Clinical trial NCT04564118: A Retrospective Analysis of the Adherence to Clinical Practice Guidelines Using the "MedicBK" Digital Platform in Patients With Hypertension and Atrial Fibrillation
Official title: A Retrospective Analysis of the Adherence to Clinical Practice Guidelines Using the "MedicBK" Digital Platform in Patients With Hypertension and Atrial Fibrillation (the INTELLECT Trial)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Arterial Hypertension
Keywords: atrial fibrillation
arterial hypertension
digital medicine
Clinical Decision Support System
Lead sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Sponsor class: OTHER
Collaborators: name: Medicbook LLC
First posted: 2020-09-25
Enrollment: 191
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with nonvalvular atrial fibrillation and essential hypertension having indications for therapy according to European guidelines

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.

Detailed description: There is a lot of data from registries about poor adherence to guidelines. It is connected with a problem that patients usually have a lot of comorbidities and physicians need to know сonsequently the huge number of medications and combinations. It is very difficult to decide quickly according to available data from libraries like PubMed. The Clinical Decision Support Systems (CDSS) based on real clinical data and its own Artificial Intelligence 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.

Two groups of experts (cardiologists with clinical practice for more than 5 years) will be participating in the trial.

Using main characteristics from EMC the first group of experts will put this data into MedicBK platform and assess retrospective treatment. The next blinded group of experts will perform prescriptions using MedicBK algorithms based on current guidelines and data from available clinical trials. The main hypothesis is the use Clinical Decision Support Systems (CDSS) better than current clinical practice. This option can help to make the right choice of medical combination based on main patient's clinical characteristics

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Valvular cause of atrial fibrillation
2. GFR less than 30 ml / min
3. Active liver disease
4. Acute coronary syndrome
5. The presence of thyroid diseases as a cause of atrial fibrillation
6. Secondary arterial hypertension

Primary outcomes:
measure: Assessment of AF/AH treatment guidelines compliance
timeFrame: 1 MONTH
Secondary outcomes:
measure: Assessment of MedicBK programme
timeFrame: 1 MONTH
Other outcomes:
Locations:
city: Saint-petersburg
country: Russian Federation
facility: V.A. Almazov Fnmrc
Study officials:
References: