Digital Heart Health Program for Heart Disease

(CHEAP Trial)

Overseen By John L Sievenpiper, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Toronto

Must be taking: Statins

Disqualifiers: Severe liver disease, Drug abuse, others

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

Compensation: Varies

Number of Visits: 16

Duration: 1 year

1100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding a digital heart health program to regular medical care can better manage heart disease. The research aims to determine if this digital tool helps lower cholesterol and reduces heart problems over time. Participants will be divided into two groups: one will use the digital program along with their standard care, while the other will continue with just standard care. Potential participants include those taking medication for heart-related issues, such as cholesterol, who have conditions like heart disease or diabetes, and can access online resources. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance heart health management.

Will I have to stop taking my current medications?

The trial does not specify that you need to stop taking your current medications. In fact, participants must be on a stable dose of their medications for at least 3 months before joining the study.

What prior data suggests that this digital heart health program is safe for heart disease patients?

Research has shown that digital tools like mobile apps for heart health are generally safe. These tools track heart health and offer real-time advice. For instance, a small study found that users found a heart health app easy to use and enjoyable.

Digital health apps are popular due to their convenience and simplicity. They enable users to monitor heart health and make healthier lifestyle choices. Unlike medications, they typically lack side effects, making them a low-risk option for improving heart health.

However, these apps should complement regular medical care. Always consult a healthcare provider before making significant changes to a health routine. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Digital Heart Health Program because it aims to enhance traditional heart disease treatments by integrating digital technology. Unlike the standard care options, which typically involve medication and lifestyle changes, this program leverages digital tools to provide personalized health monitoring and support. This approach has the potential to improve patient engagement and adherence to treatment plans, offering a more tailored and proactive method to manage heart disease. By using technology to complement existing treatments, the program hopes to lead to better health outcomes and a more efficient healthcare experience for patients.

What evidence suggests that the Digital Heart Health Program is effective for heart disease?

Studies have shown that digital healthcare can greatly improve outcomes for heart disease patients. Research indicates that digital tools can lower death rates and reduce the occurrence of disease in people with coronary artery disease. Additionally, digital programs have effectively boosted people's confidence in managing their heart health. Reviews of multiple studies have also shown that digital health tools can help prevent hospital visits due to heart failure. While researchers continue to explore the long-term benefits, these early findings suggest that digital health programs, such as the Digital Heart Health Program being tested in this trial, can be very helpful in managing heart disease. Participants in this trial will receive either the Digital Heart Health Program alongside standard care or standard care alone. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with heart-related conditions such as dyslipidemia and high cholesterol. Participants should be willing to use a digital health app, attend online sessions, complete questionnaires, and undergo blood work. Those who cannot commit to the study duration or follow-up requirements may not be eligible.

Inclusion Criteria

I've been on a stable dose of my cholesterol, diabetes, blood pressure, and weight loss medications for at least 3 months.

Fall under either of the 2 categories: Secondary prevention participants or High-risk primary prevention participants

I have been on a stable dose of statin for at least 3 months.

Exclusion Criteria

I have a severe liver condition.

I have a condition that affects how my body absorbs nutrients.

I have severe heart failure (NYHA class IV).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a digital heart health program + standard of care or standard of care alone. The digital program includes using a heart health app and attending 16 online sessions over the first year.

1 year

16 online sessions, 3 in-person visits for blood work and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, with continued use of the heart health app and regular assessments.

6 years

Annual online questionnaires and blood work every four years

Cohort Study

After the 7-year intervention phase, the study transitions to a cohort study where participants continue using the heart health app and complete regular assessments.

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Digital Heart Health Program

Trial Overview The study tests if adding a digital heart health program to standard care can better reduce cholesterol levels and cardiovascular risks over one year compared to standard care alone. It also examines long-term effects on major cardiovascular events up to seven years.

How Is the Trial Designed?

Group I: Digital Heart Health Program + Standard of Care Experimental Treatment 1 Intervention

Group II: Standard of Care Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials

739

Recruited

1,125,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

The Minnesota Heart Health Program is a comprehensive ten-year initiative aimed at preventing coronary heart disease through community-wide efforts, including systematic hypertension screening and educational programs.

By implementing multiple strategies across different sites and conducting annual surveys, the program aims to gather evidence on the effectiveness of these prevention methods in reducing heart disease risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prevention and treatment of hypertension at the population level: the Minnesota Heart Health Program]. Murray, D., Luepker, R., Grimm, R., et al.[2017]

Therapeutic education programs delivered through digital health significantly enhance patient knowledge and self-care in heart failure patients, as evidenced by a systematic review of 8 randomized clinical trials from 6 countries.

These programs also contribute to a reduction in hospital readmissions and improvements in functional status, highlighting their effectiveness as a complementary tool to traditional nursing care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Education interventions in heart failure using m-Health: Systematic review]. Camino Ortega, E., Baroja Gil de Gómez, A., González Gamarra, A., et al.[2023]

Digital health interventions (DHIs) showed an inconclusive effect on reducing cardiovascular disease (CVD) risk scores compared to usual care, based on a review of 6 randomized controlled trials involving 2,284 patients.

Among the different DHI modalities, automated email messaging appeared to be the most effective in improving CVD risk outcomes, although the overall evidence remains uncertain due to substantial variability in study results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital health RCT interventions for cardiovascular disease risk reduction: a systematic review and meta-analysis. Devani, RN., Kirubakaran, A., Molokhia, M.[2022]

Digital health interventions (DHI) significantly reduced all-cause mortality (8.5% vs. 10.2%) and cardiovascular mortality (7.3% vs. 9.6%) in patients with a history of heart failure hospitalization, based on a review of 10 trials involving 7204 patients over an average follow-up of 15.6 months.

While DHI did not significantly decrease overall hospitalizations for heart failure or all causes, patients using DHI experienced fewer days lost due to heart failure-related hospitalizations, indicating a potential benefit in managing heart failure symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital health intervention in patients with recent hospitalization for acute heart failure: A systematic review and meta-analysis of randomized trials. Elbadawi, A., Tan, BE., Assaf, Y., et al.[2022]

A pilot study involving 71 heart failure patients demonstrated that using a smartphone app and wearables for 3 months led to stable or improved clinical status, as indicated by the New York Heart Association class.

While most health indicators showed positive trends, such as improvements in walking distance and self-care behaviors, these changes were not statistically significant, suggesting that while the app-based intervention may be beneficial, further research is needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supporting patients with heart failure with digital therapeutics-A pilot study in Germany. Reif, S., Schubert, S., Stiefel, J., et al.[2023]

Citations

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Equitable access to digital technologies may help improve ... However, there is limited evidence of long-term engagement and effectiveness for technology-based nutrition programs.

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Digital health technology in the prevention of heart failure ... Multiple meta-analyses have demonstrated benefits of digital health on the prevention of HF hospitalizations. A systematic review and meta-analysis in 2020 ...

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Evaluating a New Digital App–Based Program for Heart ... This pilot study evaluated the feasibility and acceptability of a fully digital AI-powered lifestyle change program called Lark Heart Health.

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Hello Heart: Cardiovascular Digital Health Program for ... We're the first app that helps you track your heart health and get real-time tips. It's a simple yet powerful tool anyone can use to manage their heart health.

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Role of Technology in Promoting Heart Healthy Behavior ... In this scientific statement, we examined the technology-enabled interventions that address cardiovascular health behaviors from adolescence to adulthood.