- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05901870
Russian National Health Telephone Survey (RNHTS)
Russian National Health Telephone Survey (RNHTS): Health-Related Quality of Life, Health-Related Behaviors, Health Care Utilization
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Russian National Health Telephone Survey (RNHTS) is the first public health surveillance study in Russia. The aim of RNTHS is to obtain unique representative data on health-related quality of life, health-related behaviors, and health care utilization indicators for the adult Russian population. Analysis of these indicators provides a detailed outlook on how health is associated with people's well-being, quality of life, and socio-demographic characteristics, which adds to official and aggregated statistics for Russia.
RNHTS consists of five sections. Section 1 includes socio-demographic characteristics of respondents such as their gender, age, marital status, education level, income level, employment status and location. Section 2 measures indicators of general health and health-related quality of life using the 3-level version of the EuroQol-5 Dimension questionnaire (EQ-5D-3L) and the Washington Group Short Set on Functioning questionnaire (WG-SS). Section 3 covers three health-related behaviours of respondents: smoking, drinking alcohol, and physical activity. Section 4 consists of questions about health care utilization in the last 12 months with an emphasis on patient choice between public and private health care. This section also measures how satisfied respondents were with health care services that they used, their unmet needs, and their health care avoidance. Section 5 is modifiable for each round (year) of RNHTS. This version of the protocol describes round 2 of RNHTS. In this round, Section 5 is devoted to measuring prevalence of arthritis in the adult Russian population and how it affects their quality of life as well as to learning about oral health and dental services utilization among Russian adults.
More than 2000 respondents will be randomly selected for RNHTS. All data will be collected using a Computer Assisted Telephone Interview (CATI) system, which allows real-time data capture and consolidation. All interviews will be conducted anonymously. The telephone survey will be conducted by Agency of Social Information St. Petersburg (ASI St. Petersburg). RNHTS data will be analysed using statistical analysis methods which will be presented using summary tables (summary statistics, contingency tables, frequency distributions), correlation coefficients, and estimates of regression models (coefficients, odds ratios, marginal effects). The results of statistical analysis will be compiled in one report with authors' comments on the findings.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Moscow, Russian Federation
- I.M. Sechenov First Moscow State Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Respondents are aged 18 and above.
- Respondents provide informed consent via telephone at the beginning of the survey.
Exclusion Criteria:
- Respondents refuse to provide informed consent.
- Respondents are severely ill or too frail to participate.
- Respondents have cognitive problems.
- Respondents have hearing or speaking problems.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Russian Adults (18+)
Russian adults who meet the inclusion criteria (described below) will be participants of RNHTS.
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All study participants will be surveyed with the questionnaire, which includes such instruments as EQ-5D-3L and WG-SS, to assess their health-related quality of life, health-related behavior, and health care utilization indicators.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-assessed health status
Time Frame: Upon enrollment
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Respondents will be asked to rate their health with the "in general, would you say that your health is excellent, very good, good, fair, or poor?" question.
The answer that they choose represents their self-assessed (self-rated) health status.
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Upon enrollment
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Quality of life indicator measured by the 3-level version of the EuroQol-5 Dimension questionnaire (EQ-5D-3L) - health profile (state)
Time Frame: Upon enrollment
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The EQ-5D-3L questionnaire consists of 5 questions in 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
In the 3-level version of the questionnaire, each domain has 3 levels.
The 5 answers to the 5 questions are combined into a 5-digit number that describes the patients' health profile (state).
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Upon enrollment
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The visual analogue scale score (EQ-VAS)
Time Frame: Upon enrollment
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The EQ-VAS records the patients' self rated-health on a scale from 0 to 100, where 0 = the worst imaginable health and 100 = the best imaginable health.
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Upon enrollment
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Disability and functional limitations according to the Washington Group Short Set on Functioning questionnaire (WG-SS)
Time Frame: Upon enrollment
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The WG-SS questionnaire is comprised of 6 questions about 6 core functional domains: seeing, hearing, walking, cognition, self-care, and communication.
Each question has four response categories: " no difficulty", " some difficulty", "a lot of difficulty", "cannot do it at all".
Disability is identified for individuals whose answer to at least one of the questions is "have a lot of difficulty" or "cannot do at all".
Presence of functional limitations is also determined within each domain for each person if their answer to a question about the domain is either "have a lot of difficulty" or "cannot do at all".
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Upon enrollment
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Body Mass Index (BMI)
Time Frame: Upon enrollment
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Self-reported height (in meters) and self-reported weight (in kilograms) will be combined to measure BMI as a person's weight divided by the square of their height.
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Upon enrollment
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Smoking behaviour
Time Frame: Upon enrollment
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Respondents will be asked whether they are current smokers or not, and if so, they will be questioned about smoking devices they use, their smoking frequency, intensity of smoking, smoking history and intentions to quit smoking.
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Upon enrollment
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Alcohol consumption
Time Frame: Upon enrollment
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Respondents will be asked whether they consume alcoholic beverages or not, and if so, they will be asked about the volume of consumed alcoholic beverages.
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Upon enrollment
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Physical activity
Time Frame: Upon enrollment
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The frequency of physical activity and sedentary time will cover the physical activity section.
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Upon enrollment
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Health care utilisation and patient choice between public and private health care providers
Time Frame: Upon enrollment
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Respondents will be asked whether they visited a health care provider in the last 12 months.
They will be asked to specify whether they chose to go to a public health care provider, to a private health care provider or whether they went to both types of providers.
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Upon enrollment
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Satisfaction with health care services provided
Time Frame: Upon enrollment
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Respondents will be asked 4 questions about their satisfaction with their most recent visit to a health care provider in the last 12 months.
They will be asked to rate how clear their doctor's explanation of their health problem was on a 5-level scale, how clear the doctor's explanation of their treatment options was on a 5-level scale, whether they trusted their doctor (fully trusted, partially trusted, or did not trust at all), and whether they would choose to get the same health care service at the same facility again if they had to (yes/no question).
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Upon enrollment
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Nonreceipt of needed medical care and nonreceipt of needed prescription drugs
Time Frame: Upon enrollment
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This outcome measure refers to three types of cases of unmet needs:
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Upon enrollment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oral health
Time Frame: Upon enrollment
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Respondents will be asked to rate their oral health with the "in general, would you say that your oral health is excellent, very good, good, fair, or poor?" question.
Respondents will also be questioned about practices they use for healthy teeth and gums.
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Upon enrollment
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Dental services utilisation
Time Frame: Upon enrollment
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Respondents will be asked when they last visited a dental care practitioner.
They will be asked to specify where they chose to go: to a public dental care practitioner or to a private dental care practitioner.
Respondents will be asked whether they wanted to seek help for dental problems but ultimately decided not to go to a dental care practitioner in the last 12 months.
If respondents report deciding not to seek dental care, they will be asked to specify the reasons that guided their decision.
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Upon enrollment
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ekaterina Aleksandrova, I.M. Sechenov First Moscow State Medical University (Sechenov University)
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 03.005.С.34.1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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