跳至主要内容
临床试验/NCT05650814
NCT05650814招募中不适用

Use of a Telematics Device for Daily Monitoring of Vital Signs in Home-care Patients With Advanced Cancer

Fondazione ANT Italia ONLUS2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年5月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
Number of measurements

研究概览

简要总结

The primary goal of this non-profit single-centre randomized pilot interventional study is to evaluate the acceptability of a daily telemonitoring of five vital parameters (heart rate, respiratory rate, blood oxygenation, blood pressure, and body temperature) using a medical device in advanced cancer patients with relevant cardiovascular and respiratory comorbidities assisted at home.

In addition to the standard home care, participants in the intervention group will keep the medical device at home. They will register five vital parameters (heart rate, respiratory rate, blood oxygenation, blood pressure, and body temperature) once a day for eight weeks. Participants belonging to the control group will receive standard home care.

The secondary goals of this study include the following:

  • Analyzing the effect of telemonitoring on patients' quality of life and psychological status.
  • Observing the possible effects of telemonitoring on the caregiver care burden.
  • Assessing the possible effects of telemonitoring on the caregiver perceived satisfaction with the home care received.
  • Comparing the number of physician and nurse home visits and phone calls between the patients using the device and patients in standard home care.
  • Comparing the number of emergency room visits, admissions, and hospitalization days between the patients using the device and patients in standard home care.

详细描述

BACKGROUND

The overloading of healthcare facilities and the need to prevent the risk of infection during Covid-19 emergency have highlighted the need to implement significant changes in the organization and delivery of healthcare services, mainly when these are aimed at the most fragile segments of the population, as in the case of palliative care. In order to assist with an efficient program of home palliative care for an increasing number of patients, scientific evidence is progressively underlining the need to integrate telemedicine intervention into home care protocols. The introduction of telemonitoring systems in home palliative care aims to facilitate more effective patient care, reducing both emergency room and hospital admissions and improving symptoms of distress, anxiety, and depression in patients and caregivers. Self-monitoring also increases patients' awareness by making them feel part of their care pathway and active contributors to their well-being.

Telemonitoring mainly uses medical devices to record parameters relating to the patient's state of health or treatment progress. Once registered, the data are shared on a cloud platform and then viewed by the physician, who can intervene in real-time in the event of clinically significant anomalies reported by the system.

In the panorama of medical devices used for this purpose in Italy, there is ButterfLife® (VST Srl, Modena Italy), a medical device similar to a joypad, designed by the Unimore spinoff VST (Vital Signal in a Touch), which, thanks to special sensors, allows to measure simultaneously the five primary vital parameters defined by the WHO in 90 seconds (heart rate, respiratory rate, blood oxygenation, blood pressure and body temperature). To record these parameters, the patient has to place both hands on the device, and the data collected are immediately transmitted to a portal whose software (VST-FIVE) calculates the vital signs and allows visualization the sharing with the doctor via a Wi-Fi network. In this way, it is possible to ensure early detection of worsening and failure of the health state enabling a timely activation of appropriate intervention in the home setting. The recorded data remains available for subsequent evaluation, long-term monitoring, and offline analysis.

In the present study, the ANT Foundation proposes to evaluate the feasibility and outcomes of a daily monitoring model of five vital signs (heart rate, respiratory rate, blood oxygenation, blood pressure and body temperature) conducted through the ButterfLife medical device in cancer patients assisted at home with cardiovascular and respiratory comorbidities.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Investigator, 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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Number of measurements

时间窗: 8 weeks

Number of measurements/week per patient.

Acceptability

时间窗: 8 weeks

Percentage of eligible patients proposed for the study who agree to participate.

次要结局

  • Psychological status(Day 1, day 28 and day 56)
  • Perceived health status(Day 1, day 28 and day 56)
  • Quality of life(Day 1, day 28 and day 56)
  • Caregiver burden(Day 1, day 28 and day 56)
  • Satisfaction with care(Day 56)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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