Stress Reduction Intervention for Women With Ischemic Heart Disease

Ischemic Heart Disease Clinical Trial

Official title:

Smartphone-delivered Stress Reduction Intervention for Women With Ischemic Heart Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02893579
• Other study ID #: 15-00650
• Status: Terminated
• Phase: N/A
• Start date: March 6, 2018
• Est. completion date: July 6, 2018

Study information

• Verified date: July 2018
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: July 6, 2018
• Est. primary completion date: July 6, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemia
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Behavioral:
• Early SR intervention
Self-directed stress reduction program delivered through a smart-phone application
• Delayed SR intervention
Activity tracking only for the first month

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	European Quality of Life- Five Dimensions (EQ-5D) scores		Change from Baseline to 3 Months