Improving depression treatment in heart disease patients using an electronic tool
An Information TecHnology Approach to ImplEmenting Depression TreAtment in CaRdiac PatienTs: [iHeartDepCare Trial]
NA · Columbia University · NCT03882411
This study is testing a new electronic tool to help heart disease patients with depression start treatment and feel better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Columbia University (other) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT03882411 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of an electronic shared decision making (eSDM) intervention designed to address depressive symptoms in patients with coronary heart disease. It focuses on enhancing treatment initiation and reducing depressive symptoms through a hybrid effectiveness-implementation approach in diverse outpatient settings. The study will involve a pre-post design across various cardiology and primary care clinics, targeting patients who exhibit elevated depressive symptoms. By addressing barriers to treatment, the study seeks to improve both mental health and quality of life for these patients.
Who should consider this trial
Good fit: Ideal candidates include patients with a history of coronary heart disease who are English or Spanish speaking and exhibit elevated depressive symptoms.
Not a fit: Patients with a history of psychosis, schizophrenia, bipolar disorder, or severe cognitive impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the mental health and quality of life for patients with coronary heart disease experiencing depression.
How similar studies have performed: Other studies have shown promise in using technology-based interventions for improving mental health outcomes, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * History of coronary heart disease * English or Spanish Speaking * Elevated Depressive symptoms (PHQ9 ≥10) * Appointment at participating cardiology or primary care clinics Exclusion Criteria: * Under the care of a psychiatrist \[\*\*On 6/22/2022, this exclusion criteria was removed for those clusters of clinics not already in the post-implementation period\*\*\] * Diagnosis/history of psychosis or schizophrenia * Diagnosis/history of bipolar disorder * Attempted suicide * Non-English or Spanish speaking * Dementia or severe cognitive impairment * Non-elevated depressive symptoms * Alcohol or substance abuse * Pregnancy
Where this trial is running
New York, New York
- Columbia University Irving Medical Center/New York Presbyterian Hospital — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Nathalie Moise, MD, MS — Columbia University
- Study coordinator: Nathalie Moise, MD, MS
- Email: nm2562@cumc.columbia.edu
- Phone: 2123422889
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Depressive Symptoms, Coronary Heart Disease, Implementation science