Public HealthNCT05901870
Russian National Health Telephone Survey (RNHTS)
An observational study of Public Health, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial summary
Russian National Health Telephone Survey (RNHTS) is a public health surveillance study that assesses various health-related quality of life, health-related behavior, and health care utilization indicators on a representative sample of the adult Russian population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Public Health
- What is being tested?
- Questionnaire administration
- How many people
- 2,529 participants
- Where
- 1 siteRussia
- Study dates
- 12 Aug 2023to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult Russian residents are eligible for the survey.
Who may be able to join
- Respondents are aged 18 and above.
- Respondents provide informed consent via telephone at the beginning of the survey.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Russian National Health Telephone Survey (RNHTS): Health-Related Quality of Life, Health-Related Behaviors, Health Care Utilization
Russian National Health Telephone Survey (RNHTS) is a public health surveillance study that assesses various health-related quality of life, health-related behavior, and health care utilization indicators on a representative sample of the adult Russian population. All data will be collected via a Computer Assisted Telephone Interview (CATI).
Read the 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.
- Conditions
- Public Health
- Being tested
- Questionnaire administration
- Keywords
- health status, health-related quality of life, health-related behaviors, health care utilization, telephone survey, national health survey
- Medical subject headings
- Health Behavior, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire administrationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Russian Adults (18+) | Russian adults who meet the inclusion criteria (described below) will be participants of RNHTS. Receives: Other: Questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-assessed health status
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.
Measured: Upon enrollment
Quality of life indicator measured by the 3-level version of the EuroQol-5 Dimension questionnaire (EQ-5D-3L) - health profile (state)
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).
Measured: Upon enrollment
The visual analogue scale score (EQ-VAS)
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.
Measured: Upon enrollment
Disability and functional limitations according to the Washington Group Short Set on Functioning questionnaire (WG-SS)
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".
Measured: Upon enrollment
Body Mass Index (BMI)
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.
Measured: Upon enrollment
Smoking behaviour
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.
Measured: Upon enrollment
Alcohol consumption
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.
Measured: Upon enrollment
Physical activity
The frequency of physical activity and sedentary time will cover the physical activity section.
Measured: Upon enrollment
Health care utilisation and patient choice between public and private health care providers
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.
Measured: Upon enrollment
Satisfaction with health care services provided
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).
Measured: Upon enrollment
Nonreceipt of needed medical care and nonreceipt of needed prescription drugs
This outcome measure refers to three types of cases of unmet needs:
- Respondents will be surveyed about cases when they went to a health care provider but were refused services. If respondents report that such an instance occurred in the last 12 months, they will be asked to specify the reason for the refusal that they were given.
- Respondents will also be asked whether they wanted to seek help for some health problem but ultimately decided not to in the last 12 months. If respondents report deciding not to seek care, they will be asked to specify the reasons that guided their decision.
- Respondents will also be asked whether they were prescribed some medication but ultimately decided not to buy it in the last 12 months. If respondents report deciding not to buy prescribed drugs, they will be asked to specify the reasons that guided their decision.
Measured: Upon enrollment
Secondary outcomes (2)
Oral health
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.
Measured: Upon enrollment
Dental services utilisation
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.
Measured: Upon enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start12 Aug 2023
- Primary completion11 Sep 2023
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Public HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 2,529 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency of Social Information St. Petersburg
- Responsible party
- Sponsor
- Investigators
- Ekaterina Aleksandrova, Principal investigator, I.M. Sechenov First Moscow State Medical University (Sechenov University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05901870
- Sponsor's protocol ID
- 03.005.С.34.1
- Status last verified
- Jun 2023
- First submitted
- 1 Jun 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Russian National Health Telephone Survey (RNHTS): Health-Related Quality of Life, Health-Related Behaviors, Health Care Utilization
- ClinicalTrials.gov ID
- NCT05901870
- Acronym / sponsor ID
- 03.005.С.34.1
- Conditions
- Public Health
- Keywords
- health status, health-related quality of life, health-related behaviors, health care utilization, telephone survey, national health survey
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,529 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Collaborators
- Agency of Social Information St. Petersburg
- Study start
- 12 Aug 2023 (actual)
- Primary completion
- 11 Sep 2023 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 13 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Russian National Health Telephone Survey (RNHTS) is a public health surveillance study that assesses various health-related quality of life, health-related behavior, and health care utilization indicators on a representative sample of the adult Russian population. All data will be collected via a Computer Assisted Telephone Interview (CATI).
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Russian Adults (18+) | – | Other: Questionnaire administrationRussian adults who meet the inclusion criteria (described below) will be participants of RNHTS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult Russian residents are eligible for the survey.
Key inclusion criteria (2 listed)
- Respondents are aged 18 and above.
- Respondents provide informed consent via telephone at the beginning of the survey.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire administrationAll 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. | Other | Russian Adults (18+) |
Primary outcome
Self-assessed health status
Time frame: Upon enrollment
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.
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
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).
The visual analogue scale score (EQ-VAS)
Time frame: Upon enrollment
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.
Disability and functional limitations according to the Washington Group Short Set on Functioning questionnaire (WG-SS)
Time frame: Upon enrollment
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".
Body Mass Index (BMI)
Time frame: Upon enrollment
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.
Smoking behaviour
Time frame: Upon enrollment
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.
Alcohol consumption
Time frame: Upon enrollment
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.
Physical activity
Time frame: Upon enrollment
The frequency of physical activity and sedentary time will cover the physical activity section.
Health care utilisation and patient choice between public and private health care providers
Time frame: Upon enrollment
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.
Satisfaction with health care services provided
Time frame: Upon enrollment
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).
Nonreceipt of needed medical care and nonreceipt of needed prescription drugs
Time frame: Upon enrollment
This outcome measure refers to three types of cases of unmet needs: * Respondents will be surveyed about cases when they went to a health care provider but were refused services. If respondents report that such an instance occurred in the last 12 months, they will be asked to specify the reason for the refusal that they were given. * Respondents will also be asked whether they wanted to seek help for some health problem but ultimately decided not to in the last 12 months. If respondents report deciding not to seek care, they will be asked to specify the reasons that guided their decision. * Respondents will also be asked whether they were prescribed some medication but ultimately decided not to buy it in the last 12 months. If respondents report deciding not to buy prescribed drugs, they will be asked to specify the reasons that guided their decision.
2 secondary outcomes
Oral health
Time frame: Upon enrollment
Dental services utilisation
Time frame: Upon enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ekaterina Aleksandrova principal investigator
I.M. Sechenov First Moscow State Medical University (Sechenov University)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Public Health, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-assessed health status (time frame: Upon enrollment). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2023.