1000 Participants Needed

Educational Messages for Cardiovascular Disease

(CONNECT Trial)

FM
CL
Overseen ByCassie Lewis-Land, MS, CCRP
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Johns Hopkins University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is the treatment generally safe for humans?

Safety data for treatments can be limited when they first become available, but additional information is gathered over time through reports and studies. For example, safety advisories have been issued for various drugs regarding heart-related risks, and monitoring patients is often recommended to ensure safety.12345

How does the educational message treatment for cardiovascular disease differ from other treatments?

This treatment is unique because it focuses on delivering educational messages through mobile phones to help patients with coronary artery disease understand and manage their condition better. Unlike traditional treatments that may focus on medication or procedures, this approach emphasizes patient education and engagement through digital communication, which can be personalized and ongoing.678910

What data supports the effectiveness of the treatment CONNECT for cardiovascular disease?

Research shows that patient education programs can help improve outcomes like blood pressure, mortality, exercise, and diet in heart patients. These programs work best when they include feedback, personalization, and skills to help patients change their behavior.1112131415

Who Is on the Research Team?

HN

Hailey N Miller, PhD, RN

Principal Investigator

Johns Hopkins School of Nursing

CR

Cheryl R Dennison Himmelfarb, PhD, RN, ANP

Principal Investigator

Johns Hopkins School of Nursing

Are You a Good Fit for This Trial?

The CONNECT trial is for US residents aged 18 or older who can read English or Spanish, self-identify with cardiovascular disease or risk factors like Type 2 Diabetes, obesity, high blood pressure, stroke, and high cholesterol. They must own a mobile phone and be open to receiving text messages.

Inclusion Criteria

I have a mobile phone and agree to receive text messages.
Residing in the US
Self-identifies as having cardiovascular disease or cardiovascular risk factors
See 1 more

Exclusion Criteria

Unwilling or unable to provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Recruitment and Enrollment

Participants are recruited using EHR-informed and community-engaged approaches and enrolled into the CONNECT platform

Baseline
1 visit (virtual or in-person)

Educational Intervention

Participants receive tailored educational text messages on cardiovascular health and research participation for 12 months

12 months

Follow-up

Participants are monitored for changes in clinical trial awareness, trust, and willingness to participate in trials

12 months
3 surveys (at baseline, 6 months, and 12 months)

What Are the Treatments Tested in This Trial?

Interventions

  • CONNECT
Trial Overview CONNECT aims to boost participation in cardiovascular research among underrepresented groups by providing tailored educational messages about heart health and study involvement via text. It connects participants to relevant studies and shares findings over a year.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Active Control
Group I: Educational Text-Messages and Connection to Cardiovascular Research OpportunitiesExperimental Treatment1 Intervention
All participants who enroll in CONNECT, regardless of method of contact, will receive educational text messages and connection to cardiovascular research opportunities.
Group II: EHR-Informed Recruitment Sub-Study #1, Arm #2: Contact Method, EmailActive Control1 Intervention
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.
Group III: EHR-Informed Recruitment Sub-Study #1, Arm #3: Contact Method, Postal MailActive Control1 Intervention
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.
Group IV: EHR-Informed Recruitment Sub-Study #1, Arm #1: Contact Method, Patient Portal MessageActive Control1 Intervention
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

American Heart Association

Collaborator

Trials
352
Recruited
6,196,000+

Morgan State University

Collaborator

Trials
7
Recruited
5,600+

Published Research Related to This Trial

Therapeutic patient education is crucial for improving self-management in cardiovascular disease, with the most effective interventions being tailored to individual patient needs and incorporating multiple components.
The review highlights the importance of multidisciplinary approaches in patient education, suggesting that these strategies can enhance self-management outcomes for patients with cardiovascular conditions.
Evidence for Therapeutic Patient Education Interventions to Promote Cardiovascular Patient Self-Management: A Scientific Statement for Healthcare Professionals From the American Heart Association.Barnason, S., White-Williams, C., Rossi, LP., et al.[2018]
Cardiac patient education programs significantly improve important health outcomes such as blood pressure, mortality rates, exercise habits, and dietary choices, based on a meta-analysis of 28 controlled studies.
The effectiveness of these programs is enhanced when they adhere to educational principles like reinforcement, feedback, and individualization, rather than the type of communication channel used.
A meta-analysis of controlled trials of cardiac patient education.Mullen, PD., Mains, DA., Velez, R.[2019]
Both the usual care group (UCG) and the advanced care group (ACG) showed significant reductions in systolic and diastolic blood pressure after 6 months, indicating that regular medical care is effective for managing blood pressure in high-risk cardiovascular patients.
However, the additional support provided by the ACG, which included information and encouragement via email or letters, did not lead to further improvements in weight, BMI, waist circumference, or smoking status, suggesting that more sophisticated behavioral support may be needed to enhance patient self-management.
Effectiveness of a quality improvement intervention targeting cardiovascular risk factors: are patients responsive to information and encouragement by mail or post?Senesael, E., Borgermans, L., Van De Vijver, E., et al.[2021]

Citations

Evidence for Therapeutic Patient Education Interventions to Promote Cardiovascular Patient Self-Management: A Scientific Statement for Healthcare Professionals From the American Heart Association. [2018]
A meta-analysis of controlled trials of cardiac patient education. [2019]
Effectiveness of a quality improvement intervention targeting cardiovascular risk factors: are patients responsive to information and encouragement by mail or post? [2021]
Patient education strategies for hospitalized cardiovascular patients: a systematic review. [2018]
Therapeutic patient education in heart failure: do studies provide sufficient information about the educational programme? [2014]
Adverse drug events: identification and attribution. [2022]
Neurosurgery outcomes and complications in a monocentric 7-year patient registry. [2022]
Regulatory post-market drug safety advisories on cardiac harm: A comparison of four national regulatory agencies. [2023]
Integrating evidence from multiple sources to evaluate post-approval safety: an example of sildenafil citrate and cardiovascular events. [2019]
The practice of reporting adverse events in a teaching hospital. [2019]
[Educational technologies designed to promote cardiovascular health in adults: integrative review]. [2019]
12.United Statespubmed.ncbi.nlm.nih.gov
Patients' Experiences of Cardiovascular Health Education and Risk Communication: A Qualitative Synthesis. [2020]
Information Needs and Communication Strategies for People with Coronary Heart Disease: A Scoping Review. [2023]
Secondary prevention in coronary artery disease: development and content validity of educational messages for mobile phones. [2023]
Systematic Development of Structured Semi-interactive Stroke Prevention Package for Secondary Stroke Prevention. [2022]
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