Voice Analysis Technology for Heart Attack Recovery

Overseen By Diana Albers

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Antidepressants

Disqualifiers: Cardiac transplant, Substance use, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

200 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to learn if a voice analysis smartphone app which detects anxiety and depression could be used along with cardiac rehabilitation to improve results compared to cardiac rehabilitation alone.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are actively treated for anxiety or depression with medication or therapy.

What data supports the effectiveness of the treatment Ellipsis Health Voice Application for heart attack recovery?

Research shows that mobile health tools, like interactive voice response and smartphone apps, can help manage cardiovascular diseases by improving lifestyle behaviors and medication adherence. These technologies have been beneficial in managing risk factors such as weight, smoking, and physical activity, which are important for heart health. ^{1 2 3 4 5}

How is the Voice Analysis Technology treatment for heart attack recovery different from other treatments?

This treatment is unique because it uses voice analysis technology to monitor heart attack recovery, which is noninvasive and can be done using a smartphone app. Unlike traditional methods that may require hospital visits or complex equipment, this approach allows for continuous monitoring and early detection of potential issues through voice changes. ^{6 7 8 9 10}

Research Team

Amir Lerman, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for heart attack survivors who own a smartphone, can use an app, and speak English. They must be diagnosed with myocardial infarction (MI) and starting cardiac rehab within 4 weeks of hospital discharge. It's not for pregnant individuals or those actively treated for anxiety or depression, nor patients with cardiac transplants, active substance use, neurocognitive disorders, psychosis, or mania.

Inclusion Criteria

Owns a smartphone

Willing to download and use a smartphone app

Able to read, write, and speak English

Exclusion Criteria

Neurocognitive disorder

Active psychosis

Active suicidality

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 12 weeks of cardiac rehabilitation, with one group using a voice analysis smartphone app to detect anxiety and depression

12 weeks

Follow-up

Participants are monitored for changes in health behaviors, quality of life, depressive symptoms, anxiety symptoms, and perceived stress

4 weeks

Treatment Details

Interventions

• Ellipsis Health Voice Application

Trial Overview The study tests if a voice analysis app on smartphones can help detect and manage depression and anxiety when used alongside traditional cardiac rehabilitation programs to improve patient outcomes compared to just the rehabilitation program alone.

Participant Groups

Group I: Cardiac rehabilitation plus voice analysis Experimental Treatment 1 Intervention

Subjects will complete 12 weeks of cardiac rehabilitation as per clinical care and utilize a voice analysis smartphone app.

Group II: Cardiac rehabilitation only Active Control 1 Intervention

Subjects will complete 12 weeks of cardiac rehabilitation as per clinical care.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

The Avatar application significantly improved knowledge, attitudes, and beliefs about Acute Coronary Syndrome (ACS) among 70 patients over a 6-month period, with notable differences in symptom knowledge and healthcare utilization compared to usual care.

Participants using the Avatar app were more likely to recognize symptoms and seek help, with 33.33% using an ambulance compared to 18.18% in the usual care group, indicating the app's effectiveness in enhancing confidence in responding to ACS symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of an Avatar application for teaching heart attack recognition and response: A pragmatic randomized control trial. Tongpeth, J., Du, H., Barry, T., et al.[2020]

The use of interactive voice response (IVR) technology significantly improved medication compliance and reduced adverse events in post-cardiac surgery patients, with a relative risk of 0.60 for the composite outcome of compliance and adverse events.

Patients who received IVR follow-up showed a remarkable reduction in medication non-compliance (relative risk of 0.34), and 93% of participants preferred this method of follow-up over no follow-up, indicating high acceptance of the technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using technology to create a medication safety net for cardiac surgery patients: a nurse-led randomized control trial. Sherrard, H., Struthers, C., Kearns, SA., et al.[2009]

Mobile applications and wearable sensors are increasingly being used to manage cardiovascular risk factors and improve treatment adherence, but their long-term benefits still need to be proven.

Daily home monitoring of pulmonary artery pressures using wireless sensors has been linked to a significant reduction in hospital readmissions for heart failure, highlighting the potential of technology to enhance patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A sneak peek into digital innovations and wearable sensors for cardiac monitoring. Michard, F.[2018]

Mobile health (mHealth) is significantly advancing cardiovascular care through innovative strategies like SMS for smoking cessation and apps for monitoring health, showing promise in prevention and rehabilitation.

Despite the potential of mHealth, many apps lack regulation and evidence-based support, highlighting the need for robust systems to ensure safety and effectiveness in delivering healthcare services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mHealth in Cardiovascular Health Care. Chow, CK., Ariyarathna, N., Islam, SM., et al.[2022]

Mobile health (mHealth) tools, such as interactive voice response and text messaging, have been shown to effectively improve lifestyle behaviors and management of cardiovascular diseases, particularly in low- and middle-income countries, based on a comprehensive review of studies since 2004.

These interventions can enhance preventive care by addressing key risk factors like weight, smoking, and physical activity, and have also demonstrated benefits in managing hypertension and improving medication adherence, suggesting they are a feasible option for improving health outcomes globally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Health Devices as Tools for Worldwide Cardiovascular Risk Reduction and Disease Management. Piette, JD., List, J., Rana, GK., et al.[2023]

A smartphone-based ECG analyzer (QCG™) demonstrated superior performance in detecting ST-elevation myocardial infarction (STEMI) compared to human experts, with an AUC-ROC of 0.919 versus 0.856 for all clinicians.

The AI system's accuracy remained consistent across various image acquisition conditions, indicating its robustness and reliability in diagnosing STEMI regardless of how the ECG images were captured.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Artificial intelligence versus physicians on interpretation of printed ECG images: Diagnostic performance of ST-elevation myocardial infarction on electrocardiography. Choi, YJ., Park, MJ., Ko, Y., et al.[2022]

A smartphone app has been developed to monitor patients' heart conditions, providing real-time data and alerts for potential risks.

Nurses have reported positive feedback on the app's effectiveness in enhancing patient care and early detection of heart-related issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New app could help cardiac patients manage condition and avert a crisis. Longhurst, C.[2017]

The Q-Voz application, designed for voice therapy, received positive feedback from seven speech therapists, who found it useful for helping patients with dysphonia improve their voice-related habits.

All evaluators agreed that the app could facilitate easier changes in voice behavior for patients, suggesting it can be an effective auxiliary tool in voice rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prototype app for voice therapy: a peer review. Lavaissiéri, P., Melo, PE.[2022]

Vox4Health, an m-health system, demonstrated a detection accuracy of 72.6% for voice disorders using acoustic measures, with jitter providing the highest sensitivity at 96%.

When enhanced with machine learning techniques, Vox4Health improved its accuracy to 77.4%, indicating its potential as a reliable screening tool for voice disorders in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Voice Disorder Detection via an m-Health System: Design and Results of a Clinical Study to Evaluate Vox4Health. Cesari, U., De Pietro, G., Marciano, E., et al.[2022]

Seven out of eight studies reviewed found that smartphone voice analyzer applications can provide assessments comparable to traditional techniques for managing voice disorders.

Despite promising results, there are still challenges to address, such as inconsistencies in voice parameters, types of voice pathologies tested, and variations in smartphone software and microphone quality before these applications can be widely adopted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Current State and Future Possibilities of Mobile Phone "Voice Analyser" Applications, in Relation to Otorhinolaryngology. Munnings, AJ.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Effectiveness of an Avatar application for teaching heart attack recognition and response: A pragmatic randomized control trial. [2020]

2. Canada pubmed.ncbi.nlm.nih.gov

Using technology to create a medication safety net for cardiac surgery patients: a nurse-led randomized control trial. [2009]

3. Netherlands pubmed.ncbi.nlm.nih.gov

A sneak peek into digital innovations and wearable sensors for cardiac monitoring. [2018]

4. Australia pubmed.ncbi.nlm.nih.gov

mHealth in Cardiovascular Health Care. [2022]

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

Mobile Health Devices as Tools for Worldwide Cardiovascular Risk Reduction and Disease Management. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Artificial intelligence versus physicians on interpretation of printed ECG images: Diagnostic performance of ST-elevation myocardial infarction on electrocardiography. [2022]

7. England pubmed.ncbi.nlm.nih.gov

New app could help cardiac patients manage condition and avert a crisis. [2017]

8. Brazil pubmed.ncbi.nlm.nih.gov

Prototype app for voice therapy: a peer review. [2022]

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

Voice Disorder Detection via an m-Health System: Design and Results of a Clinical Study to Evaluate Vox4Health. [2022]

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

The Current State and Future Possibilities of Mobile Phone "Voice Analyser" Applications, in Relation to Otorhinolaryngology. [2021]