- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05561283
Evaluation of the Satisfaction and Relevance of Leadership Training for Residents (START)
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marion DOUPLAT, MD
- Phone Number: +33 04 78 86 28 54
- Email: marion.douplat@chu-lyon.fr
Study Contact Backup
- Name: Anne TERMOZ
- Phone Number: +33 04 27 85 63 00
- Email: anne.termoz@chu-lyon.fr
Study Locations
-
-
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Oullins, France, 69921
- Pôle de simulation en Santé de Lyon Sud (PL3S)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- residents assigned to the Hospices Civils de Lyon
- Informed consent given by the resident
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort of residents
Medical residents undergoing the leadership and meditation training
|
Self-questionnaires on satisfaction, burn-out, depression, anxiety, relational skills and sleep quality
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At 4 months (at the end of the training that lasts around 4 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
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
|
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.
|
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
|
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
|
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
|
Caregivers' interpersonal skills will be assessed by Cungi and Rey's communication scale at 3 months, 6 months and 1 year after the training.
|
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
|
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
|
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
|
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
|
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
|
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.
|
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
|
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.
|
Before training (baseline) and 3 months, 6 months and 1 year after training
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 69HCL21_1273
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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