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Идёт набор NCT06159699

Telecommunication Technology-based Online Survey

Наблюдательное Risk Factors Polypharmacy Drug Interactions Self Medication

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Online Survey, Genetic Testing.
Кому может быть актуально
Состояния в реестре: Risk Factors, Polypharmacy, Drug Interactions, Self Medication. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Россия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое Online Survey
    The participants of the study undergo the online survey at www.zdorov.tpu.ru and www.zdorov.expert.
  • Диагностический тест Genetic Testing
    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.

Первичные конечные точки

  • Incidence of serious drug-drug interactions (percent) [Срок оценки: Five years]
  • Median number of serious drug-drug interactions (n) [Срок оценки: Five years]
Вторичные конечные точки (12)
  • Incidence of polypharmacy (percent) [Срок оценки: Five years]
  • Incidence of MRI administration (percent) [Срок оценки: Two years]
  • Incidence of CT administration (percent) [Срок оценки: Two years]
  • Incidence of diagnostic ultrasound administration (percent) [Срок оценки: Two years]
  • Incidence of diagnostic X-ray administration (percent) [Срок оценки: Two years]
  • Incidence of scintigraphy administration (percent) [Срок оценки: Two years]
  • Incidence of chest fluoroscopy administration (percent) [Срок оценки: Two years]
  • Clinically significant CYP2D6 gene polymorphisms [Срок оценки: Two months]
  • Clinically significant ACE gene polymorphisms [Срок оценки: Two months]
  • Clinically significant UGT1A1 gene polymorphisms [Срок оценки: Two months]
  • Clinically significant CYP2C9 gene polymorphisms [Срок оценки: Two months]
  • Clinically significant CYP2C19 gene polymorphisms [Срок оценки: Two months]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Экологическое

Центры проведения

Россия · 1 центр
  • Tomsk National Research Medical Center, Russian Academy of Sciences — Tomsk

Идентификаторы

NCT: NCT06159699 · CRI-248

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗