Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT) (CONNECT)

January 5, 2026 updated by: Johns Hopkins University

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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:

  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.

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University School of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Unwilling or unable to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.
Active Comparator: 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.
Behavioral: 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
Active Comparator: 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.
Behavioral: 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
Active Comparator: 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.
Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline
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).
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant accrual in partnering cardiovascular research studies
Time Frame: Baseline, 6-months, and 12-months
The proportion of CONNECT participants who enroll into a cardiovascular research study.
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
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.
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
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."
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
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."
Baseline, 6-months, and 12-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

American Heart Association
Morgan State University

Investigators

  • Principal Investigator: Hailey N Miller, PhD, RN, Johns Hopkins School of Nursing
  • Principal Investigator: Cheryl R Dennison Himmelfarb, PhD, RN, ANP, Johns Hopkins School of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2024

Primary Completion (Actual)

December 31, 2025

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

March 29, 2024

First Submitted That Met QC Criteria

April 3, 2024

First Posted (Actual)

April 4, 2024

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00411716

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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