Risk Factors at Chronic Non-communicable Diseases in People of Working Age (FORTUNE)

Objectives: to study the clinical and demographic characteristics of working age persons, to highlight the main factors of non-communicable diseases (NCDs), to identify NCDs with physical examination, laboratory tests, electrocardiography and ultrasound imaging, to develop a corporate prevention program for the company to reduce the risk of complications of NCDs.

Research stages:

1. Questionnaire to identify socio-demographic, behavioral, hereditary, psycho-emotional risk factors of NCDs
2. Laboratory tests (analysis of glucose and cholesterol in the capillary blood, detection of microalbuminuria), diagnostic tests (electrocardiography, and carotid artery ultrasound)
3. Evaluation of the results of questionnaires and surveys. Recommendations for lifestyle modification and follow-up in a local healthcare department

Study Overview

• Status: Enrolling by invitation
• Conditions: Chronic Non-communicable Disease
• Intervention / Treatment: Diagnostic test: electrocardiography; Diagnostic test: analysis for glucose and cholesterol in the capillary blood; Diagnostic test: detection of microalbumuria; Diagnostic test: heart ultrasound examination; Diagnostic test: carotid artery ultrasound examination

Detailed Description

Currently the emphasis in preventive medicine is also on health of the working population, which is a key state policy in the Russian Federation. Health of working citizens is an important factor in the development and safety of the production sector, but it is also the key to health and well-being of all other groups - children and older generations - that is, in fact, the fundamental factor for social development. Therefore, the integration of health-saving technologies into all areas of working life, including production and work activities, is particularly important. In today's world, it is very important that everyone actively participate in the preservation the health of the individual and its high awareness. Awareness of risk factors for chronic non-communicable diseases and measures prevention throughout life is an important part of a healthy society. Monitoring the health of working citizens allows to predict the problem and take the necessary measures in a timely manner.

In the Russian Federation, medical screening is a complex system, including medical examination by physicians of several specialties and application of the necessary methods of examination to identify chronic non-communicable diseases and their risk factors at an early stage that are the main cause of disability and premature mortality in the country's population, and also to form health status groups and provide recommendations for patients. The examination is carried out once every three years and includes a set of methods of advanced examination to identify early on the most likely chronic non-communicable disease for a given age and gender. Regular checkups are the most important mass and highly effective medical technology of health savings.

The work of carrying out regular preventive examinations and check-ups is carried out by primary health care. Often the quality of such work is limited by manpower shortages, technological and logistical barriers. In modern conditions, these obstacles can be overcome by using mobile systems that include modern digital diagnostic technologies, Allow for more in-depth investigation and identification of risk factors not covered by the standard examination protocol. This will increase the coverage and detection of risk factors, which is an important component of the health saving of the working population

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • National Medical Research Center for Therapy and Preventive Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

The study is planned to include all working citizens who meet the inclusion criteria and have come for preventive examination. In total, at least 2,000 people are planned to be included in the study. All participants will be given informed consent to participate in the clinical trial

Description

Inclusion Criteria:

• employees of the company
• persons without NCDs diagnosis and not receiving permanent medication
• residents of the region of the Russian Federation where a factory with permanent or temporary registration is located

Exclusion Criteria:

• refusal to sign informed consent
• any NCDs requiring constant medication
• active cancer
• pulmonary embolism
• valve defects of the heart (except secondary mitral regurgitation)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Persons without NCDs; Persons without known NCDs and not using any medication on a permanent basis

Diagnostic test: electrocardiography; 12 standard leads; Diagnostic test: analysis for glucose and cholesterol in the capillary blood; express test; Diagnostic test: detection of microalbumuria; express test; Diagnostic test: heart ultrasound examination; Ultrasound examination with Lumify Handheld S4-1 Phased Array Ultrasound (Philips); Diagnostic test: carotid artery ultrasound examination; Ultrasound examination with Lumify Handheld L12-4 Linear Array Ultrasound (Philips)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prevalence of NCDs risk factors	risk factors of NCDs based on survey results and diagnostic tests	on enrollment
prevalence of NCDs	diagnosed NCDs based on survey results, and diagnostic tests	on enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization	Urgent or emergent hospitalization during the visit if indicated	on enrollment

Collaborators and Investigators

• Sponsor: National Medical Research Center for Therapy and Preventive Medicine
• Investigators: Study Director: Olga Dzhioeva, MD, PhD, National Medical Research Center for Therapy and Preventive Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: February 1, 2025
• First Submitted That Met QC Criteria: February 1, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 1, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: obesity; overweight; asthma; smoking; alcohol consumption; microalbuminuria; hyperglycemia; environment; arterial hypertension; diabetes mellitus; dyslipidemia; chronic obstructive pulmonary disease; coronary heart disease; cerebrovascular disease; malignant tumors; unbalanced diet; hypodynamia
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Noncommunicable Diseases
• Other Study ID Numbers: 05-05/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No