Ischemic Heart DiseaseNCT02893579
Stress Reduction Intervention for Women With Ischemic Heart Disease
A study testing Early SR intervention and Delayed SR intervention in people with Ischemic Heart Disease, run by NYU Langone Health at 1 site in United States.
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"… Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- Early SR intervention and Delayed SR intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2018to 6 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Smartphone-delivered Stress Reduction Intervention for Women With Ischemic Heart Disease
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
- Being tested
- Early SR intervention, Delayed SR intervention
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early SR interventionBehavioural
Self-directed stress reduction program delivered through a smart-phone application
Delayed SR interventionBehavioural
Activity tracking only for the first month
| Study group | Role | What they receive |
|---|---|---|
| Early Intervention | Experimental | Stress reduction intervention 1 time a month Receives: Behavioral: Early SR intervention |
| Delayed Intervention | Experimental | Wait list Control Receives: Behavioral: Delayed SR intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: Change from Baseline to 3 Months
Secondary outcomes (2)
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
Measured: Change from Baseline to 3 Months
European Quality of Life- Five Dimensions (EQ-5D) scores
Measured: Change from Baseline to 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study start6 Mar 2018
- Primary completion6 Jul 2018
- Study completion6 Jul 2018
Why it stopped: were not able to find enough eligible patients. We recruited 6, with incomplete data on those participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harmony Reynolds, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893579
- Sponsor's protocol ID
- 15-00650
- Status last verified
- Jul 2018
- First submitted
- 30 Aug 2016
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone-delivered Stress Reduction Intervention for Women With Ischemic Heart Disease
- ClinicalTrials.gov ID
- NCT02893579
- Acronym / sponsor ID
- 15-00650
- Conditions
- Ischemic Heart Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: were not able to find enough eligible patients. We recruited 6, with incomplete data on those participants.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 6 Mar 2018 (actual)
- Primary completion
- 6 Jul 2018 (actual)
- Study completion
- 6 Jul 2018 (actual)
- First posted
- 8 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Intervention | Experimental | Behavioral: Early SR interventionStress reduction intervention 1 time a month |
| Delayed Intervention | Experimental | Behavioral: Delayed SR interventionWait list Control |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early SR interventionSelf-directed stress reduction program delivered through a smart-phone application | Behavioural | Early Intervention |
| Delayed SR interventionActivity tracking only for the first month | Behavioural | Delayed Intervention |
Primary outcome
Seattle Angina Questionnaire [SAQ]
Time frame: Change from Baseline to 3 Months
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
Time frame: Change from Baseline to 3 Months
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]
Time frame: Change from Baseline to 3 Months
a 2-item screening tool for depression, which can be assessed further using the Patient Health Questionnaire-9 if positive
2 secondary outcomes
Duke Activity Status Index score
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
Results and safety
The study was stopped early (reason given: were not able to find enough eligible patients. We recruited 6, with incomplete data on those participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harmony Reynolds, MD principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early SR intervention and Delayed SR intervention in people with Ischemic Heart Disease, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: were not able to find enough eligible patients. We recruited 6, with incomplete data on those participants.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seattle Angina Questionnaire [SAQ] (time frame: Change from Baseline to 3 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2018.