Telemonitoring Enhanced Support for Depression Self Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 243
- 试验地点
- 14
- 主要终点
- Depressive symptom severity
研究概览
简要总结
The objective of this research is to test the efficacy of "CarePartners for Depression" (CP-D) intervention, which was designed to increase between visit monitoring of depression status and enhance self-management.
**In order to participate, subjects must be patients at participating clinics: Alcona Health Center, Cherry Street Health Services, Dua Family Practice, Morang Chester.
详细描述
This project will test a practical intervention that uses low cost technologies to activate depressed patients' existing social networks for self-management support. The intervention links patients with a "CarePartner" (CP), i.e., a non-household family member or close friend who is willing to support the patient in coordination with the clinician and any existing in-home caregiver (ICG). Through weekly automated telemonitoring, patients report their mood and self-management status, and receive tailored guidance on self-management. The CP receives a corresponding update along with guidance on how to best support the patient's self-management efforts, and the primary care team is notified about clinically urgent situations. The intervention will be tested among depressed primary care patients from clinics serving low-income and underinsured patients, whom the intervention was especially designed to benefit. Specific Aim 1 is to conduct a randomized controlled trial to compare the effectiveness of one year of telemonitoring-supported CP for depression versus usual care (control) on depression severity. Specific Aim 2 is to examine key secondary outcomes (response and remission, impairment, well-being, caregiving burden, healthcare costs) and potential moderators. Specific Aim 3 is to use a mixed-methods approach to enrich our interpretation of the statistical associations, and to discover strategies to enhance the intervention's acceptability, effectiveness, and sustainability. If the intervention proves effective without increasing clinician burden or marginal costs, then its subsequent implementation could yield major public health benefits, especially in medically underserved populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •at least 2 outpatient primary care visits in the past 2 years, 1 within the past 13 months
- •depression diagnosis in medical chart problem list or billing record (ICD9 codes: 296.20-.26, .30-.36, 296.4-.9, 298.0, 300.4, 309.0-.1, 309.28, 311.00) during the past 2 years
- •current PHQ >10 (non-mild depressive symptoms)
- •at least 21 years old
- •comfortable speaking English
- •can use a touch-tone phone
- •can identify at least 1 eligible CarePartner
- •not in palliative care, on transplant waitlist, or <1 year life expectancy
- •free of major cognitive impairment or psychiatrically unstable
- •not experiencing domestic abuse or stalking
排除标准
- •Limited life expectancy (e.g., advanced stage cancer/heart failure/on oxygen/end stage renal disease), receiving palliative care
- •At risk for domestic abuse, PHQ<10, end stage renal disease, lung cancer, dementia, bipolar disease, schizophrenia, limited life expectancy (advanced stage cancer/heart failure/on oxygen), alcohol problems, receiving palliative care
- •Unable to speak English
- •Not planning to get all or most of care at study site
- •Primary care physician not affiliated with study site
- •Unable to use telephone to respond to weekly automated self-management support calls
- •Unable to nominate an eligible CP
研究组 & 干预措施
CarePartners for depression
For one year, patients receive weekly automated telemonitoring of mood and self-management, while their CarePartners receive weekly reports of the patient's assessment results with tailored instructions on supporting the patient's depression self-management.
干预措施: CarePartners for depression (Behavioral)
Usual care
Usual medical care.
结局指标
主要结局
Depressive symptom severity
时间窗: 12 months after randomization
Patient Health Questionnaire 9 (PHQ-9).
次要结局
- Positive well-being(12 months after randomization)
- Health care costs(12 months after randomization)
- Depression remission rate(12 months after randomization)
- Depression-related functional impairment(12 months after randomization)
研究者
James Aikens, PhD
Associate Professor of Family Medicine
University of Michigan
