- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06159699
Telecommunication Technology-based Online Survey
December 18, 2023 updated by: Nina D. Anfinogenova, Tomsk National Research Medical Center of the Russian Academy of Sciences
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.
Study Overview
Status
Recruiting
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
2000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nina D Anfinogenova, PhD
- Phone Number: +73822554111
- Email: anfiyj@gmail.com
Study Locations
-
-
-
Tomsk, Russian Federation, 634012
- Recruiting
- Tomsk National Research Medical Center, Russian Academy of Sciences
-
Contact:
- Nina D Anfinogenova, PhD
- Phone Number: +73822554111
- Email: anfiyj@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
The participants of the study undergo the online survey at www.zdorov.tpu.ru and www.zdorov.expert.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Five years
|
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.
|
Five years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of polypharmacy (percent)
Time Frame: Five years
|
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
|
Incidence of MRI administration (percent)
Time Frame: Two years
|
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
|
Incidence of CT administration (percent)
Time Frame: Two years
|
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
|
Incidence of diagnostic ultrasound administration (percent)
Time Frame: Two years
|
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
|
Incidence of diagnostic X-ray administration (percent)
Time Frame: Two years
|
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
|
Incidence of scintigraphy administration (percent)
Time Frame: Two years
|
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
|
Incidence of chest fluoroscopy administration (percent)
Time Frame: Two years
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Nina D Anfinogenova, PhD, Tomsk NRMC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 2, 2022
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
November 28, 2023
First Submitted That Met QC Criteria
November 28, 2023
First Posted (Actual)
December 7, 2023
Study Record Updates
Last Update Posted (Actual)
December 20, 2023
Last Update Submitted That Met QC Criteria
December 18, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRI-248
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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