Stress Reduction Intervention for Women With Ischemic Heart Disease

NCT02893579 | Terminated

• 1 other identifier: 15-00650
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Heart Disease

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (2)

• Duke Activity Status Index score

  Change from Baseline to 3 Months

• European Quality of Life- Five Dimensions (EQ-5D) scores

  Change from Baseline to 3 Months

Study Arms (2)

Early Intervention

EXPERIMENTAL

Stress reduction intervention 1 time a month

Behavioral: Early SR intervention

Delayed Intervention

EXPERIMENTAL

Wait list Control

Behavioral: Delayed SR intervention

Interventions

Early SR intervention BEHAVIORAL

Self-directed stress reduction program delivered through a smart-phone application

Early Intervention

Delayed SR intervention BEHAVIORAL

Activity tracking only for the first month

Delayed Intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Harmony Reynolds, MD

  New York University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: September 8, 2016
• Study Start: March 6, 2018
• Primary Completion: July 6, 2018
• Study Completion: July 6, 2018
• Last Updated: July 19, 2018

Record last verified: 2018-07

Locations

US (1)