Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
NCT ID: NCT06347484
Last Updated: 2026-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
1000 participants
INTERVENTIONAL
2024-05-04
2026-10-31
Brief Summary
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Detailed Description
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1. Identifying best practices for research recruitment and engagement among women and Black and Latino adults.
2. Increasing participation in cardiovascular health research among women and Black and Latino adults.
3. 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
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
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.
OTHER
NONE
Study Groups
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Educational Text-Messages and Connection to Cardiovascular Research Opportunities
All participants who enroll in CONNECT, regardless of method of contact, will receive educational text messages and connection to cardiovascular research opportunities.
Educational Text-Messages and Connection to Cardiovascular Research Opportunities
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.
EHR-Informed Recruitment Sub-Study #1, Arm #1: Contact Method, Patient Portal Message
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.
EHR-informed Recruitment Method of Contact
The intervention being studied here is the method of contact (patient portal vs. email vs. postal mail) after being identified in the EHR
EHR-Informed Recruitment Sub-Study #1, Arm #2: Contact Method, Email
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.
EHR-informed Recruitment Method of Contact
The intervention being studied here is the method of contact (patient portal vs. email vs. postal mail) after being identified in the EHR
EHR-Informed Recruitment Sub-Study #1, Arm #3: Contact Method, Postal Mail
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.
EHR-informed Recruitment Method of Contact
The intervention being studied here is the method of contact (patient portal vs. email vs. postal mail) after being identified in the EHR
Interventions
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EHR-informed Recruitment Method of Contact
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 Opportunities
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Morgan State University
OTHER
American Heart Association
OTHER
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Hailey N Miller, PhD, RN
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins School of Nursing
Cheryl R Dennison Himmelfarb, PhD, RN, ANP
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins School of Nursing
Locations
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Johns Hopkins University School of Nursing
Baltimore, Maryland, United States
Countries
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References
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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.
Other Identifiers
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IRB00411716
Identifier Type: -
Identifier Source: org_study_id
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