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Clinical 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. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT06159699
Study type Observational
Source Tomsk National Research Medical Center of the Russian Academy of Sciences
Contact Nina D Anfinogenova, PhD
Phone +73822554111
Email anfiyj@gmail.com
Status Recruiting
Phase
Start date December 2, 2022
Completion date December 31, 2026

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