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临床试验/NCT06615349
NCT06615349招募中不适用

DigiPall; a Randomized Controlled Trial of Digital Patient Reported Outcome and Biomarker Monitoring in Palliative Care

David Blum2 个研究点 分布在 1 个国家目标入组 382 人开始时间: 2025年6月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
382
试验地点
2
主要终点
rate of unplanned rehospitalisations and emergency visits

研究概览

简要总结

The aim of this study is to test if a system consisting of a wearable device measuring heartbeats and steps, together with daily communication with a chatbot on the smartphone asking the patients about their symptoms and giving tips, can reduce unplanned hospital readmissions and improve well-being in advanced cancer and severely ill patients.

详细描述

The aim of this study is to test the effect of a remote symptom and digital biomarker monitoring system on unplanned hospital readmissions, quality of life and sense of security in advanced cancer patients and patients with severe illnesses in palliative care.

Patients with cancer or other life-threatening illnesses are often burdened with pain and other distressing symptoms. Palliative care is an approach to prevent and relief suffering by means of early identification, assessment and treatment of these symptoms with the overall aim to improve quality of life of patients.

Palliative care wards are established in larger hospitals in Switzerland and provide short-term acute treatment of patients with incurable diseases. More than half of the patients are discharged home. However, unplanned rehospitalisations and emergency visits unfortunately occur frequently. Unplanned rehospitalisations are burdensome for the patient and caregiver and they are associated with higher costs. Up to 50% of unplanned rehospitalisations or hospital readmissions are deemed avoidable.

An unplanned hospital readmission within a specified time frame is an often applied quality benchmark in health care. When patients are discharged from specific palliative care wards, a good interprofessional outpatient or home care service has been most effective. However, close monitoring through home care teams is time consuming, costly, hindered by long distances and home care teams are not available everywhere. Furthermore, in many European countries primary care practices are rarified and reimbursement of home visits are insufficient. Therefore, new and innovative approaches for monitoring of this patient group are needed, especially in view of a growing number of patients and a decreasing number of care givers.

In the digital era self tracking is becoming more fashionable and daily screen-time is increasing. Concerning symptoms and well-being, patients monitoring themselves is the best option, because only they can adequately determine how they feel. Performance status and its deterioration can be remotely assessed by wearables. Mobile health technology is an easy and feasible way to monitor activity and health status.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with established diagnosis of a metastatic cancer/severe illness with limited life expectancy receiving palliative care services
  • Estimated life expectancy <24 months (physician's guess)/ >3 months
  • Karnofsky Index ≥ 50% / ECOG≤ 2
  • Aged >18 years
  • Owns and uses a smartphone
  • Give written informed consent

排除标准

  • Patients under curative treatment
  • Relevant cognitive impairment

结局指标

主要结局

rate of unplanned rehospitalisations and emergency visits

时间窗: 84 days

measure will be derived from hospital reports as well as statements by the patient on a weekly basis

次要结局

  • Quality of Life in palliative cancer care patients (EORTC QLQ-C15-PAL)(91 days)
  • Sense of Security in Care - Patient Edition (SEC-P)(91 days)
  • survival(365 days)

研究者

发起方
David Blum
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

David Blum

Medical Director Palliative Care Center USZ

University of Zurich

研究点 (2)

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