Quality of LifeSTARTNCT05561283
Evaluation of the Satisfaction and Relevance of Leadership Training for Residents
A study testing Self-questionnaires in people with Quality of Life and Medical Residents, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Health students are the future actors of the health system. They are exposed to many stressors in their journey. The quality of life of medical students is alarming worldwide: 11.1% of undergraduate and postgraduate residents reportedly have suicidal ideation and 27.2% have depressive symptoms. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Medical Residents
- What is being tested?
- Self-questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 14 Nov 2022to 18 Mar 2024
- Phase
- Interventional
- 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
Who may be able to join
- residents assigned to the Hospices Civils de Lyon
- Informed consent given by the resident
Who cannot join
- Pregnant women, women in labour or nursing mothers
- Persons deprived of their liberty by a judicial or administrative decision
- Persons under psychiatric care
- Persons of full age who are subject to a legal protection measure (guardianship, curatorship)
- Persons who are not affiliated to a social security scheme or who are beneficiaries of a similar scheme
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Satisfaction and Relevance of Leadership Training for Residents - START Study
Health students are the future actors of the health system. They are exposed to many stressors in their journey. The quality of life of medical students is alarming worldwide: 11.1% of undergraduate and postgraduate residents reportedly have suicidal ideation and 27.2% have depressive symptoms. In addition, 44.2% suffer from burn-out syndrome. In the third cycle, 28.8% suffer from depressive symptoms and 35.1% from burn-out syndrome. This finding is shared internationally among medical residents. Health professionals are facing a global problem which it is crucial to act.
At national level, a survey on the mental health of young doctors carried out in 2017 found, among the 7603 residents who responded a prevalence: 22.8% of depressive symptoms, 59.7% of anxiety symptoms, 23.4% of suicidal thoughts, including 5.0% in the month prior to the survey. In 2018, a French report on the quality of life of health by Dr Donata Marra highlighted a real malaise affecting residents and the need to intervene "for residents, for carers and for patients", through the implementation of specific recommendations. The proposal 6 of the report emphasises the prevention of psychosocial risks through educational interventions such as training in collaborative management. On a personal level, the aim is to the leadership of each individual, in terms of stress management, communication, cross-disciplinary skills or even the introduction of relational simulations in the teaching of an awareness of deviant behaviour and harassment. The stress factors are indeed multiple during health studies confrontation with death, competition, increasing responsibilities… Perceived stress has a negative impact on the quality of life and burnout. Effective stress management strategies could therefore help to improve the quality of life of residents.
Read more
In this context, the analysis of the literature highlights three main areas of intervention that could contribute to resident leadership in favour of their quality of life: stress management, healthy living and the construction of a professional identity.
The Junior Leadership programme for residents from the beginning of their professional formation designed to provide basic knowledge and skills in healthcare leadership and to develop cross-disciplinary skills. The aim is to provide the necessary support for the success of the resident's professional project by participating in the improvement of their quality of life and the prevention of psycho-social risks.
The study therefore propose to evaluate the feasibility of training in leadership and meditation on the satisfaction of resident.
- Conditions
- Quality of Life, Medical Residents
- Being tested
- Self-questionnaires
- Keywords
- leadership, meditation, residents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-questionnairesDiagnostic test
Self-questionnaires on satisfaction, burn-out, depression, anxiety, relational skills and sleep quality
| Study group | Role | What they receive |
|---|---|---|
| Cohort of residents | Experimental | Medical residents undergoing the leadership and meditation training Receives: Diagnostic Test: Self-questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the satisfaction on the Junior Leadership programme for residents evaluated by the questionnaire recommanded by the HAS
The satisfaction of the residents will be evaluated by a self-questionnaire according to model recommended by the Haute Autorité de Santé (HAS)and used in the framework of the SAMSEI programme (SAMSEI="Stratégies d'Apprentissage des Métiers de Santé en Environnement Immersif" that means in English "Learning Strategies for Healthcare Professions in an Immersive Environment") and the Lyon South Health Simulation Centre. The questionnaire will evaluate the interest, practical usefulness, density of information information, conformity with the objectives, the material conditions of the training, the activity of the participants and the motivation to continue the training.
Measured: At 4 months (at the end of the training that lasts around 4 months)
Secondary outcomes (8)
Change of proportion of burn-out evaluated the Maslach's burn-out inventory scale
The proportion of residents showing symptoms of burn-out will be assessed by the Maslach's burn-out inventory before training and 3 months, 6 months and 1 year after training.
Measured: Before training (baseline) and 3 months, 6 months and 1 year after training
Change int he presence of symptoms of anxiety and depression evaluated by the HADS scale
Anxiety and depression symptoms will be assessed by Hospital Anxiety and Depression Scale (HADS) before training and at 3 months, 6 months and 1 year after training.
Measured: Before training (baseline) and 3 months, 6 months and 1 year after training
Change of the real-life stress levels in the professional environment of residents evaluated by the Karasek scale
The stress of residents in their work environment will be assessed using the Karasek scale, which evaluates psychosocial risk factors at work before training and at 3 months, 6 months and and 1 year after the training
Measured: Before training (baseline) and 3 months, 6 months and 1 year after training
Change of relational skills evaluated by Cungi and Rey's communication scale
Caregivers' interpersonal skills will be assessed by Cungi and Rey's communication scale at 3 months, 6 months and 1 year after the training.
Measured: Before training (baseline) and 3 months, 6 months and 1 year after training
Change of sleep quality of the residents evaluated by the LEEDS scale
The sleep quality of the residents will be assessed by the LEEDS scale before training and at 3 months, 6 months and 1 year after training
Measured: Before training (baseline) and 3 months, 6 months and 1 year after training
Change of the use of psychoactive substances by residents collected by questionnaire
The use of psychoactive substances will be collected from residents before the training and at 3 months, 6 months and 1 year after the training
Measured: Before training (baseline) and 3 months, 6 months and 1 year after training
Change of the use of medical/psychological by residents collected by questionnaire
The use of medical/psychological support will be collected from residents before the training and at 3 months, 6 months and 1 year after the training.
Measured: Before training (baseline) and 3 months, 6 months and 1 year after training
Change of the number of days off for sikness collected by questionnaire
The number of days off sick will be collected from the residents before the training and at 3 months, 6 months and 1 year after the training.
Measured: Before training (baseline) and 3 months, 6 months and 1 year after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start14 Nov 2022
- Primary completion18 Mar 2024
- Study completion18 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561283
- Sponsor's protocol ID
- 69HCL21_1273
- Acronym
- START
- Status last verified
- May 2024
- First submitted
- 21 Sep 2022
- Last updated
- 7 May 2024
- 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 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Satisfaction and Relevance of Leadership Training for Residents - START Study
- ClinicalTrials.gov ID
- NCT05561283
- Acronym / sponsor ID
- START / 69HCL21_1273
- Conditions
- Quality of Life, Medical Residents
- Keywords
- leadership, meditation, residents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 18 Mar 2024 (actual)
- Study completion
- 18 Mar 2024 (actual)
- First posted
- 30 Sep 2022 (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.
Health students are the future actors of the health system. They are exposed to many stressors in their journey. The quality of life of medical students is alarming worldwide: 11.1% of undergraduate and postgraduate residents reportedly have suicidal ideation and 27.2% have depressive symptoms. In addition, 44.2% suffer from burn-out syndrome. In the third cycle, 28.8% suffer from depressive symptoms and 35.1% from burn-out syndrome. This finding is shared internationally among medical residents. Health professionals are facing a global problem which it is crucial to act.
At national level, a survey on the mental health of young doctors carried out in 2017 found, among the 7603 residents who responded a prevalence: 22.8% of depressive symptoms, 59.7% of anxiety symptoms, 23.4% of suicidal thoughts, including 5.0% in the month prior to the survey. In 2018, a French report on the quality of life of health by Dr Donata Marra highlighted a real malaise affecting residents and the need to intervene "for residents, for carers and for patients", through the implementation of specific recommendations. The proposal 6 of the report emphasises the prevention of psychosocial risks through educational interventions such as training in collaborative management. On a personal level, the aim is to the leadership of each individual, in terms of stress management, communication, cross-disciplinary skills or even the introduction of relational simulations in the teaching of an awareness of deviant behaviour and harassment. The stress factors are indeed multiple during health studies confrontation with death, competition, increasing responsibilities… Perceived stress has a negative impact on the quality of life and burnout. Effective stress management strategies could therefore help to improve the quality of life of residents.
In this context, the analysis of the literature highlights three main areas of intervention that could contribute to resident leadership in favour of their quality of life: stress management, healthy living and the construction of a professional identity.
The Junior Leadership programme for residents from the beginning of their professional formation designed to provide basic knowledge and skills in healthcare leadership and to develop cross-disciplinary skills. The aim is to provide the necessary support for the success of the resident's professional project by participating in the improvement of their quality of life and the prevention of psycho-social risks.
The study therefore propose to evaluate the feasibility of training in leadership and meditation on the satisfaction of resident.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort of residents | Experimental | Diagnostic Test: Self-questionnairesMedical residents undergoing the leadership and meditation training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- residents assigned to the Hospices Civils de Lyon
- Informed consent given by the resident
Key exclusion criteria (5 listed)
- Pregnant women, women in labour or nursing mothers
- Persons deprived of their liberty by a judicial or administrative decision
- Persons under psychiatric care
- Persons of full age who are subject to a legal protection measure (guardianship, curatorship)
- Persons who are not affiliated to a social security scheme or who are beneficiaries of a similar scheme
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 |
|---|---|---|
| Self-questionnairesSelf-questionnaires on satisfaction, burn-out, depression, anxiety, relational skills and sleep quality | Diagnostic test | Cohort of residents |
Primary outcome
Description of the satisfaction on the Junior Leadership programme for residents evaluated by the questionnaire recommanded by the HAS
Time frame: At 4 months (at the end of the training that lasts around 4 months)
The satisfaction of the residents will be evaluated by a self-questionnaire according to model recommended by the Haute Autorité de Santé (HAS)and used in the framework of the SAMSEI programme (SAMSEI="Stratégies d'Apprentissage des Métiers de Santé en Environnement Immersif" that means in English "Learning Strategies for Healthcare Professions in an Immersive Environment") and the Lyon South Health Simulation Centre. The questionnaire will evaluate the interest, practical usefulness, density of information information, conformity with the objectives, the material conditions of the training, the activity of the participants and the motivation to continue the training.
8 secondary outcomes
Change of proportion of burn-out evaluated the Maslach's burn-out inventory scale
Time frame: Before training (baseline) and 3 months, 6 months and 1 year after training
Change int he presence of symptoms of anxiety and depression evaluated by the HADS scale
Time frame: Before training (baseline) and 3 months, 6 months and 1 year after training
Change of the real-life stress levels in the professional environment of residents evaluated by the Karasek scale
Time frame: Before training (baseline) and 3 months, 6 months and 1 year after training
Change of relational skills evaluated by Cungi and Rey's communication scale
Time frame: Before training (baseline) and 3 months, 6 months and 1 year after training
Change of sleep quality of the residents evaluated by the LEEDS scale
Time frame: Before training (baseline) and 3 months, 6 months and 1 year after training
Change of the use of psychoactive substances by residents collected by questionnaire
Time frame: Before training (baseline) and 3 months, 6 months and 1 year after training
Change of the use of medical/psychological by residents collected by questionnaire
Time frame: Before training (baseline) and 3 months, 6 months and 1 year after training
Change of the number of days off for sikness collected by questionnaire
Time frame: Before training (baseline) and 3 months, 6 months and 1 year after training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-questionnaires in people with Quality of Life and Medical Residents, 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 7 May 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Description of the satisfaction on the Junior Leadership programme for residents evaluated by the questionnaire recommanded by the HAS (time frame: At 4 months (at the end of the training that lasts around 4 months)). 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 7 May 2024.