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NCT Number: NCT06644339

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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, 119048, Russia

Location contact

Elena Zheleznykh

CONTACT

[email protected]

+79104539039

Maria Kozhevnikova

CONTACT

[email protected]

+79265605019

Maria Kozhevnikova

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Voice assistant

Device

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.

Primary outcomes

  1. cardiovascular mortality

    Time frame: an average, 1 month after randomization

    mortality rate

  2. all-cause mortality

    Time frame: an average, 1 months after randomization

    mortality rate

  3. complications, decompensations

    Time frame: an average, 1 month after randomization

    rate of complications and exacerbations of the main disease

Secondary outcomes

  1. achievement target or maximally tolerated doses

    Time frame: an average, 1 month after randomization

    achievement target or maximally tolerated doses for CHF, DM and AH

  2. satisfaction

    Time frame: an average, 1 month after randomization

    satisfaction of patients and doctors with the robotic speech questionnaire

  3. changes in medical adherence

    Time frame: an average, 1 month after randomization

    change in amount of taking drugs and doses

Study contacts

Contact information is provided by the study sponsor or research team.

Aleksei Emelianov, Assistant

CONTACT

[email protected]

+79998305785

Maria Kozhevnikova, Professor

CONTACT

[email protected]

+79265605019

Sponsors and collaborators

Lead sponsor

I.M. Sechenov First Moscow State Medical University

Other

Collaborators

  • PJSC VimpelCom

Registry information

Acronym: DIALOG

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 16, 2024
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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