"Evaluating the Effectiveness of an AI-Based Software in Personalizing High-Quality End-of-Life Care for the Elderly: A Randomized Controlled Clinical Trial"
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 主要终点
- Change in Quality of Life Score
研究概览
简要总结
This study aims to evaluate the effectiveness of an artificial intelligence (AI)-based software in personalizing high-quality end-of-life care for elderly patients. As the elderly population grows, providing tailored and quality care during the final stages of life becomes increasingly important. This AI software continuously monitors vital signs and behaviors through wearable sensors, offers smart medication reminders, alerts the care team to potential risks, and provides personalized care plans along with psychological and social support.
The study is designed as a randomized controlled trial comparing two groups: one receiving standard end-of-life care and the other using the AI software. Key outcomes include improving quality of life, reducing adverse events like falls and emergency hospitalizations, increasing patient and family satisfaction, improving medication management, and reducing caregiver burden. Data will be collected over six months to assess these effects. The results will help determine whether AI technology can enhance end-of-life care for seniors and support families and healthcare providers.
详细描述
This section provides a comprehensive overview of the study design, objectives, population, interventions, and methods without repeating information already included in other sections of the record. It elaborates on the rationale for using AI-based software to personalize end-of-life care for elderly patients, details the randomized controlled trial setup, explains inclusion and exclusion criteria, intervention specifics, outcome measures, data collection methods, and planned statistical analyses. This description ensures a clear understanding of the study's scope and methodology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60 years
- •Clinical diagnosis of being in the end-of-life stage, based on criteria such as the Karnofsky Performance Scale or Palliative Performance Scale
- •Informed consent obtained from the participant or legal representative
- •Ability to use technology independently or with support provided by the research team
- •Access to necessary equipment for the intervention (e.g., wearable sensors, smartphone/tablet)
排除标准
- •Presence of severe cognitive impairment preventing software use
- •Voluntary withdrawal from the study at any stage
- •Critical medical deterioration or death during the study
- •Poor adherence or insufficient engagement with the intervention software in the intervention group
结局指标
主要结局
Change in Quality of Life Score
时间窗: Up to 3 months after intervention start
Assessed using a validated instrument such as the Quality of Life at the End of Life (QUAL-E) scale to measure overall well-being, comfort, and satisfaction with care during end-of-life.
次要结局
未报告次要终点
研究者
Amir Vahedian-Azimi
Professor
Baqiyatallah Medical Sciences University