Ischemic Heart Disease
Conditions
Brief summary
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.
Interventions
BEHAVIORALEarly SR intervention
Self-directed stress reduction program delivered through a smart-phone application
BEHAVIORALDelayed SR intervention
Activity tracking only for the first month
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seattle Angina Questionnaire [SAQ] | 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 | 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] | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duke Activity Status Index score | Change from Baseline to 3 Months | independently and incrementally predicts major adverse cardiac events (MACE) in patients post-MI as well as in those with chronic stable heart failure |
| European Quality of Life- Five Dimensions (EQ-5D) scores | Change from Baseline to 3 Months | — |
Countries
United States
Outcome results
None listed