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

Not Applicable

Not yet recruiting

• Conditions: Heart Failure; Diabetes Mellitus; Arterial Hypertension; Lymphoproliferative Disease; Total Knee Replacement

• Registration Number: NCT06644339
• Lead Sponsor: I.M. Sechenov First Moscow State Medical University

Brief Summary

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.

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 Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-03
• Study Start: 2024-10-15
• Study First Submitted QC: 2024-10-15
• Last Update Submitted: 2024-10-15
• Study First Posted: 2024-10-16
• Last Update Posted: 2024-10-16
• Primary Completion: 2025-02-28
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
all-cause mortality	an average, 1 months after randomization	mortality rate
complications, decompensations	an average, 1 month after randomization	rate of complications and exacerbations of the main disease
cardiovascular mortality	an average, 1 month after randomization	mortality rate

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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; 🇷🇺 Moscow, Russian Federation