xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05974735</url>
    </required_header>
    <id_info>
      <org_study_id>PRO-0038</org_study_id>
      <nct_id>NCT05974735</nct_id>
    </id_info>
    <brief_title>Adaptability to Stress of Healthcare Workers in the 8th Arrondissement</brief_title>
    <acronym>ASTRE</acronym>
    <official_title>Adaptability to Stress of Healthcare Workers in the 8th Arrondissement - Evaluation of Stress Perceived by Healthcare Professionals and Workers. Real-life Prospective Study.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>CPTS Paris 8</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>ICUREsearch</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>CPTS Paris 8</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Participants will be selected according to their affiliation with the Paris 8 CPTS. They will&#xD;
        be asked to complete a series of self-questionnaires to determine their stress levels and&#xD;
        lifestyle habits. These tests will be used to define a wellness pathway for each participant&#xD;
        in order to reduce the stress they feel at work. These wellness pathways are based around 4&#xD;
        distinct themes:&#xD;
  &#xD;
          -  Diet, nutrition and micronutrition&#xD;
  &#xD;
          -  Physical activity&#xD;
  &#xD;
          -  Sleep&#xD;
  &#xD;
          -  Stress and wellness. Participants will be follow-up at 3 and 6 months by means of&#xD;
             self-questionnaires and advice on the programme.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">July 2024</completion_date>
    <primary_completion_date type="Anticipated">July 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Evaluate the 3-month effectiveness of a well-being programme in improving stress management among healthcare professionals and workers with moderate stress.</measure>
      <time_frame>3 Months</time_frame>
      <description>Changes in the Perceived Stress Scale (PSS) score at 3 months after the SMS setting up the wellness pathway. The PSS is a score based on the sum of the values assigned to each response of 10 different items. The minimum score is 0 and the maximum score is 50. The higher the score, the more stressed the respondent is.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Evaluate the effectiveness of a well-being programme in improving stress management in healthcare professionals and workers with moderate stress at 6 months</measure>
      <time_frame>6 Months</time_frame>
      <description>Change in the Perceived Stress Scale (PSS) at 6 months from the SMS used to set up the wellness pathway. The PSS is a score based on the sum of the values assigned to each response of 10 different items. The minimum score is 0 and the maximum score is 50. The higher the score, the more stressed the respondent is.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluate the effectiveness of a well-being programme in improving the lifestyle habits of healthcare professionals and workers at 3 and 6 months</measure>
      <time_frame>3 and 6 Months</time_frame>
      <description>Evolution of the score obtained in the Lifestyle Questionnaire at 3 and 6 months after the SMS for the implementation of the wellness pathway. The Lifestyle Questionnaireis a score based on the assignment of a score for 4 health risk domains: Stress, Diet, Physical Activity and Sleep. The minimum score is 0 and the maximum score is 100 for each of the 4 items. The lower the score, the more the respondent to the questionnaire has a risk profile.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Compare the effectiveness of a well-being programme in improving stress management among healthcare professionals and workers, depending on their job</measure>
      <time_frame>3 and 6 Months</time_frame>
      <description>Changes in the Perceived Stress Scale (PSS) according to the professions of the healthcare professionals. The PSS is a score based on the sum of the values assigned to each response of 10 different items. The minimum score is 0 and the maximum score is 50. The higher the score, the more stressed the respondent is.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Observe the acceptability to healthcare professionals and workers of setting up a well-being programme</measure>
      <time_frame>3 and 6 Months</time_frame>
      <description>The participation rate of the participants will be collected through a series of closed questions with multiple choice answers on the type of course taken and the dates of the follow-ups. The satisfaction rate of the participants' well-being journey will be collected through a closed question with a dichotomous answer of the Yes / No type.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Occupational Stress</condition>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Wellness trail</intervention_name>
      <description>Setting up wellness trails based on four distinct themes:&#xD;
  Food, Nutrition and Micronutrition&#xD;
  Physical activity&#xD;
  Sleep&#xD;
  Stress and well-being</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Health professionals and actors affiliated to the Communauté professionnelle territoriale&#xD;
          de santé (CPTS) Paris 8.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  People of legal age&#xD;
  &#xD;
            -  Health professionals and players from the CPTS Paris 8 association:&#xD;
  &#xD;
                 -  Pharmacist,&#xD;
  &#xD;
                 -  Doctor&#xD;
  &#xD;
                 -  Midwife&#xD;
  &#xD;
                 -  Physiotherapist,&#xD;
  &#xD;
                 -  Dentist,&#xD;
  &#xD;
                 -  Nurse,&#xD;
  &#xD;
                 -  Pharmacy assistant,&#xD;
  &#xD;
                 -  Dietician-nutritionist,&#xD;
  &#xD;
                 -  Speech therapist,&#xD;
  &#xD;
                 -  Chiropodist,&#xD;
  &#xD;
                 -  Adapted physical activity teacher,&#xD;
  &#xD;
                 -  Medical secretary,&#xD;
  &#xD;
                 -  Other health service staff (maintenance, reception, general services and IT&#xD;
                    staff).&#xD;
  &#xD;
            -  Persons having given their non-opposition to participate in the study.&#xD;
  &#xD;
            -  Persons affiliated to a social security scheme or beneficiaries of such a scheme&#xD;
               (article L1121-11)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  People already following a wellness programme.&#xD;
  &#xD;
            -  People undergoing treatment for stress prescribed by a doctor.&#xD;
  &#xD;
            -  People on sick leave or long-term leave who are no longer at work and who cannot be&#xD;
               included in the study.&#xD;
  &#xD;
            -  People with a poor understanding of spoken and/or written French.&#xD;
  &#xD;
            -  Vulnerable persons in accordance with article L1121-6 of the CSP.&#xD;
  &#xD;
            -  Persons subject to a legal protection measure (guardianship, curatorship) or unable to&#xD;
               express their consent/non-opposition in accordance with article L1121-8 of the CSP or&#xD;
               under court protection in accordance with article L1122-2 of the CSP.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Eric MYON</last_name>
      <role>Principal Investigator</role>
      <affiliation>CPTS Paris 8</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Eric MYON, Doctor</last_name>
      <phone>01.48.74.74.91</phone>
      <email>eric_myon@yahoo.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Myriam HASSANI</last_name>
      <phone>07.88.67.41.68</phone>
      <email>cpts.paris8@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>CPTS Paris 8</name>
        <address>
          <city>Paris</city>
          <zip>75008</zip>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>professionals and actors health</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Occupational Stress</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05974735
  org study id: PRO-0038
  nct id: NCT05974735
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Participants will be selected according to their affiliation with the Paris 8 CPTS. They will
        be asked to complete a series of self-questionnaires to determine their stress levels and
        lifestyle habits. These tests will be used to define a wellness pathway for each participant
        in order to reduce the stress they feel at work. These wellness pathways are based around 4
        distinct themes:
  
          -  Diet, nutrition and micronutrition
  
          -  Physical activity
  
          -  Sleep
  
          -  Stress and wellness. Participants will be follow-up at 3 and 6 months by means of
             self-questionnaires and advice on the programme.
  observational model: Cohort
  time perspective: Prospective
  measure: Evaluate the 3-month effectiveness of a well-being programme in improving stress management among healthcare professionals and workers with moderate stress.
  time frame: 3 Months
  description: Changes in the Perceived Stress Scale (PSS) score at 3 months after the SMS setting up the wellness pathway. The PSS is a score based on the sum of the values assigned to each response of 10 different items. The minimum score is 0 and the maximum score is 50. The higher the score, the more stressed the respondent is.
  measure: Evaluate the effectiveness of a well-being programme in improving stress management in healthcare professionals and workers with moderate stress at 6 months
  time frame: 6 Months
  description: Change in the Perceived Stress Scale (PSS) at 6 months from the SMS used to set up the wellness pathway. The PSS is a score based on the sum of the values assigned to each response of 10 different items. The minimum score is 0 and the maximum score is 50. The higher the score, the more stressed the respondent is.
  measure: Evaluate the effectiveness of a well-being programme in improving the lifestyle habits of healthcare professionals and workers at 3 and 6 months
  time frame: 3 and 6 Months
  description: Evolution of the score obtained in the Lifestyle Questionnaire at 3 and 6 months after the SMS for the implementation of the wellness pathway. The Lifestyle Questionnaireis a score based on the assignment of a score for 4 health risk domains: Stress, Diet, Physical Activity and Sleep. The minimum score is 0 and the maximum score is 100 for each of the 4 items. The lower the score, the more the respondent to the questionnaire has a risk profile.
  measure: Compare the effectiveness of a well-being programme in improving stress management among healthcare professionals and workers, depending on their job
  time frame: 3 and 6 Months
  description: Changes in the Perceived Stress Scale (PSS) according to the professions of the healthcare professionals. The PSS is a score based on the sum of the values assigned to each response of 10 different items. The minimum score is 0 and the maximum score is 50. The higher the score, the more stressed the respondent is.
  measure: Observe the acceptability to healthcare professionals and workers of setting up a well-being programme
  time frame: 3 and 6 Months
  description: The participation rate of the participants will be collected through a series of closed questions with multiple choice answers on the type of course taken and the dates of the follow-ups. The satisfaction rate of the participants' well-being journey will be collected through a closed question with a dichotomous answer of the Yes / No type.
  intervention type: Behavioral
  intervention name: Wellness trail
  description: Setting up wellness trails based on four distinct themes:
  Food, Nutrition and Micronutrition
  Physical activity
  Sleep
  Stress and well-being
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Eric MYON
  role: Principal Investigator
  affiliation: CPTS Paris 8
  last name: Eric MYON, Doctor
  phone: 01.48.74.74.91
  email: eric_myon@yahoo.fr
  last name: Myriam HASSANI
  phone: 07.88.67.41.68
  email: cpts.paris8@gmail.com
  facility: 
  country: France
  responsible party type: Sponsor
  mesh term: Occupational Stress
  sharing ipd: No