Stress Reduction Intervention for Women With Ischemic Heart Disease

Not Applicable

Terminated

• Conditions: Ischemic Heart Disease
• Interventions: Behavioral: Early SR intervention; Behavioral: Delayed SR intervention

• Registration Number: NCT02893579
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-30
• Study First Submitted QC: 2016-09-02
• Study First Posted: 2016-09-08
• Study Start: 2018-03-06
• Status Verified: 2018-07
• Primary Completion: 2018-07-06
• Study Completion: 2018-07-06
• Last Update Submitted: 2018-07-17
• Last Update Posted: 2018-07-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 6

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Intervention	Early SR intervention	Stress reduction intervention 1 time a month
Delayed Intervention	Delayed SR intervention	Wait list Control

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States