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

Trial Summary

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 data supports the effectiveness of the Digital Heart Health Program treatment for heart disease?

Research shows that digital health tools can improve the quality of life for heart failure patients by helping them take better care of themselves and stay engaged with their health. These tools can also provide continuous monitoring and targeted advice, which can lead to better health outcomes. ^{1 2 3 4 5}

Is the Digital Heart Health Program safe for humans?

The research on digital health interventions for heart disease, including programs like the Digital Heart Health Program, generally focuses on their effectiveness rather than safety. However, these interventions are typically non-invasive and involve digital tools like smartphone apps or online support, which are generally considered safe for human use. ^{1 5 6 7 8}

How is the Digital Heart Health Program treatment different from other heart disease treatments?

The Digital Heart Health Program is unique because it uses digital health interventions to support heart disease management, focusing on lifestyle changes like diet and physical activity through online platforms. This approach is different from traditional treatments as it leverages technology to enhance patient education and engagement in their own care. ^{5 9 10 11 12}

What is the purpose of this trial?

Despite the availability of medications, many people around the world continue to live with long-term health problems like heart disease, stroke and diabetes. In Canada, heart disease is a leading cause of death. Managing these health issues can be done by changing diet and lifestyle. Specific ways of eating have been proven to improve risk for heart disease and stroke. However, because doctors often have limited time, nutrition education, and lack of tools for counseling patients on nutrition, they can often only provide minimal support to help patients make necessary lifestyle changes. Digital tools and mobile applications offer an opportunity to involve doctors and patients in delivering nutrition interventions. This approach has the potential to save time, provide education, and reduce healthcare costs. This study is being done to understand the effect of a digital heart health program added to standard of care, compared with standard of care alone on heart health. All eligible participants in this study will be randomized (determined by chance) to one of two possible interventions: 1) a digital heart health program + standard of care; 2) standard of care. Standard is care is defined as the best practice based on guidelines for the treatment of a condition. All participants will be followed for seven years and will be asked to complete online questionnaires and complete blood work at their nearest LifeLabs clinic, as well as wear a continuous glucose monitor and wrist actigraph (at 3 time points in the first year). In addition, participants randomized to the digital heart health program + standard of care will be expected to use the heart health app and join 16 online synchronous sessions over the first year. After seven years, the intervention phase of the study will end and the study will become a cohort study. All participants at the 7-year time point will be invited to use the heart health app. As part of the cohort study, participants will be asked to continue completing the same questionnaires online and completing bloodwork at their nearest LifeLabs every four years for the duration of their participation in the cohort study. The main questions this study aims to answer are: 1. Will a digital heart health program added to standard of care result in a clinically meaningful reduction in blood cholesterol and other risk factors after 1-year compared to standard of care alone? 2. Will a digital heart health program added to standard of care result in a reduction in major cardiovascular events after 7-years compared to standard of care alone? 3. Are the observed effects sustained beyond the 7-years of the intervention? We hypothesize that the digital heart health program added to standard of care will result in a clinically meaningful reduction in blood cholesterol and other risk factors for heart disease after 1-year and reduce major cardiovascular events after 7-years compared to standard of care alone.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Netherlands 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. [2022]

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

Impact of Digital Health Technology on Quality of Life in Patients With Heart Failure. [2023]

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

Pragmatic randomized trial assessing the impact of digital health technology on quality of life in patients with heart failure: Design, rationale and implementation. [2023]

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

Supporting patients with heart failure with digital therapeutics-A pilot study in Germany. [2023]

5. Spain pubmed.ncbi.nlm.nih.gov

[Education interventions in heart failure using m-Health: Systematic review]. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Digital health interventions for the prevention of cardiovascular disease: a systematic review and meta-analysis. [2018]

7. Germany pubmed.ncbi.nlm.nih.gov

Digital health RCT interventions for cardiovascular disease risk reduction: a systematic review and meta-analysis. [2022]

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

Designing and testing telehealth interventions to improve outcomes for cardiovascular patients. [2007]

9. Canada pubmed.ncbi.nlm.nih.gov

Dose-Response Effect of a Digital Health Intervention During Cardiac Rehabilitation: Subanalysis of Randomized Controlled Trial. [2020]

10. England pubmed.ncbi.nlm.nih.gov

ESC e-Cardiology Working Group Position Paper: Overcoming challenges in digital health implementation in cardiovascular medicine. [2020]

11. Canada pubmed.ncbi.nlm.nih.gov

Using the internet for life style changes in diet and physical activity: a feasibility study. [2018]

12. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Prevention and treatment of hypertension at the population level: the Minnesota Heart Health Program]. [2017]