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were not able to find enough eligible patients. We recruited 6, with incomplete data on those participants.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Intervention | Experimental | Stress reduction intervention 1 time a month |
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| Delayed Intervention | Experimental | Wait list Control |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early SR intervention | Behavioral | Self-directed stress reduction program delivered through a smart-phone application |
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| Measure | Description | Time Frame |
|---|---|---|
| Seattle Angina Questionnaire [SAQ] | 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. | Change from Baseline to 3 Months |
| Rose Dyspnea Score | 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. | Change from Baseline to 3 Months |
| Patient Health Questionnaire [PHQ-2] | a 2-item screening tool for depression, which can be assessed further using the Patient Health Questionnaire-9 if positive | Change from Baseline to 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Duke Activity Status Index score | independently and incrementally predicts major adverse cardiac events (MACE) in patients post-MI as well as in those with chronic stable heart failure | Change from Baseline to 3 Months |
| European Quality of Life- Five Dimensions (EQ-5D) scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harmony Reynolds, MD | New York University Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
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| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Delayed SR intervention | Behavioral | Activity tracking only for the first month |
|
| Change from Baseline to 3 Months |