Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06347484 |
| Other study ID # |
IRB00411716 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 2024 |
| Est. completion date |
October 2026 |
Study information
| Verified date |
April 2024 |
| Source |
Johns Hopkins University |
| Contact |
Cassie Lewis-Land, MS, CCRP |
| Phone |
433-927-8722 |
| Email |
clewis4[@]jhmi.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The CONNECT: "Developing a learning COmmunity to increase eNgagemeNt and Enrollment in
cardiovascular Clinical Trials" is comprehensive, participant-centered learning community
that provides tailored education on cardiovascular (CV) health and research participation;
connects community members to CV-related research; and disseminates CV-related study
findings. The overreaching goal of CONNECT is to improve participation of underrepresented
communities in CV research, including as women, Black adults, and Latino adults, through
increasing participants' clinical trial awareness, trust in biomedical research, and
willingness to participate in clinical trials. CONNECT will use digital and community-engaged
approaches to identify and recruit 1000 adults with cardiovascular disease or a
cardiovascular disease risk factor to join CONNECT. Participants who join CONNECT will
receive tailored educational information on CV health and research participation via text
message. Participants will also have the opportunity to be matched to ongoing CV research
studies based on basic demographic information and areas of interest. The educational
information will be sent to participants for 12 months. The investigators hypothesize that
CONNECT will increase participants' clinical trial awareness, trust, and willingness to
participate in clinical trials and that the proportion of Black and Latin adults and women
enrolled in trials that partner with CONNECT will be higher following the use of CONNECT for
recruitment.
Description:
The CONNECT project, titled "Developing a learning COmmunity to increase eNgagemeNt and
Enrollment in cardiovascular Clinical Trials," seeks to establish an online learning
community aimed at promoting cardiovascular (CV) wellness and fostering inclusive
participation in CV clinical trials and research. It encompasses three primary objectives:
raising awareness about CV health and research, increasing participation in CV health
research studies, and identifying best practices for CV research recruitment and engagement,
particularly among underrepresented communities such as women, Black adults, and Latino
adults.
A multi-method recruitment campaign will be implemented, utilizing both electronic health
record (EHR)-informed and community-based strategies. These recruitment methods will undergo
rigorous evaluation to identify the most effective practices for engaging underrepresented
communities. 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 opportunities. Messaging will focus on CV 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.
