Feasibility of a Structured Digital Patient-Reported Assessment Pathway in Older Adults With Acute Leukemia: A Prospective Single-Center Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility of Digital Implementation
研究概览
简要总结
This pilot study will evaluate the feasibility of implementing a structured digital patient-reported assessment pathway in adults aged 65 years or older with acute leukemia. Following activation of the institutional MiAsturSalud/SESPA platform, participants will complete the EORTC QLQ-C30 and FACT-Leu remotely after the baseline visit and will repeat the digital assessment at 3-6 months. The primary outcome will be completion of at least 80% of the baseline digital assessment within 7 days. Secondary outcomes will be caregiver assistance requirement, non-completion of the planned digital follow-up assessment, and elapsed completion time. The study is not designed to establish clinical efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65 years or older.
- •Confirmed diagnosis of acute leukemia of myeloid or lymphoid origin.
- •Active ambulatory follow-up in the Hematology Service at Hospital Universitario Central de Asturias.
- •Ability to understand the questionnaires and provide their own responses, independently or with practical assistance from a caregiver.
- •Access to a compatible internet-enabled digital device, either personally or through a caregiver.
- •Provision of written informed consent.
排除标准
- •Cognitive impairment that, in the treating hematologist's clinical judgment, prevents the participant from understanding the questionnaires or providing their own responses, despite permitted practical assistance from a caregiver.
- •Clinical condition that, in the treating hematologist's judgment, precludes completion of the study procedures.
- •Persistent inability to access or use the MiAsturSalud/SESPA platform despite reasonable technical support.
研究组 & 干预措施
Digital Patient-Reported Assessment Pathway
干预措施: Digital Patient-Reported Assessment Pathway (Other)
结局指标
主要结局
Feasibility of Digital Implementation
时间窗: Within 7 days after baseline.
Proportion of participants completing at least 80% of all required items across the EORTC QLQ-C30 and FACT-Leu baseline digital questionnaire battery.
次要结局
- Time Required for Digital Completion(Within 7 days after baseline.)
- Caregiver Assistance Requirement(Within 7 days after baseline.)
- Non-completion of Planned Digital Follow-up Assessment(From baseline to 3-6 months.)
研究者
Teresa Bernal del Castillo
PhD
Fundación para la Investigación Biosanitaria del Principado de Asturias