NCT04564118

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
191

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2021

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

September 21, 2020

Last Update Submit

January 26, 2021

Conditions

Atrial FibrillationArterial Hypertension

Keywords

atrial fibrillationarterial hypertensiondigital medicineClinical Decision Support System

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Assessment of MedicBK programme

    1 MONTH

Study Arms (2)

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

Retrospective analysis of assigned treatmentDRUG

analysis of treatment assigned by physicians within routine clinical practice

Group 1

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

V.A. Almazov Fnmrc

Saint Petersburg, 197341, Russia

Location

MeSH Terms

Conditions

Atrial FibrillationHypertension

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2020

First Posted

September 25, 2020

Study Start

September 1, 2020

Primary Completion

November 1, 2020

Study Completion

January 11, 2021

Last Updated

January 27, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)