Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06347484
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-03-29
Brief Title:
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials CONNECT
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONNECT
Brief 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 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
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 teams 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
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 teams 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None