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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Voice assistant
  Robotic remote monitoring of patients using unique algorithms developed for virtual operator speech technology and a BI system by voice commands on the "question-answer" principle. It allows us to automate data collection and obtain information about the patient's well-being and his vital signs (blood pressure, heart rate, weight) depending on disease. Follow-up and management of disease provided by specialists at participating institutions.

Первичные конечные точки

• cardiovascular mortality [Срок оценки: an average, 1 month after randomization]
• all-cause mortality [Срок оценки: an average, 1 months after randomization]
• complications, decompensations [Срок оценки: an average, 1 month after randomization]

Вторичные конечные точки (3)

• achievement target or maximally tolerated doses [Срок оценки: an average, 1 month after randomization]
• satisfaction [Срок оценки: an average, 1 month after randomization]
• changes in medical adherence [Срок оценки: an average, 1 month after randomization]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Россия · 1 центр

• Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First M — Moscow

Идентификаторы

NCT: NCT06644339 · DIALOG2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗