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Completed

NCT Number: NCT05367141

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

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).

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Arterial Hypertension Cardiovascular Diseases Heart Diseases Hypertension Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samara Regional Cardiology Dispansery

Samara, 443070, Russia

About this study

Hypertension and atrial fibrillation are 2 important public health priorities. There is a gap between evidence-based best management and actual clinical practice. To decrease this gap, clinical practice guidelines (CPGs), based on available evidence are employed. 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. The INTELLECT II trial is designed as a multicenter, cluster-randomized, single-blind, controlled study with blinded outcome assessment. Approximately 10 centers from Russia will be enrolled. Centers managing patients with symptomatic atrial fibrillation and/or hypertension will be randomized to either patient management with aid of CDSS ("MedicBK") or standard care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Compliance with AF/hypertension clinical practice guidelines

    Time frame: 1 month

    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

Secondary outcomes

  1. Total cardiovascular events

    Time frame: 6 months

    total stroke or systemic embolism, total coronary heart disease, major bleeding, recurrence of atrial fibrillation, hospitalization or death from congestive heart failure and other significant vascular deaths

  2. Total mortality

    Time frame: 6 months

    death from all causes

  3. total number of non-planing visits and hospitalization

    Time frame: 6 months

    non-planing hospitalizations, non-planning visits, urgent visits

Sponsors and collaborators

Lead sponsor

Samara Regional Cardiology Dispensary

Other

Collaborators

  • Medicbook LLC

Registry information

Official study title

Active (CDSS) Control Blinded Multicenter, Cluster-randomized Trial of the Adherence to Clinical Practice Guidelines Using the Clinical Decision Support System in Patients With Hypertension and Atrial Fibrillation (INTELLECT II Trial)

Acronym: INTELLECTII

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
May 10, 2022
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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