Clinical trial NCT06347484: Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Official title: Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Hypertension
Diabetes Type 2
Stroke
Recruitment
Overweight and Obesity
Hyperlipidemias
Keywords: Recruitment
Diversity
Inclusion
Clinical Trials
Cardiovascular Disease
Community Engagement
Registry
Digital Health
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Morgan State University
name: American Heart Association
First posted: 2024-04-04
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: OTHER

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Participant accrual by priority population
timeFrame: Baseline
measure: Participant accrual by recruitment method
timeFrame: Baseline
Secondary outcomes:
measure: Participant accrual in partnering cardiovascular research studies
timeFrame: Baseline, 6-months, and 12-months
measure: Trust in Biomedical Research using the Perceptions of Research Trustworthiness Scale (PoRT)
timeFrame: Baseline, 6-months, and 12-months
measure: Clinical trials awareness and knowledge will be assessed using items adapted from the Health Information National Trends Survey (HINTS)
timeFrame: Baseline, 6-months, and 12-months
measure: Willingness to participate in research will be measured by asking participants one related question
timeFrame: Baseline, 6-months, and 12-months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Nursing
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Nursing
name: Hailey N Miller, PhD, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins School of Nursing
name: Cheryl R Dennison Himmelfarb, PhD, RN, ANP
role: PRINCIPAL_INVESTIGATOR
References: