eSDM Tool for Depression in Heart Disease

NM
Overseen ByNathalie Moise, MD, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Columbia University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new online tool designed to help manage depression in people with heart disease. The Electronic Shared Decision Making (eSDM) tool facilitates collaborative treatment decisions between patients and doctors, aiming to reduce depressive symptoms. It is ideal for individuals with coronary heart disease who speak English or Spanish, experience significant depression, and have appointments at certain clinics. Participants will use the tool and undergo assessments at the start and after six months to evaluate changes in their symptoms. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance depression management for heart disease patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this electronic shared decision making tool is safe for depression in heart disease patients?

Research has shown that tools like the electronic shared decision-making (eSDM) tool are generally easy for patients to use. These tools help patients understand their options better, enabling informed choices about their care. In past uses, these tools did not cause any significant problems. They primarily enhance collaboration between patients and doctors. Additionally, these tools have improved patient adherence to treatment plans without causing harm. This suggests that the eSDM tool is safe for patients with heart disease and depression.12345

Why are researchers excited about this trial?

Researchers are excited about the electronic shared decision making (eSDM) tool for depression in heart disease because it offers a personalized approach to treatment. Unlike traditional methods that primarily focus on medication or therapy, the eSDM tool integrates patient preferences and promotes active participation in care decisions. This tool not only screens and activates behavioral changes but also educates both patients and providers, creating a more collaborative healthcare environment. By tailoring interventions to individual patient needs, it has the potential to improve outcomes and patient satisfaction significantly.

What evidence suggests that the eSDM tool is effective for depression in heart disease?

Research has shown that tools like the electronic shared decision-making (eSDM) tool, studied in this trial, can help patients better understand their treatment options. These tools increase patient involvement in their care, potentially improving mental health by reducing symptoms of depression. Early results suggest that patients who actively participate in treatment decisions often feel more satisfied and experience better health outcomes. Although limited data exists specifically on the eSDM tool for heart disease patients with depression, similar tools have shown promise in enhancing patient knowledge and involvement. Active involvement is crucial for effectively managing both heart disease and depression.12467

Who Is on the Research Team?

NM

Nathalie Moise, MD, MS

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You have high levels of depressive symptoms, as indicated by a score of 10 or more on the PHQ9 questionnaire.
I have a history of heart disease.

Exclusion Criteria

I have dementia or severe problems with my memory and thinking.
I do not have severe depression.
I do not speak English or Spanish.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-intervention

Patients receive usual care and are assessed at baseline

Baseline period
1 visit (in-person)

Intervention

Patients complete a web application delivering screening, behavioral activation, and shared decision making (eSDM)

6 months
Ongoing virtual engagement

Follow-up

Participants are monitored for changes in depressive symptoms and quality of life

6 months
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Electronic shared decision making (eSDM) tool
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Electronic shared decision making (eSDM) ToolExperimental Treatment1 Intervention

Electronic shared decision making (eSDM) tool is already approved in United States for the following indications:

🇺🇸
Approved in United States as Electronic Shared Decision Making Tool for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials
1,529
Recruited
2,832,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Published Research Related to This Trial

This randomized controlled trial will assess the effectiveness of a smartphone app designed to enhance patient activation and support shared decision making (SDM) among 260 individuals with schizophrenia-spectrum disorders over a 6-month period.
The study aims to determine if the app can improve self-perceived patient activation and other outcomes related to treatment satisfaction and engagement in mental healthcare, potentially demonstrating the benefits of digital tools in facilitating SDM.
The Momentum trial: the efficacy of using a smartphone application to promote patient activation and support shared decision making in people with a diagnosis of schizophrenia in outpatient treatment settings: a randomized controlled single-blind trial.Vitger, T., Austin, SF., Petersen, L., et al.[2020]
The web-based decision aid significantly improved patients' knowledge about treatment options and reduced decisional conflict among adults with unipolar depression, as shown in a randomized controlled trial with 147 participants.
However, the decision aid did not affect treatment intention or preferences for participation in decision making, indicating that while it enhances understanding, it may not change how patients choose to engage in their treatment decisions.
Effectiveness of a decision aid for patients with depression: A randomized controlled trial.Perestelo-Perez, L., Rivero-Santana, A., Sanchez-Afonso, JA., et al.[2022]
A shared decision-making (SDM) training program for clinicians significantly improved patients' perceived involvement in their treatment decisions for major depressive disorder (MDD), as indicated by higher scores on the Shared Decision Making-Questionnaire-9 (SDM-Q-9) compared to usual care.
Despite the improvement in perceived involvement, the training did not lead to significant changes in decision conflict or secondary outcomes such as patient satisfaction, quality of life, or depressive symptoms, suggesting that while SDM can be implemented, its impact on overall treatment outcomes needs further investigation.
Implementation of a shared decision-making training program for clinicians based on the major depressive disorder guidelines in Japan: A multi-center cluster randomized trial.Takaesu, Y., Aoki, Y., Tomo, Y., et al.[2023]

Citations

eSDM Tool for Depression in Heart DiseaseThis trial tests a digital tool that helps heart disease patients with depression work with their doctors to choose the best treatment.
Shared Decision-Making Tools Implemented in the Electronic ...SDM may involve the use of a decision aid, a type of tool that helps patients consider options for medical decision-making by increasing patient knowledge; ...
Shared Decision-Making Tools Implemented in the ...SDM may involve the use of a decision aid, a type of tool that helps patients consider options for medical decision-making by increasing patient ...
Developing an Individualized Patient Decision Aid for ...Our objective was to develop a patient decision aid (PDA) with patient-specific estimates of outcomes for initial invasive versus conservative management of ...
Human-Centred Design & Development of a Shared ...Human-Centred Design & Development of a Shared Decision Aid for Patients with Chronic Kidney Disease Facing Treatment for Coronary Heart Disease. Author links ...
Increasing Uptake of Depression Screening and Treatment ...To change patient-level behavior, a multimodal shared decision-making (eSDM) tool would provide screening functionality, psychoeducation, ...
Increasing Uptake of Depression Screening and Treatment ...To change patient-level behavior, a multimodal shared decision-making (eSDM) tool would provide screening functionality, psychoeducation, patient activation ( ...
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