Clinical trial NCT02893579: Stress Reduction Intervention for Women With Ischemic Heart Disease
Official title: Smartphone-delivered Stress Reduction Intervention for Women With Ischemic Heart Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ischemic Heart Disease
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 6
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Seattle Angina Questionnaire [SAQ]
timeFrame: Change from Baseline to 3 Months
measure: Rose Dyspnea Score
timeFrame: Change from Baseline to 3 Months
measure: Patient Health Questionnaire [PHQ-2]
timeFrame: Change from Baseline to 3 Months
Secondary outcomes:
measure: Duke Activity Status Index score
timeFrame: Change from Baseline to 3 Months
measure: European Quality of Life- Five Dimensions (EQ-5D) scores
timeFrame: Change from Baseline to 3 Months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Harmony Reynolds, MD
role: PRINCIPAL_INVESTIGATOR
References: