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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02893579
Other study ID # 15-00650
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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