HealthyPOSITIVENCT04108767
Innovative and Transdisciplinary Observation Program for the Quality of Life of Health Students
An observational study of Healthy, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Scientific context: Students' quality of life reflects the general health of students, in connection with the studies themselves, but also with physical, biological, social, cultural, and psychological determinants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Answer to standardized questionnaires in quality of life, health, lifestyle and behaviors
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2019to Aug 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study target the exhaustivity of the eligible population since all students are concerned by the mandatory visit.
Who may be able to join
- Adult (> 18 years)
- Enrolled in 3rd year of health study (Medicine, pharmacy, Institute of Rehabilitation Sciences and Techniques, odontology, maieutic) at the UCBL
- Participation at the required medical consultation at the college Health Department of UCBL
Who cannot join
- Lack of comprehension of the French language
- Implementation of protective measures
- Erasmus program
Trial locations and contacts
1 site in 1 country.
About this study
Scientific context: Students' quality of life reflects the general health of students, in connection with the studies themselves, but also with physical, biological, social, cultural, and psychological determinants. Indeed, students are young adults exposed to a complex period composed of transitions in different spheres of their life: housing, domestic tasks, social learning, lifestyle choices, etc. In addition to this, students in medical and health sciences have to face with stress due to a demanding training and exposure to the hospital world. According to the Haute Autorité de Santé (HAS), health professionals in activity or in training are identified as a "population at risk historically identified."
The studies on stress and psychological disorders, in medical students, are considerably documented on the international level and the incidence of various psychic problems (depressive state, suicidal ideas ...) and behavioural (food behaviours, addictive behaviours ...) has been shown to be predominant in this population. However, no studies have been conducted on aspects like self-esteem, self-efficacy and extracurricular activities. In this sense, it may be interesting to match quality of life of health students in Lyon compared to the results of the other studies carried out in France, and to have a global approach of the factors influencing quality of life, with identification of factors that are potentially harmful, but also beneficial to the global health. This study will also compare the results according to the different health sectors such as medicine, pharmacy, maieutic, odontology, and sciences of rehabilitation.
Read more
Research hypothesis: the study hypothesis is that description of the quality of life and, self-efficacy, self-esteem, nutrition, anxiety, physical activity, sleep quality, and addiction parameters in health student will better characterize student's issues in order to propose an appropriate intervention to improve their global health.
The study is an observational, cross sectional and monocentric study conducted among the population of students of the Lyon 1 University in the health science field on a 9 months period.
- Conditions
- Healthy
- Being tested
- Answer to standardized questionnaires in quality of life, health, lifestyle and behaviors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Answer to standardized questionnaires in quality of life, health, lifestyle and behaviorsBehavioural
The cross-sectional study will be conducted in all students in health sciences in 3rd year enrolled at the University Claude Bernard Lyon 1 (UCBL) and participating at the required medical consultation at the college Health Department of UCBL, over a period of 9 months.
The self-questionnaires will be completed by the students during the mandatory medical preventive visit at the university health center.
All dimensions investigated by the questionnaire are usually questioned by the caregivers during the consultation as part of the usual follow-up of students.
| Study group | Role | What they receive |
|---|---|---|
| Health students enrolled in the 3rd year at the University Cla | Health students enrolled in the 3rd year at the University Claude Bernard Lyon 1, aged over 18 years. Receives: Behavioral: Answer to standardized questionnaires in quality of life, health, lifestyle and behaviors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health student's quality of life: WHOQOL BREF questionnaire
The quality of life will be evaluated by the WHOQOL BREF questionnaire (Caria et al, 1995, Baumann et al, 2010) consisting of 26 items exploring physical health (7 items), psychological health (6 items), social relations (3 items), environment (8 items) and the quality of life related to health attesting to the overall satisfaction (2 items). Subject responses are collected using a Likert scale, scored from 1 to 5, summed and converted to a scale of 0 (poor quality of life) to 100 (good quality of life).
Measured: Month 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study startNov 2019 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionAug 2020 (estimated)
Why it stopped: We were not able to conduct this study, in fact we opened the participating center and the confinement arrived a few days later. Since then, the organization of the students' follow-up has changed and made the study as it was thought obsolete.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie Haesebaert, MD, Study director, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04108767
- Sponsor's protocol ID
- 69HCL19_0398
- Acronym
- POSITIVE
- Status last verified
- Mar 2023
- First submitted
- 26 Sep 2019
- Last updated
- 14 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative and Transdisciplinary Observation Program for the Quality of Life of Health Students
- ClinicalTrials.gov ID
- NCT04108767
- Acronym / sponsor ID
- POSITIVE / 69HCL19_0398
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: We were not able to conduct this study, in fact we opened the participating center and the confinement arrived a few days later. Since then, the organization of the students' follow-up has changed and made the study as it was thought obsolete.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Nov 2019 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 30 Sep 2019 (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.
Scientific context: Students' quality of life reflects the general health of students, in connection with the studies themselves, but also with physical, biological, social, cultural, and psychological determinants. Indeed, students are young adults exposed to a complex period composed of transitions in different spheres of their life: housing, domestic tasks, social learning, lifestyle choices, etc. In addition to this, students in medical and health sciences have to face with stress due to a demanding training and exposure to the hospital world. According to the Haute Autorité de Santé (HAS), health professionals in activity or in training are identified as a "population at risk historically identified."
The studies on stress and psychological disorders, in medical students, are considerably documented on the international level and the incidence of various psychic problems (depressive state, suicidal ideas ...) and behavioural (food behaviours, addictive behaviours ...) has been shown to be predominant in this population. However, no studies have been conducted on aspects like self-esteem, self-efficacy and extracurricular activities. In this sense, it may be interesting to match quality of life of health students in Lyon compared to the results of the other studies carried out in France, and to have a global approach of the factors influencing quality of life, with identification of factors that are potentially harmful, but also beneficial to the global health. This study will also compare the results according to the different health sectors such as medicine, pharmacy, maieutic, odontology, and sciences of rehabilitation.
Research hypothesis: the study hypothesis is that description of the quality of life and, self-efficacy, self-esteem, nutrition, anxiety, physical activity, sleep quality, and addiction parameters in health student will better characterize student's issues in order to propose an appropriate intervention to improve their global health.
The study is an observational, cross sectional and monocentric study conducted among the population of students of the Lyon 1 University in the health science field on a 9 months period.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health students enrolled in the 3rd year at the University Cla | – | Behavioral: Answer to standardized questionnaires in quality of life, health, lifestyle and behaviorsHealth students enrolled in the 3rd year at the University Claude Bernard Lyon 1, aged over 18 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study target the exhaustivity of the eligible population since all students are concerned by the mandatory visit.
Key inclusion criteria (3 listed)
- Adult (> 18 years)
- Enrolled in 3rd year of health study (Medicine, pharmacy, Institute of Rehabilitation Sciences and Techniques, odontology, maieutic) at the UCBL
- Participation at the required medical consultation at the college Health Department of UCBL
Key exclusion criteria (3 listed)
- Lack of comprehension of the French language
- Implementation of protective measures
- Erasmus program
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 |
|---|---|---|
| Answer to standardized questionnaires in quality of life, health, lifestyle and behaviorsThe cross-sectional study will be conducted in all students in health sciences in 3rd year enrolled at the University Claude Bernard Lyon 1 (UCBL) and participating at the required medical consultation at the college Health Department of UCBL, over a period of 9 months. The self-questionnaires will be completed by the students during the mandatory medical preventive visit at the university health center. All dimensions investigated by the questionnaire are usually questioned by the caregivers during the consultation as part of the usual follow-up of students. | Behavioural | Health students enrolled in the 3rd year at the University Cla |
Primary outcome
Health student's quality of life: WHOQOL BREF questionnaire
Time frame: Month 9
The quality of life will be evaluated by the WHOQOL BREF questionnaire (Caria et al, 1995, Baumann et al, 2010) consisting of 26 items exploring physical health (7 items), psychological health (6 items), social relations (3 items), environment (8 items) and the quality of life related to health attesting to the overall satisfaction (2 items). Subject responses are collected using a Likert scale, scored from 1 to 5, summed and converted to a scale of 0 (poor quality of life) to 100 (good quality of life).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Julie Haesebaert, MD study director
Hospices Civils de Lyon
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 Healthy, run by Hospices Civils de Lyon at 1 site in France.
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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 14 Mar 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 France. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Health student's quality of life: WHOQOL BREF questionnaire (time frame: Month 9). 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 14 Mar 2023.