Educational Messages for Cardiovascular Disease

(CONNECT Trial)

Overseen By Foujan Moghimi, MS, CCRP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Unwilling or unable to consent

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to boost diversity in cardiovascular research by providing targeted educational messages to women and Black and Latino adults with cardiovascular disease or risk factors. Participants will receive text messages about heart health and research participation for a year and may connect to other research opportunities based on their interests. The study will test different contact methods, such as email, postal mail, and patient portal messages, to determine which is most effective at reaching potential participants. Individuals with heart disease or risk factors and a mobile phone might be a good fit for this trial.

As an unphased trial, this study offers a unique opportunity to contribute to important research that could improve heart health education and outreach for diverse communities.

Will I have to stop taking my current medications?

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

What prior data suggests that this educational platform is safe for participants?

Research shows that using text messages for health education is generally safe and well-received. In past studies, programs that sent educational and supportive text messages to patients helped them attend health programs more regularly and reduced their anxiety and depression. Another study found that text messaging had small but positive effects on lowering heart disease risk factors. These findings suggest that receiving educational text messages, like those in the CONNECT program, is unlikely to cause any serious side effects. The treatment involves educational messages, which are non-invasive and have not been linked to any harmful outcomes in similar studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CONNECT trial because it explores new ways to engage people with cardiovascular disease through educational text messages and by connecting them to research opportunities. Unlike traditional treatments that focus solely on medication or lifestyle changes, this approach emphasizes enhancing patient knowledge and involvement in their own health care. The trial also investigates different methods of reaching potential participants, such as email, postal mail, and patient portal messages, to determine the most effective way to engage and inform patients. This innovative strategy could lead to more personalized and proactive management of cardiovascular disease, potentially improving patient outcomes and participation in future research.

What evidence suggests that this trial's educational messages could be effective for cardiovascular disease?

This trial will evaluate the effectiveness of educational text messages in improving heart health. Studies have shown that text messages can help people remember to take their medication and lower their blood pressure, both crucial for reducing heart disease risk. Some research also indicates small improvements in cholesterol levels and other risk factors when messages focus on lifestyle changes. However, effects can vary, and some studies show no significant impact on preventing heart disease. Overall, sending educational text messages appears promising for improving heart health, but results can differ based on their use. Participants in this trial will receive educational text messages and access to cardiovascular research opportunities as part of the CONNECT program. ^{3 6 7 8 9}

Who Is on the Research Team?

Cheryl R Dennison Himmelfarb, PhD, RN, ANP

Principal Investigator

Johns Hopkins School of Nursing

Hailey N Miller, PhD, RN

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

Residing in the US

Self-identifies as having cardiovascular disease or cardiovascular risk factors

I have a mobile phone and agree to receive text messages.

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?

Group I: Educational Text-Messages and Connection to Cardiovascular Research Opportunities Experimental Treatment 1 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, Email Active Control 1 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 Mail Active Control 1 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 Message Active Control 1 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.

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A meta-analysis of controlled trials of cardiac patient education. Mullen, PD., Mains, DA., Velez, R.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A review of 19 randomized controlled trials on therapeutic patient education for heart failure revealed that while major elements of program descriptions were present, critical information such as patients' educational needs and evaluation methods were often missing.

Improving the precision of program descriptions in future studies could enhance the effectiveness of therapeutic patient education for heart failure patients, suggesting a need for standardized reporting formats.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic patient education in heart failure: do studies provide sufficient information about the educational programme? Albano, MG., Jourdain, P., De Andrade, V., et al.[2014]

Patients with coronary heart disease (CHD) often feel uncertain and anxious due to inadequate communication about how lifestyle changes can reduce their future risk of cardiac events, which can lead to disengagement from making those changes.

Effective health education and risk communication are crucial for motivating patients with CHD to adopt healthier lifestyles, highlighting the need for improvements in how this information is conveyed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' Experiences of Cardiovascular Health Education and Risk Communication: A Qualitative Synthesis. Mentrup, S., Harris, E., Gomersall, T., et al.[2020]

A study involving 67 patients with coronary artery disease identified that all information related to their condition was deemed important or very important by the patients, highlighting their need for effective communication.

Thirty educational templates were created and validated for mobile phone use, covering essential topics like heart function, nutrition, exercise, and treatment, with a high content validity ratio (CVR) of over 0.80, ensuring the information is reliable and relevant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secondary prevention in coronary artery disease: development and content validity of educational messages for mobile phones. Vieira, LV., Souza, VL., Barros, ALBL., et al.[2023]

Effective management of coronary heart disease (CHD) requires personalized, evidence-based education and support that considers individual patient needs and preferences, as highlighted by a scoping review of literature from 2000 to 2022.

Digital health strategies, such as text messaging programs and smartphone applications, can enhance patient education and support, but a flexible approach is necessary since there is no single method that works for all patients at every stage of their care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Information Needs and Communication Strategies for People with Coronary Heart Disease: A Scoping Review. Zwack, CC., Smith, C., Poulsen, V., et al.[2023]

A review of sildenafil citrate (Viagra) safety data revealed that while over 28,000 spontaneous reports were filed, many concerning cardiovascular events were unconfirmed and primarily submitted by non-healthcare professionals, suggesting potential over-reporting of risks.

In contrast, more rigorous data from pooled clinical trials and the International Men's Health Study showed that the rates of myocardial infarction and all-cause mortality for sildenafil were similar to those of a placebo, indicating that the initial safety concerns may not reflect the true risk profile of the drug.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating evidence from multiple sources to evaluate post-approval safety: an example of sildenafil citrate and cardiovascular events. Sobel, RE., Reynolds, RF.[2019]

A comprehensive multilingual patient education package, including SMS, videos, and workbooks, was developed to improve medication compliance and reduce stroke risk factors in patients with recent strokes, involving input from 355 stakeholders.

The educational materials were found to be highly understandable, with an average assessment score of over 95%, and no implementation issues were reported by patients or research coordinators after one month, indicating readiness for further testing in a randomized control trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Development of Structured Semi-interactive Stroke Prevention Package for Secondary Stroke Prevention. Kate, MP., Verma, SJ., Arora, D., et al.[2022]

A prospective patient registry for neurosurgical procedures, implemented in 2013, successfully captured data from 8226 patients across nearly 12,000 surgeries, highlighting its effectiveness in tracking complications over time.

The Clavien-Dindo grade (CDG) was validated as a reliable method for classifying complications, showing a clear correlation with patient outcomes such as performance status and length of hospital stay.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurosurgery outcomes and complications in a monocentric 7-year patient registry. Sarnthein, J., Staartjes, VE., Regli, L.[2022]

Despite a decrease in cardiovascular disease mortality over the past decade, the overall burden of cardiovascular disease remains significant, leading to increased hospitalizations and costs.

This systematic review aims to identify effective educational strategies for improving cardiovascular health education among hospitalized patients, highlighting the need for better understanding of what works best in patient education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient education strategies for hospitalized cardiovascular patients: a systematic review. Commodore-Mensah, Y., Himmelfarb, CR.[2018]

An integrative review of 15 articles found that educational technologies, particularly those implemented as year-long programs, significantly improved cardiovascular health outcomes in adults, including reductions in blood pressure and weight.

The most effective programs utilized playful technologies, such as storytelling and smartphone applications, leading to decreased hospitalizations and increased longevity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Educational technologies designed to promote cardiovascular health in adults: integrative review]. Souza, AC., Moreira, TM., Borges, JW.[2019]

The definition of an adverse drug event (ADE) should be tailored to the specific purpose of the evaluation, with stricter definitions needed for scientific studies and more flexible ones for clinical use.

Postmarketing safety data for drugs is limited at launch, but can be supplemented through systems like the FDA's Spontaneous Reporting System and targeted research projects, emphasizing the importance of robust epidemiological evidence for regulatory actions like drug recalls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug events: identification and attribution. Rogers, AS.[2022]

Between 2010 and 2016, 164 safety advisories regarding cardiac-related adverse events were issued by regulators in Australia, Canada, the UK, and the US, highlighting the prevalence of risks associated with 61 different drugs, primarily involving cardiac arrhythmias and coronary artery disorders.

While monitoring patients was the most common recommendation in these advisories, only 41.2% provided detailed guidance on how to conduct this monitoring, indicating a need for more consistent and comprehensive information for healthcare professionals and consumers regarding rare but serious medication harms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regulatory post-market drug safety advisories on cardiac harm: A comparison of four national regulatory agencies. Hooimeyer, A., Bhasale, A., Perry, L., et al.[2023]

A study involving 31 health professionals revealed significant gaps in knowledge and fear of punishment as major barriers to effectively reporting adverse events in a teaching hospital.

Improving communication and educational practices between leaders and healthcare professionals is essential to enhance the reporting of adverse events, which is crucial for patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The practice of reporting adverse events in a teaching hospital. Siman, AG., Cunha, SGS., Brito, MJM.[2019]

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Participants receive 12 months of tailored heart health and research text messages and are connected to CVD research that aligns with their interests. The ...

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Although some studies of text messaging interventions for CVD prevention have demonstrated effectiveness,20,29 other studies have found no effect on the ...

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The use of a lifestyle-focused text messaging service compared with usual care resulted in a modest improvement in LDL-C level and greater improvement in other ...

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We conducted a randomized controlled trial of tailored text messages with newly enrolled Medicaid managed care beneficiaries.