Clinical trial NCT06644339: Remote Multichannel Monitoring of Patients With Chronic DIseAses Using Speech technoLogies Based On Artificial intelliGence
Official title: Remote Multichannel Monitoring of Patients With Chronic DIseAses Using Speech technoLogies Based On Artificial intelliGence
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
voice assistant
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
Collaborators: name: PJSC VimpelCom
First posted: 2024-10-16
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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\&#39;s characteristics meet the inclusion and exclusion criteria and confirming the patient\&#39;s ability to use the \&#34;voice assistant\&#34;, 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 \&#34;voice assistant\&#34; 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.

Eligibility criteria: 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

Primary outcomes:
measure: cardiovascular mortality
timeFrame: an average, 1 month after randomization
measure: all-cause mortality
timeFrame: an average, 1 months after randomization
measure: complications, decompensations
timeFrame: an average, 1 month after randomization
Secondary outcomes:
measure: achievement target or maximally tolerated doses
timeFrame: an average, 1 month after randomization
measure: satisfaction
timeFrame: an average, 1 month after randomization
measure: changes in medical adherence
timeFrame: an average, 1 month after randomization
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: 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
Study officials:
affiliation: The Sechenov First Moscow State Medical University
name: Maria Kozhevnikova, Professor
role: PRINCIPAL_INVESTIGATOR
References: