NCT04791046

Brief Summary

A retrospective analysis

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 8, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
Last Updated

March 11, 2021

Status Verified

March 1, 2021

Enrollment Period

2 months

First QC Date

March 8, 2021

Last Update Submit

March 9, 2021

Conditions

Adherence to Personalized EBM Antihypertensive Drug Prescriptions for Patients With Hypertension and Comorbidities in Everyday Clinical Practice

Outcome Measures

Primary Outcomes (1)

  • The percentage of personalized evidence-based medicine recommendations

    The percentage of personalized EBM recommendations acted on by clinicians for antihypertensive therapy in patients with comorbidities. All discrepancies between routine and CDSS-recommended treatment resulting in frame of guideline-based therapy and personalized EBM therapy will be adjudicated by core laboratory.

    3-year

Secondary Outcomes (3)

  • 3-year FU outcomes

    3-year

  • Quantify the performance of the CDSS (MedicBK) algorithm

    3-year

  • Predictors

    3-year

Study Arms (2)

By CDSS (MedicBK) Analysis

Drug: antihypertensive therapy

General practice

Drug: antihypertensive therapy

Interventions

antihypertensive therapyDRUG

Personalized evidence-based antihypertensive therapy in patients with comorbidities

By CDSS (MedicBK) AnalysisGeneral practice

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with hypertension and comorbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Evgeny Pokushalov

Novosibirsk, 630090, Russia

RECRUITING

Study Officials

  • Evgeny Pokushalov, Prof. MD PhD

    Center for New Medical Technologies, Novosibirsk, Russia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Evgeny Pokushalov, Prof. MD PhD

CONTACT

89139254858e.pokushalov@gmail.com

Svetlana Kozlova, MD

CONTACT

+79213360508senpolia@yandex.ru

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director for research and development

Study Record Dates

First Submitted

March 8, 2021

First Posted

March 10, 2021

Study Start

February 1, 2021

Primary Completion

March 30, 2021

Study Completion

March 30, 2021

Last Updated

March 11, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)