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

NCT06347484 | Active Not Recruiting

• 1 other identifier: IRB00411716
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Recruitment; Diversity; Inclusion; Clinical Trials; Cardiovascular Disease; Community Engagement; Registry; Digital Health

Outcome Measures

Primary Outcomes (2)

• Participant accrual by priority population

  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

  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 Outcomes (4)

• Participant accrual in partnering cardiovascular research studies

  Baseline, 6-months, and 12-months

• Trust in Biomedical Research using the Perceptions of Research Trustworthiness Scale (PoRT)

  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)

  Baseline, 6-months, and 12-months

• Willingness to participate in research will be measured by asking participants one related question

  Baseline, 6-months, and 12-months

Study Arms (4)

Educational Text-Messages and Connection to Cardiovascular Research Opportunities

EXPERIMENTAL

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

EHR-Informed Recruitment Sub-Study #1, Arm #1: Contact Method, Patient Portal Message

ACTIVE COMPARATOR

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

EHR-Informed Recruitment Sub-Study #1, Arm #2: Contact Method, Email

ACTIVE COMPARATOR

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

EHR-Informed Recruitment Sub-Study #1, Arm #3: Contact Method, Postal Mail

ACTIVE COMPARATOR

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

Interventions

Educational Text-Messages and Connection to Cardiovascular Research Opportunities BEHAVIORAL

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.

Educational Text-Messages and Connection to Cardiovascular Research Opportunities

EHR-informed Recruitment Method of Contact BEHAVIORAL

The intervention being studied here is the method of contact (patient portal vs. email vs. postal mail) after being identified in the EHR

EHR-Informed Recruitment Sub-Study #1, Arm #1: Contact Method, Patient Portal Message; EHR-Informed Recruitment Sub-Study #1, Arm #2: Contact Method, Email; EHR-Informed Recruitment Sub-Study #1, Arm #3: Contact Method, Postal Mail

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unwilling or unable to provide informed consent

Sponsors & Collaborators

• Johns Hopkins University: lead
• Morgan State University: collaborator
• American Heart Association: collaborator

Study Sites (1)

Johns Hopkins University School of Nursing

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

• Miller HN, Wong E, Byiringiro S, Hussain Z, Guerrero Vazquez M, Lewis-Land C, Skelton B, Curriero S, Foster A, Moghimi F, Tomiwa O, Shaia J, Sheikhattari P, Wang NY, Dennison Himmelfarb CR. CONNECT Platform to Increase Diverse Engagement and Enrollment in Cardiovascular Clinical Research: Rationale, Design, and Lessons Learned in Early Implementation. J Am Heart Assoc. 2025 Aug 19;14(16):e038351. doi: 10.1161/JAHA.124.038351. Epub 2025 Aug 12.

  PMID: 40792590 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Hypertension; Diabetes Mellitus, Type 2; Stroke; Overweight; Obesity; Hyperlipidemias

Condition Hierarchy (Ancestors)

Vascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyslipidemias; Lipid Metabolism Disorders

Study Officials

• Hailey N Miller, PhD, RN

  Johns Hopkins School of Nursing

  PRINCIPAL INVESTIGATOR

• Cheryl R Dennison Himmelfarb, PhD, RN, ANP

  Johns Hopkins School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 4, 2024
• Study Start: May 4, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 6, 2026

Record last verified: 2026-01

Locations

US (1)