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

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.

Conditions

• Cardiovascular Diseases
• Hypertension
• Diabetes Type 2
• Stroke
• Recruitment
• Overweight and Obesity
• Hyperlipidemias

Interventions

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

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.

Sponsors & Collaborators

• Morgan State University

  collaborator OTHER

• American Heart Association

  collaborator OTHER

• Johns Hopkins University

  lead OTHER

Principal Investigators

• Hailey N Miller, PhD, RN · Johns Hopkins School of Nursing

• Cheryl R Dennison Himmelfarb, PhD, RN, ANP · Johns Hopkins School of Nursing

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-05-04

Primary Completion

2025-12-31

Completion

2026-10-31

Countries

• United States

Study Locations