An Information tecHnology Approach to implEmenting Depression treAtment in caRdiac patienTs: [iHeartDepCare Trial]
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 361
- 试验地点
- 2
- 主要终点
- Beck Depression Index (BDI-II)
研究概览
简要总结
The purpose of this study is to examine the effect of a brief electronic shared decision making (eSDM) intervention on depressive symptoms in coronary heart disease patients with elevated depressive symptoms.
详细描述
Depression is common in patients with coronary heart disease and associated with increased cardiac morbidity and mortality. Treating depressive symptoms appears to improve depressive symptoms and quality of life. Despite expert recommendations to screen and treat depressive symptoms fewer coronary heart disease patients engage in depression treatment than the general population, perhaps due to 1) sub-optimal provider awareness and referral rates and 2) low self-efficacy, stigma and misattribution of depressive symptoms among coronary heart disease patients. In addition, few real world theory-informed implementation trials exist for improving screening and treatment in outpatient settings.
The specific aim is to determine whether an electronic shared decision making (eSDM) and behavioral activation tool improves depressive symptoms and treatment initiation in coronary heart disease patients with elevated depressive symptoms. To accomplish these aims, a hybrid effectiveness-implementation trial will be conducted using a pre-post design across socioeconomically diverse cardiology and primary care clinics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of coronary heart disease
- •English or Spanish Speaking
- •Elevated Depressive symptoms (PHQ9 ≥10)
排除标准
- •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
结局指标
主要结局
Beck Depression Index (BDI-II)
时间窗: Baseline, Follow-up visit (approximately 6 months)
Change in total BDI (21-item measure of depressive symptoms \[0-63\]; higher score constitutes worse burden of symptoms) from baseline to follow visit during the pre-intervention period compared to post-intervention period
次要结局
- Proportion of patients who initiate treatment(Baseline, Follow-up visit (approximately 6 months))
- Mean Patient Activation(Baseline)
- Mean Decisional Conflict Scale(Baseline)
- Mean change in quality of life (QoL)(Baseline, Follow-up visit (approximately 6 months))
研究者
Nathalie Moise
Assistant Professor of Medicine, Dept of Medicine
Columbia University