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CompletedNCT04564118INTELLECTUpdated Jan 27, 2021

A Retrospective Analysis of the Adherence to Clinical Practice Guidelines Using the "MedicBK" Digital Platform in Patients With Hypertension and Atrial Fibrillation

An observational study in Atrial Fibrillation and Arterial Hypertension, sponsored by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health. Completed at 1 site in Russian Federation. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2021-01-27.

Sponsored by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health · Observational

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
191
Ages
19 Years and older
Sex
All
01

Study summary

The Clinical Decision Support Systems (CDSS) based on real clinical data and its own algorithms can help to make the right choice. This trial is designed to assess the difference between retrospective electronic medical cards (EMC) therapy prescriptions and MedicBK prescriptions based on key patient characteristics.

Read the detailed description

There is a lot of data from registries about poor adherence to guidelines. It is connected with a problem that patients usually have a lot of comorbidities and physicians need to know сonsequently the huge number of medications and combinations. It is very difficult to decide quickly according to available data from libraries like PubMed. The Clinical Decision Support Systems (CDSS) based on real clinical data and its own Artificial Intelligence algorithms can help to make the right choice. This trial is designed to assess the difference between retrospective electronic medical cards (EMC) therapy prescriptions and MedicBK prescriptions based on key patient characteristics.

Two groups of experts (cardiologists with clinical practice for more than 5 years) will be participating in the trial.

Using main characteristics from EMC the first group of experts will put this data into MedicBK platform and assess retrospective treatment. The next blinded group of experts will perform prescriptions using MedicBK algorithms based on current guidelines and data from available clinical trials. The main hypothesis is the use Clinical Decision Support Systems (CDSS) better than current clinical practice. This option can help to make the right choice of medical combination based on main patient's clinical characteristics

02

Conditions studied

  • Atrial Fibrillation
  • Arterial Hypertension

Keywords

  • atrial fibrillation
  • arterial hypertension
  • digital medicine
  • Clinical Decision Support System
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 191 is close to the median of 210 across 1,359 observational studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health is the lead sponsor of 30 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients diagnosed with nonvalvular atrial fibrillation and essential hypertension having indications for therapy according to European guidelines

Inclusion criteria

  1. Age > 18 years old
  2. Patients diagnosed with nonvalvular atrial fibrillation and essential hypertension having indications for therapy according to European guidelines.

Exclusion criteria

Exclusion Criteria:

  1. Valvular cause of atrial fibrillation
  2. GFR less than 30 ml / min
  3. Active liver disease
  4. Acute coronary syndrome
  5. The presence of thyroid diseases as a cause of atrial fibrillation
  6. Secondary arterial hypertension
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Study design

Observational model
Other
Time perspective
Other
Enrollment
191 participants (actual)
Patient registry
No

Groups and cohorts

  • Group 1

    retrospective data on treatment from EMC

    Drug: Retrospective analysis of assigned treatment

  • Group 2

    Treatment assignment using medicBC CDSS platform in the same cohort of patients

Interventions

  • DrugRetrospective analysis of assigned treatment

    analysis of treatment assigned by physicians within routine clinical practice

06

What researchers measure

Primary outcomes

  1. Assessment of AF/AH treatment guidelines compliance

    Number of electronic medical records not compliant to the AF/AH clinical practice guidelines

    Time frame: 1 MONTH

Secondary outcomes

  1. Assessment of MedicBK programme

    Number of prescriptions from electronic medical records appropriate or inappropriate according to the AF/hypertension clinical practice guidelines in comparison with the treatment's choice of CDSS platform

    Time frame: 1 MONTH

07

Study locations

1 site
  • V.A. Almazov Fnmrc
    Saint-petersburg, 197341, Russian Federation
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04564118
Lead sponsor
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Collaborators
Medicbook LLC
Responsible party
Sponsor
First posted
Sep 25, 2020
Start date
Sep 1, 2020
Primary completion
Nov 1, 2020
Completion
Jan 11, 2021
Last update
Jan 27, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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