An interventional study of Early SR intervention and Delayed SR intervention in Ischemic Heart Disease, sponsored by NYU Langone Health. Terminated at 1 site in United States. Open to female participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2018-07-19.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment
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.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's enrollment of 6 is below the median of 100 across 1,778 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Stress reduction intervention 1 time a month
Behavioral: Early SR intervention
Wait list Control
Behavioral: Delayed SR intervention
Self-directed stress reduction program delivered through a smart-phone application
Activity tracking only for the first month
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.
Time frame: 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.
Time frame: 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
Time frame: Change from Baseline to 3 Months
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
Time frame: Change from Baseline to 3 Months
European Quality of Life- Five Dimensions (EQ-5D) scores
Time frame: Change from Baseline to 3 Months
This study is terminated, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
NYU Langone Health