Telehealth Group Counseling for Cardiovascular Disease

Overseen By Krista Vadaketh, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: No ASCVD evidence

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

50 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to utilize an innovative healthcare delivery strategy via telehealth group counseling sessions to improve engagement, adherence, and ultimately outcomes in female patients with atherosclerotic cardiovascular disease (ASCVD).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Telehealth Group Counseling for Cardiovascular Disease?

Research shows that telehealth counseling can help people at high risk for heart problems improve their exercise and diet habits more than just getting brief advice. It also helps lower blood pressure, which is important for heart health. ^{1 2 3 4 5}

Is telehealth group counseling safe for humans?

Telehealth group counseling, also known as online or virtual group therapy, has been used safely in various studies for different conditions, including heart failure and HIV. While technical challenges can occur, they do not pose a safety risk to participants. ^{5 6 7 8 9}

How is Telehealth Group Counseling different from other treatments for cardiovascular disease?

Telehealth Group Counseling is unique because it uses online group sessions to help patients make lifestyle changes, such as improving diet and exercise, which can lead to better heart health. This approach is more interactive and supportive than traditional brief counseling, and it can be accessed from home, making it convenient for patients. ^{1 5 10 11 12}

Research Team

Diala Steitieh, MD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

This trial is for women with various heart conditions such as heart attack, angina, and coronary artery disease. Participants should have atherosclerotic cardiovascular disease (ASCVD) and be interested in joining group counseling sessions via telehealth to improve their health management.

Inclusion Criteria

I am a woman aged 18 or older.

Patients managed by providers at the Weill Cornell Medicine Women's Heart Program

I am a woman with heart disease or related conditions like chest pain, heart attack, high blood pressure, high cholesterol, diabetes, or palpitations.

Exclusion Criteria

I am a woman with risk factors like high blood pressure but no heart disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Telehealth Counseling

Participants engage in telehealth group counseling sessions to improve engagement and adherence in managing ASCVD

12 weeks

1-5 sessions (virtual)

Follow-up

Participants are monitored for changes in medication compliance, accessibility to care, understanding of disease, and overall satisfaction

4 weeks

Treatment Details

Interventions

• Telehealth Group Counseling

Trial Overview The study is testing the effectiveness of group counseling sessions conducted through telehealth as a way to help female patients better manage their heart conditions and adhere to treatment plans.

Participant Groups

Group I: Telehealth Counseling Experimental Treatment 1 Intervention

Telehealth sessions

Telehealth Group Counseling is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Telehealth Group Counseling for:

• Mental health support
• Substance abuse counseling
• Chronic health conditions management
• Cardiovascular disease management

Approved in European Union as Telehealth Group Therapy for:

• Anxiety disorders
• Depression
• Chronic illnesses management
• Preventive care

Approved in Canada as Virtual Group Therapy for:

• Mental health support
• Addiction counseling
• Chronic disease management

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Findings from Research

Telehealth counseling significantly improved adherence to exercise and dietary changes in high-risk cardiovascular patients compared to standard brief preventive counseling, with notable increases in adherence rates after treatment and at 6-month follow-up.

Participants receiving telehealth counseling also experienced greater reductions in blood pressure, indicating that this method not only promotes lifestyle changes but may also enhance cardiovascular health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic benefit of preventive telehealth counseling in the Community Outreach Heart Health and Risk Reduction Trial. Nolan, RP., Upshur, RE., Lynn, H., et al.[2011]

In a study involving 264 participants aged 35 to 74 with hypertension, e-counseling significantly reduced systolic blood pressure by an average of 10.1 mm Hg compared to 6.0 mm Hg in the control group after 12 months, indicating its efficacy in hypertension management.

E-counseling also led to improvements in pulse pressure and cardiovascular risk, demonstrating that combining technology with structured behavioral counseling can enhance the effectiveness of standard medical treatments for hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of E-Counseling for Hypertension: REACH. Nolan, RP., Feldman, R., Dawes, M., et al.[2019]

In a study of 192 adults with an average BMI of 32.7, both computer-automated feedback and human e-mail counseling led to significantly greater weight loss at 3 months compared to no counseling, with similar results between the two counseling methods.

At 6 months, human e-mail counseling resulted in greater weight loss than computer-automated feedback, indicating that while automated feedback is effective, human interaction may enhance long-term weight loss outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial comparing human e-mail counseling, computer-automated tailored counseling, and no counseling in an Internet weight loss program. Tate, DF., Jackvony, EH., Wing, RR.[2022]

In a study of 431 patients with cardiovascular disease using a fourth-generation synchronous telehealth program, those with higher CHA2DS2-VASc scores (≥4) had a significantly lower risk of cardiovascular hospitalization compared to those not using the program (41.8% vs 61.5%).

The telehealth program was shown to be a significant factor in reducing hospitalization rates for patients with higher CHA2DS2-VASc scores, indicating that this approach may be particularly beneficial for patients at greater risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the CHA2DS2-VASc Score for Risk Stratification of Hospital Admissions Among Patients With Cardiovascular Diseases Receiving a Fourth-Generation Synchronous Telehealth Program: Retrospective Cohort Study. Lee, JK., Hung, CS., Huang, CC., et al.[2020]

In a study involving 231 patients with chronic heart failure, the automated e-counseling program did not significantly improve health-related quality of life as measured by the Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) compared to conventional education.

However, the e-counseling program led to greater engagement (more logon weeks, hours, and total logons) and positively influenced self-care behaviors and diet, suggesting it may still be beneficial for managing chronic heart failure despite not improving overall quality of life scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated E-Counseling for Chronic Heart Failure: CHF-CePPORT Trial. Nolan, RP., Ross, HJ., Farkouh, ME., et al.[2021]

The Y2TEC study, which involved about 500 video counseling sessions for young adults living with HIV, demonstrated that video-based counseling can be effective but is often hindered by technical challenges that affect appointment flow and satisfaction.

By identifying common technological issues and providing best practice recommendations, clinicians can significantly enhance the quality and effectiveness of their telehealth sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overcoming Technological Challenges: Lessons Learned from a Telehealth Counseling Study. Wootton, AR., McCuistian, C., Legnitto Packard, DA., et al.[2021]

A study involving 211 clients (105 receiving cybercounseling and 106 receiving in-person counseling) aimed to evaluate the effectiveness and client satisfaction of text-based e-mail counseling compared to traditional face-to-face therapy.

The research highlights the importance of understanding client preferences and outcomes in choosing between cybertherapy and in-person counseling, emphasizing ethical considerations and treatment suitability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of client characteristics in cyber and in-person counseling. Murphy, L., Mitchell, D., Hallett, R.[2011]

In a study of 40 hypertensive patients receiving counseling every three weeks for six months, both telephone and clinic visit counseling significantly reduced blood pressure, while a control group showed no change.

Telephone counseling was found to be more cost-effective than clinic visits, costing $39 per patient compared to $82 for clinic counseling, making it a viable option for managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The cost-effectiveness of telephone vs clinic counseling for hypertensive patients: a pilot study. Bertera, EM., Bertera, RL.[2019]

Telehealth interventions (THI) significantly reduce the incidence of cardiovascular disease (CVD) in patients with a history of CVD, with a relative risk reduction of 45% compared to usual care, based on a meta-analysis of 8 randomized controlled trials involving 1635 individuals.

In contrast, THI did not show a significant effect on CVD incidence in patients without a prior history of CVD, indicating that the benefits of THI may be more pronounced in those already at risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of telehealth interventions on major cardiovascular outcomes: a meta-analysis of randomized controlled trials. Gu, X., Zhu, Y., Zhang, Y., et al.[2020]

eHealth interventions can significantly support self-management in patients with chronic cardiovascular conditions, but their implementation faces challenges such as users' age, low technological literacy, and perceived depersonalization in care.

To enhance the effectiveness of eHealth interventions, it is crucial to provide digital education and support from family or friends, addressing barriers to technology access and usability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers and Supports in eHealth Implementation among People with Chronic Cardiovascular Ailments: Integrative Review. Herrera, S., Salazar, A., Nazar, G.[2022]

Telehealth has shown promise in improving the management of chronic cardiac disease, particularly by providing remote diagnosis and rehabilitation services, which can benefit patients in rural areas.

While telehealth may reduce costs in service delivery for cardiac care, further controlled trials are needed to establish its cost-effectiveness and solidify its role in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth and the diagnosis and management of cardiac disease. Hooper, GS., Yellowlees, P., Marwick, TH., et al.[2017]

Healthcare professionals (HCPs) see eHealth as a promising tool to help patients with cardiovascular diseases (CVD) adopt and maintain a healthy lifestyle, but they face challenges in using these digital tools effectively.

In-depth interviews with 16 Dutch HCPs revealed that while they recognize the benefits of eHealth, there are significant barriers to its adoption, suggesting that addressing these issues could enhance the integration of eHealth into patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitators of and Barriers to Lifestyle Support and eHealth Solutions: Interview Study Among Health Care Professionals Working in Cardiac Care. Cohen Rodrigues, TR., de Buisonjé, DR., Keesman, M., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Therapeutic benefit of preventive telehealth counseling in the Community Outreach Heart Health and Risk Reduction Trial. [2011]

2. United States pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of E-Counseling for Hypertension: REACH. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

A randomized trial comparing human e-mail counseling, computer-automated tailored counseling, and no counseling in an Internet weight loss program. [2022]

4. Canada pubmed.ncbi.nlm.nih.gov

Use of the CHA2DS2-VASc Score for Risk Stratification of Hospital Admissions Among Patients With Cardiovascular Diseases Receiving a Fourth-Generation Synchronous Telehealth Program: Retrospective Cohort Study. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Automated E-Counseling for Chronic Heart Failure: CHF-CePPORT Trial. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Overcoming Technological Challenges: Lessons Learned from a Telehealth Counseling Study. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

A comparison of client characteristics in cyber and in-person counseling. [2011]

8. United States pubmed.ncbi.nlm.nih.gov

The cost-effectiveness of telephone vs clinic counseling for hypertensive patients: a pilot study. [2019]

9. China pubmed.ncbi.nlm.nih.gov

Effect of telehealth interventions on major cardiovascular outcomes: a meta-analysis of randomized controlled trials. [2020]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Barriers and Supports in eHealth Implementation among People with Chronic Cardiovascular Ailments: Integrative Review. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Telehealth and the diagnosis and management of cardiac disease. [2017]

12. Canada pubmed.ncbi.nlm.nih.gov

Facilitators of and Barriers to Lifestyle Support and eHealth Solutions: Interview Study Among Health Care Professionals Working in Cardiac Care. [2021]