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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure; Diabetes Mellitus; Arterial Hypertension; Total Knee Replacement; Lymphoproliferative Disease
• Intervention / Treatment: Device: Voice assistant

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Kozhevnikova, Professor; Phone Number: +79265605019; Email: kozhevnikova_m_v@staff.sechenov.ru
• Study Contact Backup: Name: Aleksei Emelianov, Assistant; Phone Number: +79998305785; Email: emelyanov_a_v@staff.sechenov.ru

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 119048
    • Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University), University Clinical Hospital No.1
    • Contact: Maria Kozhevnikova; Phone Number: +79265605019; Email: kozhevnikova_m_v@staff.sechenov.ru
    • Contact: Elena Zheleznykh; Phone Number: +79104539039; Email: elenavlvp@gmail.com
    • Principal Investigator: Maria Kozhevnikova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Heart Failure; Patients with chronic heart failure who was hospitalized due to decompensation of their condition. Their condition should be stabilized before discharge. Robotic remote monitoring of patients using unique algorithms developed for virtual operator speech technology and a BI system by voice commands to automate data collection and obtain information about the patient's well-being and his vital signs (blood pressure, heart rate, weight) related to heart failure.	Device: 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.
Experimental: Diabetes mellitus; Patients with diabetes mellitus who was hospitalized with unstable glucose level. Their condition should be stabilized before discharge. Robotic remote monitoring of patients using unique algorithms developed for virtual operator speech technology and a BI system by voice commands to automate data collection and obtain information about the patient's well-being and his vital signs (blood pressure, heart rate, weight, glucose) related to diabetes mellitus.	Device: 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.
Experimental: Arterial hypertension; Patients with arterial hypertension who was hospitalized with unstable arterial pressure. Their condition should be stabilized before discharge. Robotic remote monitoring of patients using unique algorithms developed for virtual operator speech technology and a BI system by voice commands to automate data collection and obtain information about the patient's well-being and his vital signs (blood pressure, heart rate, hypotension sings, signs of damage to target organs).	Device: 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.
Experimental: Lymphoproliferative diseases; Patients with any lymphoproliferative disease who is undergoing chemotherapy. Their condition should be stabilized before discharge. Robotic remote monitoring of patients using unique algorithms developed for virtual operator speech technology and a BI system by voice commands to automate data collection and obtain information about the patient's well-being and his vital signs (blood pressure, heart rate) related to chemotherapy complications.	Device: 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.
Experimental: Total knee replacement; Patients who underwent total knee replacement. Their condition should be stabilized before discharge. Robotic remote monitoring of patients using unique algorithms developed for virtual operator speech technology and a BI system by voice commands to automate data collection and obtain information about the patient's well-being and his vital signs (pain, fever) related to replacement complications.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiovascular mortality	mortality rate	an average, 1 month after randomization
all-cause mortality	mortality rate	an average, 1 months after randomization
complications, decompensations	rate of complications and exacerbations of the main disease	an average, 1 month after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
achievement target or maximally tolerated doses	achievement target or maximally tolerated doses for CHF, DM and AH	an average, 1 month after randomization
satisfaction	satisfaction of patients and doctors with the robotic speech questionnaire	an average, 1 month after randomization
changes in medical adherence	change in amount of taking drugs and doses	an average, 1 month after randomization

Collaborators and Investigators

• Sponsor: I.M. Sechenov First Moscow State Medical University
• Collaborators: PJSC VimpelCom
• Investigators: Principal Investigator: Maria Kozhevnikova, Professor, The Sechenov First Moscow State Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): October 15, 2024
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: October 3, 2024
• First Submitted That Met QC Criteria: October 15, 2024
• First Posted (Actual): October 16, 2024

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 15, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: telemedicine; heart failure; mHealth; knee replacement; arterial hypertension; diabetes mellitus; remote monitoring; lymphoproliferative diseases; voice assistant
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Lymphatic Diseases; Immunoproliferative Disorders; Endocrine System Diseases; Disease Attributes; Heart Failure; Hypertension; Diabetes Mellitus; Chronic Disease; Lymphoproliferative Disorders
• Other Study ID Numbers: DIALOG2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: According to the Local Ethics Committee's rules, we are not allowed to provide this data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No