Stress Reduction Intervention for Women With Ischemic Heart Disease

• ClinicalTrials.gov Identifier: NCT02893579
• Recruitment Status: Terminated
• First Posted: September 8, 2016
• Last Update Posted: July 19, 2018
• Sponsor: NYU Langone Health
• Information provided by (Responsible Party): NYU Langone Health

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Ischemic Heart Disease	Behavioral: Early SR intervention; Behavioral: Delayed SR intervention	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 6 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Smartphone-delivered Stress Reduction Intervention for Women With Ischemic Heart Disease
• Actual Study Start Date: March 6, 2018
• Actual Primary Completion Date: July 6, 2018
• Actual Study Completion Date: July 6, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Early Intervention; Stress reduction intervention 1 time a month	Behavioral: Early SR intervention; Self-directed stress reduction program delivered through a smart-phone application
Experimental: Delayed Intervention; Wait list Control	Behavioral: Delayed SR intervention; Activity tracking only for the first month

Outcome Measures

Primary Outcome Measures :

1. Seattle Angina Questionnaire [SAQ] [ Time Frame: 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.
2. Rose Dyspnea Score [ Time Frame: 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.
3. Patient Health Questionnaire [PHQ-2] [ Time Frame: 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 :

1. Duke Activity Status Index score [ Time Frame: 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
2. European Quality of Life- Five Dimensions (EQ-5D) scores [ Time Frame: Change from Baseline to 3 Months ]

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, New York

New York University School of Medicine

New York, New York, United States, 10016

Sponsors and Collaborators

NYU Langone Health

Investigators

• Principal Investigator: Harmony Reynolds, MD; New York University Medical School

More Information

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT02893579
• Other Study ID Numbers: 15-00650
• First Posted: September 8, 2016
• Last Update Posted: July 19, 2018
• Last Verified: July 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Heart Diseases; Myocardial Ischemia; Coronary Artery Disease; Ischemia; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases