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Behavioral Intervention

eSDM Tool for Depression in Heart Disease

N/A
Recruiting
Led By Nathalie Moise, MD, MS
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
History of coronary heart disease
Be older than 18 years old
Must not have
Dementia or severe cognitive impairment
Non-English or Spanish speaking
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, follow-up visit (approximately 6 months)
Awards & highlights

Summary

This trial will test whether a brief electronic intervention can help reduce depressive symptoms in coronary heart disease patients.

Who is the study for?
This trial is for heart disease patients who also have significant depression symptoms (PHQ9 score ≥10) and speak English or Spanish. It's not for those with psychosis, schizophrenia, bipolar disorder, recent suicide attempts, severe cognitive issues, non-elevated depression symptoms, current pregnancy, or substance abuse problems.
What is being tested?
The study is testing an electronic shared decision making tool (eSDM) designed to help coronary heart disease patients manage elevated depressive symptoms more effectively through technology-assisted care.
What are the potential side effects?
Since this intervention involves a decision-making support tool rather than medication or invasive therapy, traditional physical side effects are not expected. However, emotional distress due to discussing sensitive health information may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a history of heart disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have dementia or severe problems with my memory and thinking.
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I do not speak English or Spanish.
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I have been diagnosed with or have a history of psychosis or schizophrenia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, follow-up visit (approximately 6 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, follow-up visit (approximately 6 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Beck Depression Index (BDI-II)
Secondary study objectives
Mean Decisional Conflict Scale
Mean Patient Activation
Mean change in quality of life years (QALYs)
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Electronic shared decision making (eSDM) ToolExperimental Treatment1 Intervention
In the pre-intervention period, patients in clinic clusters will receive usual care. When a clinic cluster's randomly allotted intervention period arrives, coronary heart disease patients in that given clinic cluster will complete a web application, which delivers screening, behavioral activation and shared decision making (eSDM), and providers will receive education and a patient preference report generated from the application. During both the pre and post intervention periods, patients will be assessed at baseline and 6 month follow up.

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,889 Previous Clinical Trials
47,833,839 Total Patients Enrolled
Columbia UniversityLead Sponsor
1,471 Previous Clinical Trials
2,535,982 Total Patients Enrolled
Nathalie Moise, MD, MSPrincipal Investigator - Columbia University
New York Presbyterian Hospital-Columbia Presbyterian Center, Trustees of Columbia University in the City of New York
1 Previous Clinical Trials
266 Total Patients Enrolled

Media Library

Electronic shared decision making (eSDM) tool (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03882411 — N/A
Coronary Heart Disease Research Study Groups: Electronic shared decision making (eSDM) Tool
Coronary Heart Disease Clinical Trial 2023: Electronic shared decision making (eSDM) tool Highlights & Side Effects. Trial Name: NCT03882411 — N/A
Electronic shared decision making (eSDM) tool (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03882411 — N/A
~26 spots leftby Mar 2025
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