Clinical trial NCT06159699: Telecommunication Technology-based Online Survey
Official title: New Challenges for the Population on the Path to Achieving Active Longevity: an Online Survey of Respondents Using Telecommunication Technologies
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
Sponsor class: OTHER
First posted: 2023-12-07
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Nonstructured population aged 18 years and older willing to complete the entire questionnaire and signing the informed concent form.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* age of 18 years and older
* signing the informed concent form online
* completion of the entire questionnaire

Exclusion Criteria:

* age under 18 years
* refuse to sign the informed concent form

Primary outcomes:
measure: Incidence of serious drug-drug interactions (percent)
timeFrame: Five years
measure: Median number of serious drug-drug interactions (n)
timeFrame: Five years
Secondary outcomes:
measure: Incidence of polypharmacy (percent)
timeFrame: Five years
measure: Incidence of MRI administration (percent)
timeFrame: Two years
measure: Incidence of CT administration (percent)
timeFrame: Two years
measure: Incidence of diagnostic ultrasound administration (percent)
timeFrame: Two years
measure: Incidence of diagnostic X-ray administration (percent)
timeFrame: Two years
measure: Incidence of scintigraphy administration (percent)
timeFrame: Two years
measure: Incidence of chest fluoroscopy administration (percent)
timeFrame: Two years
measure: Clinically significant CYP2D6 gene polymorphisms
timeFrame: Two months
measure: Clinically significant ACE gene polymorphisms
timeFrame: Two months
measure: Clinically significant UGT1A1 gene polymorphisms
timeFrame: Two months
measure: Clinically significant CYP2C9 gene polymorphisms
timeFrame: Two months
measure: Clinically significant CYP2C19 gene polymorphisms
timeFrame: Two months
Other outcomes:
Locations:
city: Tomsk
country: Russian Federation
facility: Tomsk National Research Medical Center, Russian Academy of Sciences
Study officials:
affiliation: Tomsk NRMC
name: Nina D Anfinogenova, PhD
role: PRINCIPAL_INVESTIGATOR
References: