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Clinical Trials/NCT06644339
NCT06644339
Not Yet Recruiting
N/A

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

I.M. Sechenov First Moscow State Medical University1 site in 1 country500 target enrollmentOctober 15, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Heart Failure
Sponsor
I.M. Sechenov First Moscow State Medical University
Enrollment
500
Locations
1
Primary Endpoint
complications, decompensations
Status
Not Yet Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 15, 2024
End Date
April 30, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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

Outcomes

Primary Outcomes

complications, decompensations

Time Frame: an average, 1 month after randomization

rate of complications and exacerbations of the main disease

all-cause mortality

Time Frame: an average, 1 months after randomization

mortality rate

cardiovascular mortality

Time Frame: an average, 1 month after randomization

mortality rate

Secondary Outcomes

  • achievement target or maximally tolerated doses(an average, 1 month after randomization)
  • satisfaction(an average, 1 month after randomization)
  • changes in medical adherence(an average, 1 month after randomization)

Study Sites (1)

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