Smartphone-delivered Stress Reduction Intervention for Women With Ischemic Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Seattle Angina Questionnaire [SAQ]
研究概览
简要总结
This is a single center, randomized controlled trial which will include women with ischemic heart disease to receive either a self-directed stress reduction program delivered through a smart-phone application or activity tracking only for the first month ("early SR intervention" and "delayed SR intervention", respectively). Patients will be monitored for 1 month for application use and step counts via telephone or email interview and/or collection of screen-captured data. Baseline questionnaires will be repeated at the end of one month to assess for all primary and secondary measures, at which time the control group (activity tracking only) will be introduced to the intervention program. The early SR intervention group will not receive a new intervention but will be encouraged to continue using the app. Data will be collected for an additional 2 months with all participants in both groups. After the three-month study period, the study will close with the collection of final questionnaire data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Presence of ischemic heart disease as defined by one or more of the following within the last 2 years:
- •Positive stress test
- •Admission for ACS, PCI, or CABG
- •Typical or atypical ischemic symptoms within one month of enrollment
- •On stable dose of anti-anginal medications for at least 2 months
- •Able and willing to provide informed consent and comply with all aspects of the protocol
- •Owns a smartphone with the ability to download applications for stress reduction and activity tracking
- •English-speaking (apps are not available in other languages)
排除标准
- •Planned for revascularization during the study period
- •Self-reported or chart-reviewed diagnosis of psychotic disorder including schizophrenia or schizoaffective disorder, bipolar disorder
- •Current participation in a cardiac rehab program or planned participation during the study period
研究组 & 干预措施
Early Intervention
Stress reduction intervention 1 time a month
干预措施: Early SR intervention (Behavioral)
Delayed Intervention
Wait list Control
干预措施: Delayed SR intervention (Behavioral)
结局指标
主要结局
Seattle Angina Questionnaire [SAQ]
时间窗: Change from Baseline to 3 Months
The Seattle Angina Questionnaire is a well-validated descriptive instrument for measuring quality of life across five dimensions of coronary artery disease: physical limitation, anginal stability, anginal frequency, treatment satisfaction and disease perception. 45 Patient SAQ scores have been found to be independently prognostic of subsequent mortality, hospitalization, and resource use.
Rose Dyspnea Score
时间窗: Change from Baseline to 3 Months
The Rose Dyspnea Score provides additional information about patient dyspnea, which is a common complaint in patients with IHD independent of the presence of heart failure.
Patient Health Questionnaire [PHQ-2]
时间窗: Change from Baseline to 3 Months
a 2-item screening tool for depression, which can be assessed further using the Patient Health Questionnaire-9 if positive
次要结局
- Duke Activity Status Index score(Change from Baseline to 3 Months)
- European Quality of Life- Five Dimensions (EQ-5D) scores(Change from Baseline to 3 Months)