Evaluation of Voice Analysis Technology in Detecting and Managing Depression and Anxiety in Patients Undergoing Cardiac Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in health behaviors
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled in cardiac rehabilitation program to start within 3 months from hospital discharge
- •Owns a smartphone
- •Willing to download and use a smartphone app
- •Able to read, write, and speak English
排除标准
- •Cardiac transplant
- •Active substance use
- •Neurocognitive disorder
- •Active psychosis
- •Mania diagnosis
- •Active suicidality
- •Uncontrolled bipolar disorder
研究组 & 干预措施
Cardiac rehabilitation plus voice analysis
Subjects will complete 12 weeks of cardiac rehabilitation as per clinical care and utilize a voice analysis smartphone app.
干预措施: Ellipsis Health Voice Application (Device)
Cardiac rehabilitation only
Subjects will complete 12 weeks of cardiac rehabilitation as per clinical care.
结局指标
主要结局
Change in health behaviors
时间窗: 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.
Change in anxiety symptoms
时间窗: 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 quality of life
时间窗: 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 depressive symptoms
时间窗: 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 perceived stress
时间窗: 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.
次要结局
未报告次要终点
研究者
Virend Somers, MD, PhD
Principal Investigator
Mayo Clinic