Risk FactorsNCT06159699
Telecommunication Technology-based Online Survey
An observational study of Risk Factors and Polypharmacy, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
Trial summary
The aim of this study is to identify and assess new health-associated risk factors, including clinical-pharmacological risk factors. The cohort is built using telecommunication approaches. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Risk Factors, Polypharmacy, Drug Interactions
- What is being tested?
- Online Survey and Genetic Testing
- How many people
- 2,000 participants
- Where
- 1 siteRussia
- Study dates
- 2 Dec 2022to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Nonstructured population aged 18 years and older willing to complete the entire questionnaire and signing the informed concent form.
Who may be able to join
- age of 18 years and older
- signing the informed concent form online
- completion of the entire questionnaire
Who cannot join
- age under 18 years
- refuse to sign the informed concent form
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Tomsk National Research Medical Center, Russian Academy of Sciences
Tomsk, 634012
Nina D Anfinogenova, PhD, +73822554111, anfiyj@gmail.com
About this study
Official title: New Challenges for the Population on the Path to Achieving Active Longevity: an Online Survey of Respondents Using Telecommunication Technologies
The aim of this study is to identify and assess new health-associated risk factors, including clinical-pharmacological risk factors. The cohort is built using telecommunication approaches. The associations between clinical-pharmacological, social, demographic, behavioral, and environmental characteristics will be assessed. The continuous depersonalized online survey is performed using the original informational resources in the form of specially designed web-site aimed at identification and assessment of population-based pharmacotherapy patterns including characteristics of self-medication, biologically active food supplement intake, polypharmacy, and adverse drug-drug interactions in the people residing in the ecological conditions of various regions of the country. The invitations to participate in the online survey are sent via the SMS messages using the SMS-Target tool provided by OOO T2 Mobile Company. The survey is performed online at www.zdorov.tpu.ru and www.zdorov.expert both specifically designed for questionnaire publication and data accumulation.
Read the detailed description
Polypharmacy-associated serious drug-drug interactions and adverse drug reactions may increase the risk of morbidity and mortality in the population, especially in cardiovascular patients. Insufficient patient compliance to treatment and potential self-medication overlap with behavioral, psychosocial, demographic, and environmental conditions and pose new challenges for the population striving to achieve active longevity. These issues have been especially relevant during and after the COVID-19 pandemic. The aim of this study is to identify and assess new health-associated risk factors, including clinical-pharmacological risk factors. Telecommunication approaches are used for the formation of study cohort. The associations between clinical-pharmacological, social, demographic, behavioral, and environmental characteristics of study cohort will be assessed. The continuous depersonalized online survey is performed using the original informational resource in the form of specially designed web-site aimed at identification and assessment of population-based pharmacotherapy patterns including characteristics of self-medication, biologically active food supplement intake, polypharmacy, and adverse drug-drug interactions in the people residing in the ecological conditions of various regions of the country. The acquired data may lay a foundation for the development decision support system for control of previously unrecognized or poorly recognized risk factors. The study will enroll as least 2000 respondents aged 18 years and older. The invitations to participate in the online survey are sent via the SMS messages using the SMS-Target tool provided by OOO T2 Mobile Company. The survey is performed online at www.zdorov.tpu.ru and www.zdorov.expert both specifically designed for questionnaire publication and data accumulation. Both websites have built-in functionality for downloading survey results in tabular format (.xls, .csv). All the respondents are required to sign the informed consent form electronically according to local legislation and international standards of ethical research. Considering that no physical medical examinations or interventions are involved in the study, and all data undergo complete depersonalization, participation in this study does not pose any risks for respondents. Financial support for the study is provided by the Russian Science Foundation (project No. 22-15-00313). Respondents will not be covered by insurance due to the non-interventional nature of the study.
- Conditions
- Risk Factors, Polypharmacy, Drug Interactions, Self Medication, COVID-19
- Being tested
- Online Survey, Genetic Testing
- Keywords
- Polypharmacy, Potential Drug-Drug Interactions, Self Medication, COVID-19, Medical Imaging, Environmental Risk Factors, Protracted Low-Dose-Rate Radiation Exposure
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online SurveyOther
Also called Telecommunication-Based Survey
The participants of the study undergo the online survey at www.zdorov.tpu.ru and www.zdorov.expert.
Genetic TestingDiagnostic test
Also called Genetic Polymorphisms of Drug-Metabolizing Enzymes
Genetic testing will be performed in subgroup of survey respondents willing to participate in the study of polymorphisms of genes involved in drug metabolism or affecting biological effects of medications including CYP2D6, ACE, UGT1A1, CYP2C9, and CYP2C19.
| Study group | Role | What they receive |
|---|---|---|
| Non-structured population | The respondent will represent the non-structured population of the Russian Federation invited to participate in the study using the SMS-Target tool provided by OOO T2 Mobile Company. Receives: Other: Online Survey; Diagnostic Test: Genetic Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of serious drug-drug interactions (percent)
Incidence of serious drug-drug interactions (DDIs) is assessed as a percentage (%) of completed survey questionnaires associated with serious DDIs relative to the size of respondent population.
Measured: Five years
Median number of serious drug-drug interactions (n)
Median number of serious drug-drug interactions is assessed per one completed survey questionnaire containing information on pharmacotherapy.
Measured: Five years
Secondary outcomes (12)
Incidence of polypharmacy (percent)
Polypharmacy refers to using five or more medications. Incidence of polypharmacy is assessed as a percentage (%) of completed survey questionnaires reporting polypharmacy relative to the size of respondent population.
Measured: Five years
Incidence of MRI administration (percent)
Incidence of magnetic resonance tomography (MRI) administration is assessed as a percentage (%) of completed survey questionnaires where respondents report the fact of undergoing MRI procedure for the past two years relative to the size of respondent population.
Measured: Two years
Incidence of CT administration (percent)
Incidence of computed tomography (CT) administration is assessed as a percentage (%) of completed survey questionnaires where respondents report the fact of undergoing CT procedure for the past two years relative to the size of respondent population.
Measured: Two years
Incidence of diagnostic ultrasound administration (percent)
Incidence of diagnostic ultrasound administration is assessed as a percentage (%) of completed survey questionnaires where respondents report the fact of undergoing ultrasonography procedure for the past two years relative to the size of respondent population.
Measured: Two years
Incidence of diagnostic X-ray administration (percent)
Incidence of diagnostic X-ray administration is assessed as a percentage (%) of completed survey questionnaires where respondents report the fact of undergoing X-ray for the past two years relative to the size of respondent population.
Measured: Two years
Incidence of scintigraphy administration (percent)
Incidence of scintigraphy administration is assessed as a percentage (%) of completed survey questionnaires where respondents report the fact of undergoing scintigraphy for the past two years relative to the size of respondent population.
Measured: Two years
Incidence of chest fluoroscopy administration (percent)
Incidence of chest fluoroscopy administration is assessed as a percentage (%) of completed survey questionnaires where respondents report the fact of undergoing chest fluoroscopy for the past two years relative to the size of respondent population.
Measured: Two years
Clinically significant CYP2D6 gene polymorphisms
Clinically significant CYP2D6 gene polymorphisms will be identified by diagnostic sequencing using EDTA whole blood.
Measured: Two months
Clinically significant ACE gene polymorphisms
Clinically significant ACE gene polymorphisms will be identified by real-time PCR with melting curve detection using EDTA whole blood.
Measured: Two months
Clinically significant UGT1A1 gene polymorphisms
Clinically significant UGT1A1 gene polymorphisms will be identified by real-time PCR with melting curve detection using EDTA whole blood.
Measured: Two months
Clinically significant CYP2C9 gene polymorphisms
Clinically significant CYP2C9 gene polymorphisms will be identified by real-time PCR with melting curve detection using EDTA whole blood.
Measured: Two months
Clinically significant CYP2C19 gene polymorphisms
Clinically significant CYP2C19 gene polymorphisms will be identified by real-time PCR with melting curve detection using EDTA whole blood.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start2 Dec 2022
- Primary completion1 Sep 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk FactorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nina D. Anfinogenova, Tomsk National Research Medical Center of the Russian Academy of Sciences
- Investigators
- Nina D Anfinogenova, PhD, Principal investigator, Tomsk NRMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159699
- Sponsor's protocol ID
- CRI-248
- Status last verified
- Jan 2026
- First submitted
- 28 Nov 2023
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Challenges for the Population on the Path to Achieving Active Longevity: an Online Survey of Respondents Using Telecommunication Technologies
- ClinicalTrials.gov ID
- NCT06159699
- Acronym / sponsor ID
- CRI-248
- Conditions
- Risk Factors, Polypharmacy, Drug Interactions, Self Medication, COVID-19
- Keywords
- Polypharmacy, Potential Drug-Drug Interactions, Self Medication, COVID-19, Medical Imaging, Environmental Risk Factors, Protracted Low-Dose-Rate Radiation Exposure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of SciencesUniversity, hospital or other
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 7 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to identify and assess new health-associated risk factors, including clinical-pharmacological risk factors. The cohort is built using telecommunication approaches. The associations between clinical-pharmacological, social, demographic, behavioral, and environmental characteristics will be assessed. The continuous depersonalized online survey is performed using the original informational resources in the form of specially designed web-site aimed at identification and assessment of population-based pharmacotherapy patterns including characteristics of self-medication, biologically active food supplement intake, polypharmacy, and adverse drug-drug interactions in the people residing in the ecological conditions of various regions of the country. The invitations to participate in the online survey are sent via the SMS messages using the SMS-Target tool provided by OOO T2 Mobile Company. The survey is performed online at www.zdorov.tpu.ru and www.zdorov.expert both specifically designed for questionnaire publication and data accumulation.
Detailed description
Polypharmacy-associated serious drug-drug interactions and adverse drug reactions may increase the risk of morbidity and mortality in the population, especially in cardiovascular patients. Insufficient patient compliance to treatment and potential self-medication overlap with behavioral, psychosocial, demographic, and environmental conditions and pose new challenges for the population striving to achieve active longevity. These issues have been especially relevant during and after the COVID-19 pandemic. The aim of this study is to identify and assess new health-associated risk factors, including clinical-pharmacological risk factors. Telecommunication approaches are used for the formation of study cohort. The associations between clinical-pharmacological, social, demographic, behavioral, and environmental characteristics of study cohort will be assessed. The continuous depersonalized online survey is performed using the original informational resource in the form of specially designed web-site aimed at identification and assessment of population-based pharmacotherapy patterns including characteristics of self-medication, biologically active food supplement intake, polypharmacy, and adverse drug-drug interactions in the people residing in the ecological conditions of various regions of the country. The acquired data may lay a foundation for the development decision support system for control of previously unrecognized or poorly recognized risk factors. The study will enroll as least 2000 respondents aged 18 years and older. The invitations to participate in the online survey are sent via the SMS messages using the SMS-Target tool provided by OOO T2 Mobile Company. The survey is performed online at www.zdorov.tpu.ru and www.zdorov.expert both specifically designed for questionnaire publication and data accumulation. Both websites have built-in functionality for downloading survey results in tabular format (.xls, .csv). All the respondents are required to sign the informed consent form electronically according to local legislation and international standards of ethical research. Considering that no physical medical examinations or interventions are involved in the study, and all data undergo complete depersonalization, participation in this study does not pose any risks for respondents. Financial support for the study is provided by the Russian Science Foundation (project No. 22-15-00313). Respondents will not be covered by insurance due to the non-interventional nature of the study.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-structured population | – | Other: Online Survey, Diagnostic Test: Genetic TestingThe respondent will represent the non-structured population of the Russian Federation invited to participate in the study using the SMS-Target tool provided by OOO T2 Mobile Company. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Nonstructured population aged 18 years and older willing to complete the entire questionnaire and signing the informed concent form.
Key inclusion criteria (3 listed)
- age of 18 years and older
- signing the informed concent form online
- completion of the entire questionnaire
Key exclusion criteria (2 listed)
- age under 18 years
- refuse to sign the informed concent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online SurveyAlso: Telecommunication-Based SurveyThe participants of the study undergo the online survey at www.zdorov.tpu.ru and www.zdorov.expert. | Other | Non-structured population |
| Genetic TestingAlso: Genetic Polymorphisms of Drug-Metabolizing EnzymesGenetic testing will be performed in subgroup of survey respondents willing to participate in the study of polymorphisms of genes involved in drug metabolism or affecting biological effects of medications including CYP2D6, ACE, UGT1A1, CYP2C9, and CYP2C19. | Diagnostic test | Non-structured population |
Primary outcome
Incidence of serious drug-drug interactions (percent)
Time frame: Five years
Incidence of serious drug-drug interactions (DDIs) is assessed as a percentage (%) of completed survey questionnaires associated with serious DDIs relative to the size of respondent population.
Median number of serious drug-drug interactions (n)
Time frame: Five years
Median number of serious drug-drug interactions is assessed per one completed survey questionnaire containing information on pharmacotherapy.
12 secondary outcomes
Incidence of polypharmacy (percent)
Time frame: Five years
Incidence of MRI administration (percent)
Time frame: Two years
Incidence of CT administration (percent)
Time frame: Two years
Incidence of diagnostic ultrasound administration (percent)
Time frame: Two years
Incidence of diagnostic X-ray administration (percent)
Time frame: Two years
Incidence of scintigraphy administration (percent)
Time frame: Two years
Incidence of chest fluoroscopy administration (percent)
Time frame: Two years
Clinically significant CYP2D6 gene polymorphisms
Time frame: Two months
Clinically significant ACE gene polymorphisms
Time frame: Two months
Clinically significant UGT1A1 gene polymorphisms
Time frame: Two months
Clinically significant CYP2C9 gene polymorphisms
Time frame: Two months
Clinically significant CYP2C19 gene polymorphisms
Time frame: Two months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nina D Anfinogenova, PhD principal investigator
Tomsk NRMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Risk Factors and Polypharmacy, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nina D Anfinogenova, PhD (+73822554111, anfiyj@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of serious drug-drug interactions (percent) (time frame: Five years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026; AzTrials last refreshed its copy on 27 Oct 2026.