disease or cardiovascular risk factors
- Has a mobile phone and is willing to receive text-messages
- Can read in English or Spanish
Who cannot join
- Unwilling or unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Nursing
Baltimore, Maryland, 21205
About this study
Official title: Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials
The CONNECT: "Developing a learning COmmunity to increase eNgagemeNt and Enrollment in cardiovascular Clinical Trials" is comprehensive, participant-centered learning platform designed to increase diversity in cardiovascular disease research among women and Black and Latino adults. CONNECT will deploy electronic health record (EHR)-informed and community-engaged recruitment approaches to identify and recruit adults with cardiovascular disease or a cardiovascular disease risk factor to join CONNECT. Participants who join CONNECT will receive tailored educational information on cardiovascular health and research participation via text message. Participants will also have the opportunity to be connected to ongoing cardiovascular research studies based on basic demographic information and areas of interest. The educational information will be sent to participants for 12 months. The CONNECT platform will be used to evaluate recruitment methods. The investigators hypothesize the proportion of women and Black and Latin adults enrolled in trials that partner with CONNECT will be higher following the use of CONNECT for recruitment. Investigators also hypothesize that participating in CONNECT will increase participants' clinical trial awareness, trust, and willingness to participate in clinical trials.
Read the detailed description
The CONNECT project, titled "Developing a learning COmmunity to increase eNgagemeNt and Enrollment in cardiovascular Clinical Trials," seeks to establish an comprehensive learning platform aimed at improving diversity and representation in cardiovascular research. It encompasses three primary objectives:
- Identifying best practices for research recruitment and engagement among women and Black and Latino adults.
- Increasing participation in cardiovascular health research among women and Black and Latino adults.
- Improving trust in and awareness of cardiovascular research among women and Black and Latino adults.
A multi-method recruitment campaign will be implemented, utilizing both electronic health record (EHR)-informed and community-based strategies. A sub-study will be conducted to understand the effectiveness of EHR-informed recruitment. This sub-study will randomly assign a subsample of individuals identified in the EHR to one of three outreach modalities: patient portal message, email, and postal mail. Enrollment yield will be calculated for each recruitment method, with logistic regression modeling estimating the odds of enrollment by recruitment outreach type, both overall and among different demographic groups.
Upon enrollment, participants will specify preferences for receiving text messages regarding heart health, research education, and study opportunities. Messaging will focus on cardiovascular health prevention, management strategies, and research processes, with the aim of fostering trust in research within the community. Pre-post surveys will be distributed to assess changes in clinical trial awareness, trust in medical research, and willingness to participate in trials at baseline, 6 months, and 12 months post-enrollment. Interaction terms will be used to evaluate differences in outcomes by race, ethnicity, and sex.
The process for matching participants to research within the CONNECT project involves individual researchers submitting requests to the CONNECT study team for access to the learning community as a recruitment resource, followed by approval Institutional Review Board (IRB) approval. Upon access, researchers can retrieve, and view records of participants matched to respective studies, ensuring access only to data pertinent to the research objectives. Verification of IRB approval is mandated, and the CONNECT study team will request documentation from the individual research team's IRB to confirm compliance before granting access. Researchers using CONNECT must document eligibility and enrollment data for each CONNECT participant matched to the participants study. Proportions of participants matched to and enrolled in ongoing research studies will be tabulated and compared across demographic groups.
- Conditions
- Cardiovascular Diseases, Hypertension, Diabetes Type 2, Stroke, Recruitment, Overweight and Obesity
- Being tested
- EHR-informed Recruitment Method of Contact, Educational Text-Messages and Connection to Cardiovascular Research Opportunities
- Keywords
- Recruitment, Diversity, Inclusion, Clinical Trials, Cardiovascular Disease, Community Engagement, Registry, Digital Health
- Medical subject headings
- Cardiovascular Diseases, Hypertension, Diabetes Mellitus, Type 2, Stroke, Overweight, Obesity, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EHR-informed Recruitment Method of ContactBehavioural
The intervention being studied here is the method of contact (patient portal vs. email vs. postal mail) after being identified in the EHR
Educational Text-Messages and Connection to Cardiovascular Research OpportunitiesBehavioural
All participants who enroll in CONNECT, regardless of method of contact, will receive educational text messages and connection to cardiovascular research opportunities. Text messages will be tailored and include content on cardiovascular health promotion and research participation.
| Study group | Role | What they receive |
|---|---|---|
| Educational Text-Messages and Connection to Cardiovascular Research Opportunities | Experimental | All participants who enroll in CONNECT, regardless of method of contact, will receive educational text messages and connection to cardiovascular research opportunities. Receives: Behavioral: Educational Text-Messages and Connection to Cardiovascular Research Opportunities |
| EHR-Informed Recruitment Sub-Study #1, Arm #1: Contact Method, Patient Portal Message | Active comparator | Potential participants will be identified using an EHR query and will be randomized to receive a recruitment message via the patient portal message. This message will invite the participant to join CONNECT. Receives: Behavioral: EHR-informed Recruitment Method of Contact |
| EHR-Informed Recruitment Sub-Study #1, Arm #2: Contact Method, Email | Active comparator | Potential participants will be identified using an EHR query and will be randomized to receive a recruitment message via email. This message will invite the participant to join CONNECT. Receives: Behavioral: EHR-informed Recruitment Method of Contact |
| EHR-Informed Recruitment Sub-Study #1, Arm #3: Contact Method, Postal Mail | Active comparator | Potential participants will be identified using an EHR query and will be randomized to receive a recruitment message via postal mail. This message will invite the participant to join CONNECT. Receives: Behavioral: EHR-informed Recruitment Method of Contact |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant accrual by priority population
The total number of participants enrolled in CONNECT, divided by the total number recruited. This will be completed for each recruitment method (EHR-Informed vs. Community-Engaged)
Measured: Baseline
Participant accrual by recruitment method
The total number of participants enrolled in CONNECT, divided by the total number recruited. This will be completed for each priority population (women, Black, and Latino Adults).
Measured: Baseline
Secondary outcomes (4)
Participant accrual in partnering cardiovascular research studies
The proportion of CONNECT participants who enroll into a cardiovascular research study.
Measured: Baseline, 6-months, and 12-months
Trust in Biomedical Research using the Perceptions of Research Trustworthiness Scale (PoRT)
Trust in biomedical research among participants will be assessed using an 18-item instrument, the Perceptions of Research Trustworthiness Scale (PoRT). Possible scores range from 1 (Definitely Disagree) to 5 (Definitely Agree), with 1 indicating higher trust and 5 indicating lower trust.
Measured: Baseline, 6-months, and 12-months
Clinical trials awareness and knowledge will be assessed using items adapted from the Health Information National Trends Survey (HINTS)
Awareness of clinical trials will be assessed by asking participants, "Have you ever heard of a clinical trial?" with response options including "Yes," "No," or "Don't Know." While level of knowledge about clinical trials will be assessed by asking participants to describe level of knowledge about clinical trials, with response options including "I don't know anything about clinical trials," "I know a little bit about clinical trials," and "I know a lot about clinical trials."
Measured: Baseline, 6-months, and 12-months
Willingness to participate in research will be measured by asking participants one related question
Participants will be asked, "In the future, if you developed a health problem like heart disease, would you consider joining a clinical trial that was testing a new heart disease treatment that could help you?" Response options include: "I would not participate," "I might participate," "I probably would participate," "I definitely would participate," and "Not sure/haven't thought about it."
Measured: Baseline, 6-months, and 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start4 May 2024
- Primary completion31 Dec 2025
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Model description
- Participants enrolling in CONNECT will receive tailored educational text messages and opportunities to join cardiovascular research studies. Recruitment will occur via electronic health record (EHR)-informed and community-engaged methods. Enrollment yield will be evaluated for all outreach modalities, both overall and by priority populations (women and Black and Latino adults). The study will also assess participant trust in biomedical research, awareness of clinical trials, and willingness to participate at baseline, 6 months, and 12 months. Sub-study 1: This sub-study will evaluate the effectiveness of three EHR-informed outreach methods: patient portal message, email, and postal mail. Potentially eligible individuals will be identified through EHR query and randomly assigned to one of these methods. Enrollment yield will be assessed by outreach method and priority population.
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Morgan State University, American Heart Association
- Responsible party
- Sponsor
- Investigators
- Hailey N Miller, PhD, RN, Principal investigator, Johns Hopkins School of NursingCheryl R Dennison Himmelfarb, PhD, RN, ANP, Principal investigator, Johns Hopkins School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06347484
- Sponsor's protocol ID
- IRB00411716
- Acronym
- CONNECT
- Status last verified
- Jan 2026
- First submitted
- 29 Mar 2024
- Last updated
- 6 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Miller HN, Wong E, Byiringiro S, Hussain Z, Guerrero Vazquez M, Lewis-Land C, Skelton B, Curriero S, Foster A, Moghimi F, Tomiwa O, Shaia J, Sheikhattari P, Wang NY, Dennison Himmelfarb CR. CONNECT Platform to Increase Diverse Engagement and Enrollment in Cardiovascular Clinical Research: Rationale, Design, and Lessons Learned in Early Implementation. J Am Heart Assoc. 2025 Aug 19;14(16):e038351. doi: 10.1161/JAHA.124.038351. Epub 2025 Aug 12.
PubMed 40792590
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials
- ClinicalTrials.gov ID
- NCT06347484
- Acronym / sponsor ID
- CONNECT / IRB00411716
- Conditions
- Cardiovascular Diseases, Hypertension, Diabetes Type 2, Stroke, Recruitment, Overweight and Obesity
- Keywords
- Recruitment, Diversity, Inclusion, Clinical Trials, Cardiovascular Disease, Community Engagement, Registry, Digital Health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Morgan State University, American Heart Association
- Study start
- 4 May 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- Oct 2026 (estimated)
- First posted
- 4 Apr 2024 (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 CONNECT: "Developing a learning COmmunity to increase eNgagemeNt and Enrollment in cardiovascular Clinical Trials" is comprehensive, participant-centered learning platform designed to increase diversity in cardiovascular disease research among women and Black and Latino adults. CONNECT will deploy electronic health record (EHR)-informed and community-engaged recruitment approaches to identify and recruit adults with cardiovascular disease or a cardiovascular disease risk factor to join CONNECT. Participants who join CONNECT will receive tailored educational information on cardiovascular health and research participation via text message. Participants will also have the opportunity to be connected to ongoing cardiovascular research studies based on basic demographic information and areas of interest. The educational information will be sent to participants for 12 months. The CONNECT platform will be used to evaluate recruitment methods. The investigators hypothesize the proportion of women and Black and Latin adults enrolled in trials that partner with CONNECT will be higher following the use of CONNECT for recruitment. Investigators also hypothesize that participating in CONNECT will increase participants' clinical trial awareness, trust, and willingness to participate in clinical trials.
Detailed description
The CONNECT project, titled "Developing a learning COmmunity to increase eNgagemeNt and Enrollment in cardiovascular Clinical Trials," seeks to establish an comprehensive learning platform aimed at improving diversity and representation in cardiovascular research. It encompasses three primary objectives:
- Identifying best practices for research recruitment and engagement among women and Black and Latino adults.
- Increasing participation in cardiovascular health research among women and Black and Latino adults.
- Improving trust in and awareness of cardiovascular research among women and Black and Latino adults.
A multi-method recruitment campaign will be implemented, utilizing both electronic health record (EHR)-informed and community-based strategies. A sub-study will be conducted to understand the effectiveness of EHR-informed recruitment. This sub-study will randomly assign a subsample of individuals identified in the EHR to one of three outreach modalities: patient portal message, email, and postal mail. Enrollment yield will be calculated for each recruitment method, with logistic regression modeling estimating the odds of enrollment by recruitment outreach type, both overall and among different demographic groups.
Upon enrollment, participants will specify preferences for receiving text messages regarding heart health, research education, and study opportunities. Messaging will focus on cardiovascular health prevention, management strategies, and research processes, with the aim of fostering trust in research within the community. Pre-post surveys will be distributed to assess changes in clinical trial awareness, trust in medical research, and willingness to participate in trials at baseline, 6 months, and 12 months post-enrollment. Interaction terms will be used to evaluate differences in outcomes by race, ethnicity, and sex.
The process for matching participants to research within the CONNECT project involves individual researchers submitting requests to the CONNECT study team for access to the learning community as a recruitment resource, followed by approval Institutional Review Board (IRB) approval. Upon access, researchers can retrieve, and view records of participants matched to respective studies, ensuring access only to data pertinent to the research objectives. Verification of IRB approval is mandated, and the CONNECT study team will request documentation from the individual research team's IRB to confirm compliance before granting access. Researchers using CONNECT must document eligibility and enrollment data for each CONNECT participant matched to the participants study. Proportions of participants matched to and enrolled in ongoing research studies will be tabulated and compared across demographic groups.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants enrolling in CONNECT will receive tailored educational text messages and opportunities to join cardiovascular research studies. Recruitment will occur via electronic health record (EHR)-informed and community-engaged methods. Enrollment yield will be evaluated for all outreach modalities, both overall and by priority populations (women and Black and Latino adults). The study will also assess participant trust in biomedical research, awareness of clinical trials, and willingness to participate at baseline, 6 months, and 12 months. Sub-study 1: This sub-study will evaluate the effectiveness of three EHR-informed outreach methods: patient portal message, email, and postal mail. Potentially eligible individuals will be identified through EHR query and randomly assigned to one of these methods. Enrollment yield will be assessed by outreach method and priority population.
| Arm | Type | Receives |
|---|---|---|
| Educational Text-Messages and Connection to Cardiovascular Research Opportunities | Experimental | Behavioral: Educational Text-Messages and Connection to Cardiovascular Research OpportunitiesAll participants who enroll in CONNECT, regardless of method of contact, will receive educational text messages and connection to cardiovascular research opportunities. |
| EHR-Informed Recruitment Sub-Study #1, Arm #1: Contact Method, Patient Portal Message | Active comparator | Behavioral: EHR-informed Recruitment Method of ContactPotential participants will be identified using an EHR query and will be randomized to receive a recruitment message via the patient portal message. This message will invite the participant to join CONNECT. |
| EHR-Informed Recruitment Sub-Study #1, Arm #2: Contact Method, Email | Active comparator | Behavioral: EHR-informed Recruitment Method of ContactPotential participants will be identified using an EHR query and will be randomized to receive a recruitment message via email. This message will invite the participant to join CONNECT. |
| EHR-Informed Recruitment Sub-Study #1, Arm #3: Contact Method, Postal Mail | Active comparator | Behavioral: EHR-informed Recruitment Method of ContactPotential participants will be identified using an EHR query and will be randomized to receive a recruitment message via postal mail. This message will invite the participant to join CONNECT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant is 18 years or older
- Residing in the US
- Self-identifies as having cardiovascular disease or cardiovascular risk factors
- Has a mobile phone and is willing to receive text-messages
- Can read in English or Spanish
Key exclusion criteria (1 listed)
- Unwilling or unable to provide informed consent
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 |
|---|---|---|
| EHR-informed Recruitment Method of ContactThe intervention being studied here is the method of contact (patient portal vs. email vs. postal mail) after being identified in the EHR | Behavioural | EHR-Informed Recruitment Sub-Study #1, Arm #1: Contact Method, Patient Portal Message, EHR-Informed Recruitment Sub-Study #1, Arm #2: Contact Method, Email, EHR-Informed Recruitment Sub-Study #1, Arm #3: Contact Method, Postal Mail |
| Educational Text-Messages and Connection to Cardiovascular Research OpportunitiesAll participants who enroll in CONNECT, regardless of method of contact, will receive educational text messages and connection to cardiovascular research opportunities. Text messages will be tailored and include content on cardiovascular health promotion and research participation. | Behavioural | Educational Text-Messages and Connection to Cardiovascular Research Opportunities |
Primary outcome
Participant accrual by priority population
Time frame: Baseline
The total number of participants enrolled in CONNECT, divided by the total number recruited. This will be completed for each recruitment method (EHR-Informed vs. Community-Engaged)
Participant accrual by recruitment method
Time frame: Baseline
The total number of participants enrolled in CONNECT, divided by the total number recruited. This will be completed for each priority population (women, Black, and Latino Adults).
4 secondary outcomes
Participant accrual in partnering cardiovascular research studies
Time frame: Baseline, 6-months, and 12-months
Trust in Biomedical Research using the Perceptions of Research Trustworthiness Scale (PoRT)
Time frame: Baseline, 6-months, and 12-months
Clinical trials awareness and knowledge will be assessed using items adapted from the Health Information National Trends Survey (HINTS)
Time frame: Baseline, 6-months, and 12-months
Willingness to participate in research will be measured by asking participants one related question
Time frame: Baseline, 6-months, and 12-months
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 6 Jan 2026.
- Derived from this study: PubMed 40792590Miller HN, Wong E, Byiringiro S, Hussain Z, Guerrero Vazquez M, Lewis-Land C, Skelton B, Curriero S, Foster A, Moghimi F, Tomiwa O, Shaia J, Sheikhattari P, Wang NY, Dennison Himmelfarb CR. CONNECT Platform to Increase Diverse Engagement and Enrollment in Cardiovascular Clinical Research: Rationale, Design, and Lessons Learned in Early Implementation. J Am Heart Assoc. 2025 Aug 19;14(16):e038351. doi: 10.1161/JAHA.124.038351. Epub 2025 Aug 12.
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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. This study is not recruiting at the moment.
Hailey N Miller, PhD, RN principal investigator
Johns Hopkins School of Nursing
Cheryl R Dennison Himmelfarb, PhD, RN, ANP principal investigator
Johns Hopkins School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EHR-informed Recruitment Method of Contact and Educational Text-Messages and Connection to Cardiovascular Research Opportunities in people with Cardiovascular Diseases and Hypertension, run by Johns Hopkins University 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 5 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 6 Jan 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant accrual by priority population (time frame: Baseline). 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 NCT06347484, which also lists 1 linked publication.
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 6 Jan 2026.