Myocardial Infarction
Conditions
Keywords
Cardiac Rehabilitation
Brief summary
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.
Interventions
DEVICEEllipsis Health Voice Application
Smartphone application that utilizes voice biomarkers to assess for potential presence and severity of depression and anxiety
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥ 18 years 2. Enrolled in cardiac rehabilitation program to start within 3 months from hospital discharge 3. Owns a smartphone 4. Willing to download and use a smartphone app 5. Able to read, write, and speak English
Exclusion criteria
1. Cardiac transplant 2. Active substance use 3. Neurocognitive disorder 4. Active psychosis 5. Mania diagnosis 6. Active suicidality 7. Uncontrolled bipolar disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in depressive symptoms | Baseline, 12 weeks | Measured using the self-reported Patient Health Questionnaire-9 (PHQ-9) to assess for major depressive disorder. Possible score range from 0 to 27, with higher scores indicating a worse outcome/greater severity of depressive symptoms. |
| Change in anxiety symptoms | Baseline, 12 weeks | Measured using the self-reported Generalized Anxiety Disorder 7-Item Scale (GAD-7) that assesses anxiety symptoms. Possible score range from 0 to 21, with higher scores indicating a worse outcome/greater severity of anxiety symptoms. |
| Change in perceived stress | Baseline, 12 weeks | Measured using the self-reported Perceived Stress Scale-14 (PSS-14), a 14 item questionnaire which assesses the degree to which situations in life are stressful within the last month. Each item is scored on a 5 point Likert scale from 0 (never) to 4 (very often), higher total scores indicate a worse outcome/greater severity of perceived stress. |
| Change in quality of life | Baseline, 12 weeks | Measured using the self-reported abbreviated generic Quality of Life Scale developed through the World Health Organization (WHOQOL-BREF) questionnaire that assesses an individual's perceptions of their health and well-being within the last two weeks. Each item is scored on a 5 point Likert scale, higher scores indicate greater perceived quality of life. |
| Change in health behaviors | Baseline, 12 weeks | Measured using the self-reported Current Health Behaviors (HB) questionnaire, a 13 item questionnaire which assesses behaviors and life circumstances during the last month. Each item is scored on a 10 point Likert scale, higher scores indicate better outcome. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORVirend Somers, MD, PhD
Mayo Clinic
Outcome results
None listed