Heart FailureDIALOGNCT06644339
Remote Multichannel Monitoring of Patients With Chronic DIseAses Using Speech technoLogies Based On Artificial intelliGence
A study testing Voice assistant in people with Heart Failure and Diabetes Mellitus, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Diabetes Mellitus, Arterial Hypertension
- What is being tested?
- Voice assistant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteRussia
- Study dates
- 15 Oct 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unwillingness of the patient to continue participating in the study
- The development of conditions related to the criteria of non-inclusion
Trial locations and contacts
1 site in 1 country.
Russia1 site
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
Maria Kozhevnikova, +79265605019, kozhevnikova_m_v@staff.sechenov.ru
Elena Zheleznykh, +79104539039, elenavlvp@gmail.com
About this study
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.
Read the 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.
- Conditions
- Heart Failure, Diabetes Mellitus, Arterial Hypertension, Lymphoproliferative Disease, Total Knee Replacement
- Being tested
- Voice assistant
- Keywords
- heart failure, diabetes mellitus, arterial hypertension, lymphoproliferative diseases, knee replacement, remote monitoring, mHealth, telemedicine, voice assistant
- Medical subject headings
- Heart Failure, Diabetes Mellitus, Hypertension, Lymphoproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voice assistantDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Heart Failure | Experimental | 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. Receives: Device: Voice assistant |
| Diabetes mellitus | Experimental | 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. Receives: Device: Voice assistant |
| Arterial hypertension | Experimental | 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). Receives: Device: Voice assistant |
| Lymphoproliferative diseases | Experimental | 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. Receives: Device: Voice assistant |
| Total knee replacement | Experimental | 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. Receives: Device: Voice assistant |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiovascular mortality
mortality rate
Measured: an average, 1 month after randomization
all-cause mortality
mortality rate
Measured: an average, 1 months after randomization
complications, decompensations
rate of complications and exacerbations of the main disease
Measured: an average, 1 month after randomization
Secondary outcomes (3)
achievement target or maximally tolerated doses
achievement target or maximally tolerated doses for CHF, DM and AH
Measured: an average, 1 month after randomization
satisfaction
satisfaction of patients and doctors with the robotic speech questionnaire
Measured: an average, 1 month after randomization
changes in medical adherence
change in amount of taking drugs and doses
Measured: an average, 1 month after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start15 Oct 2024 (estimated)
- Primary completion28 Feb 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- PJSC VimpelCom
- Responsible party
- Sponsor
- Investigators
- Maria Kozhevnikova, Professor, Principal investigator, The Sechenov First Moscow State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06644339
- Sponsor's protocol ID
- DIALOG2024
- Acronym
- DIALOG
- Status last verified
- Oct 2024
- First submitted
- 3 Oct 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: According to the Local Ethics Committee\'s rules, we are not allowed to provide this data.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Multichannel Monitoring of Patients With Chronic DIseAses Using Speech technoLogies Based On Artificial intelliGence
- ClinicalTrials.gov ID
- NCT06644339
- Acronym / sponsor ID
- DIALOG / DIALOG2024
- Conditions
- Heart Failure, Diabetes Mellitus, Arterial Hypertension, Lymphoproliferative Disease, Total Knee Replacement
- Keywords
- heart failure, diabetes mellitus, arterial hypertension, lymphoproliferative diseases, knee replacement, remote monitoring, mHealth, telemedicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Collaborators
- PJSC VimpelCom
- Study start
- 15 Oct 2024 (estimated)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Heart Failure | Experimental | Device: Voice assistantPatients 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. |
| Diabetes mellitus | Experimental | Device: Voice assistantPatients 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. |
| Arterial hypertension | Experimental | Device: Voice assistantPatients 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). |
| Lymphoproliferative diseases | Experimental | Device: Voice assistantPatients 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. |
| Total knee replacement | Experimental | Device: Voice assistantPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- Diagnosed dementia or severe cognitive impairment
- The inability to use automatic devices to register blood pressure at home, a blood glucose meter
Key exclusion criteria (2 listed)
- Unwillingness of the patient to continue participating in the study
- The development of conditions related to the criteria of non-inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voice assistantRobotic 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. | Device | Arterial hypertension, Diabetes mellitus, Heart Failure, Lymphoproliferative diseases, Total knee replacement |
Primary outcome
cardiovascular mortality
Time frame: an average, 1 month after randomization
mortality rate
all-cause mortality
Time frame: an average, 1 months after randomization
mortality rate
complications, decompensations
Time frame: an average, 1 month after randomization
rate of complications and exacerbations of the main disease
3 secondary outcomes
achievement target or maximally tolerated doses
Time frame: an average, 1 month after randomization
satisfaction
Time frame: an average, 1 month after randomization
changes in medical adherence
Time frame: an average, 1 month after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Individual participant dataSharing planned: No. According to the Local Ethics Committee\'s rules, we are not allowed to provide this data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Kozhevnikova, Professor principal investigator
The Sechenov First Moscow State Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Voice assistant in people with Heart Failure and Diabetes Mellitus, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Kozhevnikova, Professor (+79265605019, kozhevnikova_m_v@staff.sechenov.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiovascular mortality (time frame: an average, 1 month after randomization). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.