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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05901870
Other study ID # 03.005.?.34.1
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date August 12, 2023
Est. completion date December 2023

Study information

Verified date June 2023
Source I.M. Sechenov First Moscow State Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. All data will be collected via a Computer Assisted Telephone Interview (CATI).


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 2529
Est. completion date December 2023
Est. primary completion date September 11, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Questionnaire administration
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.

Locations

Country Name City State
Russian Federation I.M. Sechenov First Moscow State Medical University Moscow

Sponsors (2)

Lead Sponsor Collaborator
I.M. Sechenov First Moscow State Medical University Agency of Social Information St. Petersburg

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Upon enrollment
Primary 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). Upon enrollment
Primary 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. Upon enrollment
Primary 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". Upon enrollment
Primary 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. Upon enrollment
Primary 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. Upon enrollment
Primary 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. Upon enrollment
Primary Physical activity The frequency of physical activity and sedentary time will cover the physical activity section. Upon enrollment
Primary 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. Upon enrollment
Primary 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). Upon enrollment
Primary 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.
Upon enrollment
Secondary 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. Upon enrollment
Secondary 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. Upon enrollment
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