LiveSMART: A Sequential, Multiple Assignment Randomized Trial to Prevent Falls in Patients With Cirrhosis - Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 52
- 试验地点
- 3
- 主要终点
- Comprehensive Score for Financial Toxicity - Functional Assessment of Chronic Illness Therapy v2 (COST-FACIT)
研究概览
简要总结
The LIVE-SMART supplementary study will assess social determinants of health (income, education, neighborhood deprivation), financial burden (out-of-pocket costs, productivity loss), financial distress (patient and caregiver-reported outcomes), and financial toxicity (healthcare utilization) among LIVE-SMART participants and their caregivers.
Participants for this supplementary study are participants in the primary study (NCT05794555) and their caregivers.
详细描述
The supplementary study will augment the primary study the following ways: 1) adding longitudinal questionnaires about financial burden, distress, and toxicity among patients and their caregivers, 2) assessing detailed data and healthcare utilization and associated costs, 3) extending study follow-up by 48 weeks from 24 to 72 weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult 18 years of age or older
- •Informal caregiver of a participant enrolled in LIVE-SMART
- •English speaking
排除标准
- •Non-English speaking
研究组 & 干预措施
Caregivers
Caregivers are a relative, spouse, partner, friend or neighbor who has a significant personal relationship with and provides a broad range of assistance for a patient, including consistent involvement in their medical care.
结局指标
主要结局
Comprehensive Score for Financial Toxicity - Functional Assessment of Chronic Illness Therapy v2 (COST-FACIT)
时间窗: Up to 72 weeks
Financial toxicity will be measured using the COST-FACIT v2 tool, a 12-item, validated self-reported scale validated reflecting experiences of the prior 7-days scored 0-44 (with higher scores indicating more toxicity).
次要结局
- Out-of-pocket Healthcare Cost Questionnaire (OOP)(Up to 72 weeks)
- Medications(Up to 72 weeks)
- Work Productivity and Activity Impairment Questionnaire v2 (WPAI)(Up to 72 weeks)
研究者
Elliot B. Tapper
Associate Professor of Internal Medicine
University of Michigan