Quality of Life Clinical Trial
Official title:
Selected Health and Quality of Life Indicators Among ITMO University Students, Faculty and Staff
| NCT number | NCT05394441 |
| Other study ID # | 922022/4.3.1 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 2, 2022 |
| Est. completion date | December 31, 2023 |
| Verified date | March 2024 |
| Source | ITMO University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This study assess various indicators of physical and mental health, quality of life, well-being and satisfaction among students, faculty and staff of ITMO University. Participants are invited to join the study via informational web-site. Several quality of life indicators are obtained via surveys and some blood samples are taken to assess health condition.
| Status | Completed |
| Enrollment | 830 |
| Est. completion date | December 31, 2023 |
| Est. primary completion date | March 31, 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 16 Years and older |
| Eligibility | Inclusion Criteria: - student, faculty or staff from ITMO University - participants, who signed informed consent and consent for data gathering - participants, who signed consent to enroll in following surveys and health check-ups Exclusion Criteria: - participants younger than 16 years old - participants with acute conditions distorting quality of life assessment - participants, who did not sign informed consent and consent for data gathering - participants, who did not sign consent to enroll in following surveys and health check-ups |
| Country | Name | City | State |
|---|---|---|---|
| Russian Federation | ITMO University | Saint Petersburg |
| Lead Sponsor | Collaborator |
|---|---|
| ITMO University |
Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cholesterol | Measured by A15 biochemical automatic analyzer (Biosystem, Spain) | 30 days | |
| Primary | Lipidogram | Measured by A15 biochemical automatic analyzer (Biosystem, Spain) | 30 days | |
| Primary | Glycohemoglobin | Measured by Architect c8000 | 30 days | |
| Primary | Distress | Global measure of distress based on questions about anxiety and depressive symptoms that a person has experienced in the most recent 4 week period measured by Kessler-10 questionnaire | 30 days | |
| Primary | Psychological well-being | Measured by Oxford Happiness Questionnaire (OHQ) | 30 days | |
| Primary | Health status and quality of life | Measured by EuroQOL-5 Dimension Questionnaire (EQ-5D-5L) | 30 days | |
| Primary | Nicotine dependence | Nicotine dependence across all nicotine product types including cigarettes and electronic cigarettes measured by The Penn State Nicotine Dependence Index | 30 days | |
| Primary | Diabetes risk score | The 10-year risk of type 2 diabetes mellitus (DM), including asymptomatic diabetes mellitus and impaired glucose tolerance (IGT) measured by The Finnish Diabetes Risk Score | 30 days | |
| Primary | Sleep quality and disturbances. | Measured by Pittsburgh Sleep Quality Index | 30 days | |
| Primary | Physical activity | The types of intensity of physical activity and sitting time that people do as part of their daily lives measured by International Physical Activity Questionnaire - Short Form | 30 days | |
| Primary | Emotional eating, external eating, and restrained eating behavior | Qualitative and quantitative assessment of eating disorders associated with overeating and accompanying obesity measured by Dutch Eating Behavior Questionnaire | 30 days | |
| Primary | Alcohol use | Problematic alcohol use, including possible alcohol use disorders measured by The Russian version of the Alcohol Use Disorders Identification Test (AUDIT) | 30 days | |
| Primary | Ischemic heart disease prediction | Measured by The Rose angina screening questionnaire | 30 days | |
| Primary | Retinopathy | Measured with non-mydriatic fundus camera | 30 days | |
| Primary | Ocular fundus condition | Measured with non-mydriatic fundus camera | 30 days |
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