A Retrospective Analysis of the Adherence to Clinical Pra... | NCT04564118

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

NCT04564118

Sponsor

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

Status

Completed

Last Update Posted

Jan 27, 2021Actual

Enrollment

191Actual

Phase

Not provided

Conditions

Atrial Fibrillation
Arterial Hypertension

Interventions

Retrospective analysis of assigned treatment

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2020Actual

Primary Completion Date

Nov 1, 2020Actual

Completion Date

Jan 11, 2021Actual

First Submitted Date

Sep 21, 2020

First Submission Date that Met QC Criteria

Sep 21, 2020

First Posted Date

Sep 25, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2021

Last Update Posted Date

Jan 27, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of HealthOTHER

Collaborators

Name	Class
Medicbook LLC	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

191Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Retrospective analysis of assigned treatment	Drug	analysis of treatment assigned by physicians within routine clinical practice	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of AF/AH treatment guidelines compliance	Number of electronic medical records not compliant to the AF/AH clinical practice guidelines	1 MONTH

Secondary Outcomes

Measure	Description	Time Frame
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	1 MONTH

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Valvular cause of atrial fibrillation
GFR less than 30 ml / min
Active liver disease
Acute coronary syndrome
The presence of thyroid diseases as a cause of atrial fibrillation
Secondary arterial hypertension

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
V.A. Almazov Fnmrc		Saint Petersburg		197341	Russia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D014652	Vascular Diseases

ID	Term
D001281	Atrial Fibrillation
D006973	Hypertension