跳至主要内容
临床试验/NCT06644339
NCT06644339尚未招募不适用

Remote Multichannel Monitoring of Patients With Chronic DIseAses Using Speech technoLogies Based On Artificial intelliGence

I.M. Sechenov First Moscow State Medical University2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2024年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
500
试验地点
2
主要终点
complications, decompensations

研究概览

简要总结

DIALOG is a study to assess the efficacy and safety of remote patient monitoring using virtual operator voice technologies and a business intelligence (BI) system for timely detection, prevention of early complications, worsening of the condition, and other adverse events in patients who have been discharged from the hospital.

详细描述

After ensuring that the patient's characteristics meet the inclusion and exclusion criteria and confirming the patient's ability to use the "voice assistant", as provided in the research protocol, patients who have completed the briefing will be able to use the voice assistant at home. During the month, robotic remote monitoring of patients using unique algorithms developed for virtual operator speech technology and a BI system will be conducted for five groups of patients (CHF, DM, AH, LPD, and patients who underwent total knee replacement) who have been discharged from the hospital. The system developed allows for quick surveys, collection of data on patient conditions, and convenient transfer of this data to the physician. The physician will receive information on patient status in a graphical form using a traffic light system. In the event of any red flags, the physician will contact the patient for further discussion on treatment strategies. The study will evaluate the efficacy and safety of utilizing the "voice assistant" by assessing the achievement of target values for controlled parameters, evaluating patient satisfaction and adherence to treatment, reducing the number of repeat hospitalization, and reducing overall mortality and cardiovascular-related mortality.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

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

  • Disease diagnosed according to the latest Clinical practice guidelines
  • Stable condition at the time of discharge from the hospital
  • Written informed consent to participate in the study
  • Non-inclusion criteria:
  • Diagnosed dementia or severe cognitive impairment
  • The inability to use automatic devices to register blood pressure at home, a blood glucose meter
  • Alcohol or drug abuse
  • Inability to contact a voice assistant and other study requirements, due to major co-morbidities, social or financial issues, or a history of noncompliance with medical regimens, that might compromise the patient's ability to understand and/or comply with the protocol instructions or follow-up procedures

排除标准

  • Unwillingness of the patient to continue participating in the study
  • The development of conditions related to the criteria of non-inclusion

结局指标

主要结局

complications, decompensations

时间窗: an average, 1 month after randomization

rate of complications and exacerbations of the main disease

all-cause mortality

时间窗: an average, 1 months after randomization

mortality rate

cardiovascular mortality

时间窗: an average, 1 month after randomization

mortality rate

次要结局

  • achievement target or maximally tolerated doses(an average, 1 month after randomization)
  • satisfaction(an average, 1 month after randomization)
  • changes in medical adherence(an average, 1 month after randomization)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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