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NCT05367141 | Completed | Atrial Fibrillation


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

Samara Regional Cardiology Dispensary

Information provided by (Responsible Party):

Prof. Dmitry Duplyakov FESC

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).

Condition or disease

Atrial Fibrillation

Arterial Hypertension

Intervention/treatment

CDSS ("MedicBK")

Phase

Not Applicable

Detailed Description:

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.}}

Study Type : Interventional
Estimated Enrollment : 282 participants
Masking : Single
Primary Purpose : Supportive Care
Official 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)
Actual Study Start Date : May 17, 2022
Estimated Primary Completion Date : December 24, 2022
Estimated Study Completion Date : August 22, 2023
Arm Intervention/treatment

Active Comparator: CDSS

patient management with aid of CDSS

No Intervention: standard which

patient management with standard care according to guidelines

Ages Eligible for Study: 18 Years to 90 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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

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

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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

Russian Federation,

Samara Regional Cardiology Dispensary

Samara, Russian Federation, 443070

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