Improvement Adherence to Clinical Practice Guidelines Using the Clinical Decision Support System in Patients With Hypertension and Atrial Fibrillation

NCT05367141 | Completed

• 1 other identifier: SamaraRCD
• Study Type: interventional
• Target: 282
• Locations: 1 country
• Sites: 1

Brief Summary

The Clinical Decision Support Systems (CDSS) based on real clinical data and its own algorithms can help to make the right choice according to guidelines. The goal of the INTELLECT II study is to investigate treatment adherence to guidelines/science-based medicine and its impact on patient outcomes into two groups of doctors, clinical centers with standard care of treatment (control), and clinical centers using CDSS (active).

Conditions

Atrial Fibrillation; Arterial Hypertension

Keywords

clinical practice guidelines; Clinical Decision Support Systems; adherence to guidelines; evidence-based medicine

Outcome Measures

Primary Outcomes (1)

• Compliance with AF/hypertension clinical practice guidelines

  number of patients treated in accordance with current ESC clinical guidelines for management atrial fibrillation evaluated by independent professionals compared with Clinical decision support system MedicBK

  1 month

Secondary Outcomes (3)

• Total cardiovascular events

  6 months

• Total mortality

  6 months

• total number of non-planing visits and hospitalization

  6 months

Study Arms (2)

CDSS

ACTIVE COMPARATOR

patient management with aid of CDSS

Other: CDSS ("MedicBK")

standart care

NO INTERVENTION

patient management with standard care according to guidelines

Interventions

CDSS ("MedicBK") OTHER

Clinical decision support system ("MedicBK") is a computer-based program that analyzes published evidence and provides prompts and reminders to assist health care providers in implementing clinical guidelines and science-based medicine at the point of care.

CDSS

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Inability to adhere to study procedures
• Severe heart-valve disorder
• Stroke within 14 days or severe stroke within 6 months before screening
• Active bleedings
• Thyroid dysfunction
• Pregnancy
• Secondary hypertension

Sponsors & Collaborators

• Samara Regional Cardiology Dispensary: lead
• Medicbook LLC: collaborator

Study Sites (1)

Samara Regional Cardiology Dispansery

Samara, 443070, Russia

Location

Related Publications (1)

• Duplyakov D.V., Shebonkina D.A., Uranov A.E., Mikheenko I.L., Astrakova K.S., Gartung A.A., Adonina E.V., Tukhbatova A.A., Kuzmin V.P., Fedorova G.A., Gabidullova D.A., Skuratova M.A., Shechovtsova T.A., Losik D.V. Optimizing compliance with clinical guidelines using a clinical decision support system in patients with hypertension and atrial fibrillation in real-world practice: a cluster-randomized comparative study INTELLECT-2. Russian Journal of Cardiology. 2025;30(12):6365. (In Russ.) https://doi.org/10.15829/1560-4071-2025-6365. EDN: OKIRDC

  RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Atrial Fibrillation; Hypertension

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. Prof. Dmitry Duplyakov M.D.,Ph.D.

Model Details: multicenter, cluster-randomized, single-blind, controlled study with blinded outcome assessment.

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: May 10, 2022
• Study Start: May 17, 2022
• Primary Completion: December 24, 2022
• Study Completion: August 22, 2023
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)