Telecommunication Technology-based Online Survey

COVID-19 Clinical Trial

Official title:

New Challenges for the Population on the Path to Achieving Active Longevity: an Online Survey of Respondents Using Telecommunication Technologies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06159699
• Other study ID #: CRI-248
• Status: Recruiting
• Start date: December 2, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: December 2023
• Source: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Contact: Nina D Anfinogenova, PhD
• Phone: +73822554111
• Email: anfiyj[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2026
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Drug Interactions
• Polypharmacy
• Risk Factors

Intervention

Other:
• Online Survey
The participants of the study undergo the online survey at www.zdorov.tpu.ru and www.zdorov.expert.

Locations

Country	Name	City	State
Russian Federation	Tomsk National Research Medical Center, Russian Academy of Sciences	Tomsk

Sponsors (1)

Lead Sponsor	Collaborator
Tomsk National Research Medical Center of the Russian Academy of Sciences

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Five years
Primary	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.	Five years
Secondary	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.	Five years
Secondary	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.	Two years
Secondary	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.	Two years
Secondary	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.	Two years
Secondary	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.	Two years
Secondary	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.	Two years
Secondary	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.	Two years