search
Back to results

Stress Reduction Intervention for Women With Ischemic Heart Disease

Primary Purpose

Ischemic Heart Disease

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early SR intervention
Delayed SR intervention
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Heart Disease

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Early Intervention

Delayed Intervention

Arm Description

Stress reduction intervention 1 time a month

Wait list Control

Outcomes

Primary Outcome Measures

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.
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.
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

Secondary Outcome Measures

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

Full Information

First Posted
August 30, 2016
Last Updated
July 17, 2018
Sponsor
NYU Langone Health
search

1. Study Identification

Unique Protocol Identification Number
NCT02893579
Brief Title
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

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
were not able to find enough eligible patients. We recruited 6, with incomplete data on those participants.
Study Start Date
March 6, 2018 (Actual)
Primary Completion Date
July 6, 2018 (Actual)
Study Completion Date
July 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early Intervention
Arm Type
Experimental
Arm Description
Stress reduction intervention 1 time a month
Arm Title
Delayed Intervention
Arm Type
Experimental
Arm Description
Wait list Control
Intervention Type
Behavioral
Intervention Name(s)
Early SR intervention
Intervention Description
Self-directed stress reduction program delivered through a smart-phone application
Intervention Type
Behavioral
Intervention Name(s)
Delayed SR intervention
Intervention Description
Activity tracking only for the first month
Primary Outcome Measure Information:
Title
Seattle Angina Questionnaire [SAQ]
Description
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.
Time Frame
Change from Baseline to 3 Months
Title
Rose Dyspnea Score
Description
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.
Time Frame
Change from Baseline to 3 Months
Title
Patient Health Questionnaire [PHQ-2]
Description
a 2-item screening tool for depression, which can be assessed further using the Patient Health Questionnaire-9 if positive
Time Frame
Change from Baseline to 3 Months
Secondary Outcome Measure Information:
Title
Duke Activity Status Index score
Description
independently and incrementally predicts major adverse cardiac events (MACE) in patients post-MI as well as in those with chronic stable heart failure
Time Frame
Change from Baseline to 3 Months
Title
European Quality of Life- Five Dimensions (EQ-5D) scores
Time Frame
Change from Baseline to 3 Months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harmony Reynolds, MD
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Stress Reduction Intervention for Women With Ischemic Heart Disease

We'll reach out to this number within 24 hrs