AzTrials
AzTrials

EmpowermentCHRYSALIDENCT04010773

Impact at Two Years of an Intervention Program on the Empowerment of Medical and Nursing Teams in a French Hospital

An observational study of Empowerment, run by Nantes University Hospital at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Health in France asks public hospitals to promote quality of working life (QWL), seen as a performance factor. Consistently with empowerment literature, they define QWL as giving workers mastery over their working life. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Empowerment
What is being tested?
collective and psycho-social intervention
How many people
1,191 participants
Where
1 siteFrance
Study dates
16 Jan 2018to 30 Aug 2021
How long will I take part?
2 Years
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
  • No healthy volunteers
  • Adult, Older adult

Study population: all professionals working in the care services of the experimental and control UPHs.

Who may be able to join

  • Working in one of the care units of the SC that has been randomly selected to benefit from the intervention.

Who cannot join

  • Criteria for not including UHPs
  • Capacity-building or major reorganization planned during the study period. Criteria for not including services
  • Chiefdom of the service opposed to the intervention.
  • Strike movement in the team during the inclusion phase. Criteria for not including professionals
  • Refusal to participate in the study.
  • Physical or psychological condition that prevents the completion of questionnaires.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Nantes University Hospital

    Nantes, 44093

Other trials in France

About this study

Official title: Project for the Liberation of Organizations in an University Hospital in France: A Randomized Controlled Study of the Impact at Two Years of an Intervention Program on the Empowerment of the Medical and Nursing Teams

Health in France asks public hospitals to promote quality of working life (QWL), seen as a performance factor. Consistently with empowerment literature, they define QWL as giving workers mastery over their working life. The problem is, French hospitals follow a bureaucratic model, defined by a managerial culture of control and a stratified organization, which weakens mastery of their work, and hinders their commitment and performance. Main objective of CHRYSALIDE, is to create a managerial and organizational transition program of 1 year, and to test its effect at two years on workers empowerment in an university hospital Sub-Center (SC), in comparison with another SC from the same University Hospital Center (CHU) in a randomized controlled study design.

Read the detailed description

The main objective of CHRYSALIDE is to implement an easy-to-replicate intervention program of 1 year, in order to promote empowering behaviors in directors and front line supervisors in SC, and to test its impact at two years on workers scores of structural empowerment, in comparison with another SC from the same University Hospital Center (CHU).

The secondary objective is to assess the effect of the intervention on psychological empowerment.

To answer to the main objective, quantitative data will be collected three times during the project: Before the implementation, directly after the intervention, and 1 year after the end of the intervention, or 2 years after the beginning. To improve our understanding of what happened during the intervention, a systematic ethnographic report will be done by the investigators and the facilitators engaged in the intervention.

Quantitative data collection will occur during the occupational health visit that is required to be done every two years considering French legislation. For the need of the study, visits will be done every years, and scheduled to match with the beginning and the end of the intervention.

Quantitative data consist in (1) self-reported questionnaires, (2) standardized assessment by medical practitioner during the visit, (3) institutional indicators routinely collected by the SC.

Conditions
Empowerment
Being tested
collective and psycho-social intervention
Keywords
Empowerment, leadership, intervention, psycho-social intervention, motivation, working conditions, occupational health
Medical subject headings
Empowerment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • collective and psycho-social interventionOther

    The intervention duration is 1 year. It combine (1) In each unit, working groups aimed at improving QWL, (2) counseling and training of directors and frontline managers, and (3) in each unit, concertation meeting between workers, front-line managers and directors.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Structural empowerment, assessed with the Conditions for Work Effectiveness Questionnaire II (CWEQII).

    This self-reported questionnaire is composed of 19 items about how the worker perceives his work environment. They allow calculation of 6 sub-scores and 1 global score of structural empowerment, reflecting access to the aspects of work environment known to mediate the control of workers over their job. The subscores are "formal power", "informal power", "opportunity", "information", "support" and "resources". They are calculated by summing their specific items, and dividing by 3, except for "informal power" for which the sum is divided by 4. Every sub-score is between 1 and 5. The global score of structural empowerment is calculated by summing the 6 sub-scores. The global score is between 5 and 30. There is not any threshold for the sub-scores and the global score: the higher the scores, the more empowering the working conditions are. The global score is the primary outcome in this study. Safety issue : No.

    Measured: 12 months and 24 months after initial measure.

Secondary outcomes (1)

  1. Psychological empowerment, assessed with the Psychological Empowerment Scale (PES).

    This self-reported questionnaire is composed of 12 items. They allow calculation of 4 sub-scores and 1 global score of psychological empowerment, reflecting cognitions-believes people with power have about themselves. The sub-scores are "autonomy", "impact", "competence" and "meaning". The sub-scores are calculated by summing their specific items. They are between 15 and 25. The global score is calculated by summing the sub-scores and dividing by 4. It is between 15 and 25. There is not any threshold for the global and sub-scores: the higher the scores, the more people are psychologically empowered. The global score of psychological empowerment is considered as a secondary outcome in this study.

    Safety Issue: No

    Measured: 12 months and 24 months after initial measure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2019
  2. Study start16 Jan 2018
  3. Primary completion30 Oct 2020
  4. Study completion30 Aug 2021

Resources

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
Other
Time perspective
Prospective
Enrolment
1,191 participants (actual)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04010773
Sponsor's protocol ID
RC17_0014
Acronym
CHRYSALIDE
Status last verified
Jun 2019
First submitted
27 Jun 2019
Last updated
13 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Cougot B, Gillet N, Moret L, Gauvin J, Caillet P, Fleury-Bahi G, Lesot J, Ollierou F, Armant A, Peltier A, Fouquereau E, Getz I, Bach-Ngohou K, Tripodi D. Relationship between Empowering Leadership and Stress in a French University Hospital: A Cross-Sectional Study Combining the Measurement of Perceived Stress and Salivary Cortisol. J Nurs Manag. 2024 Jan 31;2024:8839893. doi: 10.1155/2024/8839893. eCollection 2024.

    PubMed 40224754

  • Cougot B, Gillet N, Morin AJS, Gauvin J, Ollierou F, Moret L, Tripodi D. A longitudinal investigation of structural empowerment profiles among healthcare employees. J Nurs Scholarsh. 2024 May;56(3):417-429. doi: 10.1111/jnu.12950. Epub 2023 Dec 13.

    PubMed 38093467

  • Cougot B, Gillet N, Gauvin J, Caillet P, Fleury-Bahi G, Ollierou F, Armant A, Peltier A, Getz I, Bach-Ngohou K, Tripodi D, Moret L. Impact of empowering leadership on emotional exhaustion: A controlled interventional study in a large French university hospital complex. J Nurs Manag. 2022 Nov;30(8):4234-4250. doi: 10.1111/jonm.13829. Epub 2022 Oct 17.

    PubMed 36190480

  • Cougot B, Gauvin J, Gillet N, Bach-Ngohou K, Lesot J, Getz I, Deparis X, Longuenesse C, Armant A, Bataille E, Leclere B, Fleury-Bahi G, Moret L, Tripodi D. Impact at two years of an intervention on empowerment among medical care teams: study protocol of a randomised controlled trial in a large French university hospital. BMC Health Serv Res. 2019 Dec 3;19(1):927. doi: 10.1186/s12913-019-4724-7.

    PubMed 31796029

Questions about this trial

What is this clinical trial studying?

An observational study of Empowerment, run by Nantes University Hospital 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 1 inclusion and 6 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 13 Sep 2021. 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?

Structural empowerment, assessed with the Conditions for Work Effectiveness Questionnaire II (CWEQII). (time frame: 12 months and 24 months after initial measure.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04010773, which also lists 4 linked publications.

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 13 Sep 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in