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Occupational Healthe-ResilienciaNCT06724770

Design of an Intervention to Equip Middle Managers and Managers in Healthcare Institutions With Tools to Increase the Resilience of Their Teams

A study testing Resilience training intervention in people with Occupational Health and Resilience, run by Irene Carrillo Murcia at 1 site in Spain.

Completed

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

Official record
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Trial summary

The main objective of this preparatory action (experimental study without control group, before and after measurements) is to develop and test the feasibility of the e-Resilience tool in a relevant environment (TRL6). Read more about this study

Who is it for?
Ages 26 to 65 years
Conditions the study is for
Occupational Health, Resilience, Job Stress
What is being tested?
Resilience training intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSpain
Study dates
15 Jan 2024to 26 Nov 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 26 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Healthcare professionals and middle management in active healthcare institutions.

Who cannot join

  • Inability to complete the web-based intervention due to access difficulties or lack of digital literacy.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Universidad Miguel Hernández de Elche

    Elche, Alicante, 03202

Other trials in Spain

About this study

Official title: Diseño de Una intervención Para Dotar a Mandos Intermedios y Directivos de Instituciones Sanitarias Con Herramientas Para Incrementar la Resiliencia de Sus Equipos

The main objective of this preparatory action (experimental study without control group, before and after measurements) is to develop and test the feasibility of the e-Resilience tool in a relevant environment (TRL6). This web-based tool has been designed to facilitate the work of the top and middle management of healthcare institutions to strengthen the resilience of their teams to face critical situations inherent to healthcare activity.

The main questions it aims to answer are:

Read more
  1. Which components of the e-Resilience intervention need to be improved?
  2. Does the e-Resilience tool improve the knowledge of middle managers in healthcare institutions on specific techniques and strategies to strengthen the resilience of the professionals and teams under their care?
  3. Is the e-Resilience tool helpful and applicable to clinical settings in the opinion of middle managers in healthcare institutions?

Participants in the study are middle management and healthcare professionals from primary care centres and hospitals in the Valencian Community (Spain). A group of experts review the components of the intervention/tool to improve its adaptability to clinical settings. Subsequently, a sample of healthcare professionals and middle managers complete the intervention by answering a knowledge questionnaire before and after the intervention and a survey to evaluate the tool.

There is no control group.

Being tested
Resilience training intervention
Medical subject headings
Occupational Stress

What participants receive

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

  • Resilience training interventionOther

    Training intervention on tools and strategies to strengthen the resilience of work teams in healthcare centres.

Study groups in NCT06724770
Study groupRoleWhat they receive
e-Resilience InterventionExperimentalMiddle management and healthcare professionals who voluntarily participate in the e-Resilience intervention.
Receives: Other: Resilience training intervention

What is being measured

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

  1. Number of incorporations and adaptations necessary for the validation of e-Resilience in a relevant environment.

    Number of change proposals of the expert group to adapt the tool to the target environments' needs and enhance its applicability.

    Measured: 5 months

  2. Hits on resilience knowledge questionnaire (pre-intervention).

    Number of correct answers to questions on knowledge of models, techniques, tools and strategies for building resilience in clinical settings.

    Measured: 3 months

  3. Hits on resilience knowledge questionnaire (post-intervention).

    Number of correct answers to questions on knowledge of models, techniques, tools and strategies for building resilience in clinical settings.

    Measured: 3 months

Secondary outcomes (6)

  1. Clarity of the e-Resilience tool components.

    Clarity of the e-Resilience tool components (scale 1-5, where 1 = not clear at all and 5 = totally clear).

    Measured: 3 months

  2. Usefulness and applicability of the e-Resilience tool.

    Usefulness and applicability of the e-Resilience tool (scale 1-5, where 1 = not useful or applicable at all and 5 = fully useful and applicable).

    Measured: 3 months

  3. Perception of improvement of own capacity to strengthen the resilience of healthcare teams.

    The contents of the course have allowed me to learn strategies to strengthen the resilience of the professionals or teams in my charge (scale 1-5, where 1 = strongly disagree and 5 = strongly agree).

    Measured: 3 months

  4. Willingness to recommend e-Resilience.

    I will recommend the intervention to other colleagues (scale 1-5, where 1 = strongly disagree and 5 = strongly agree).

    Measured: 3 months

  5. Willingness to use e-Resilience in the future.

    I will apply any of the tools or strategies learned to strengthen individual, team or organisational resilience in my work environment. (scale 1-5, where 1 = strongly disagree and 5 = strongly agree).

    Measured: 3 months

  6. Overall satisfaction with the e-Resilience intervention.

    Overall satisfaction with the e-Resilience intervention (scale 0-10, where 0 = not at all satisfied and 10 = completely satisfied).

    Measured: 3 months

Timeline

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

  1. First posted9 Dec 2024
  2. Study start15 Jan 2024
  3. Primary completion26 Nov 2024
  4. Study completion26 Nov 2024

Resources

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
Model description
Participants voluntarily adhere to the intervention. The intervention consists of the review and use of the e-Resilience tool. It is a toolkit that provides training in skills to strengthen the resilience of teams working in healthcare institutions. Participants complete knowledge questionnaires before and after the intervention. There is no control group.
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06724770
Sponsor's protocol ID
ILISABIO22_AP09
Acronym
e-Resiliencia
Status last verified
Dec 2024
First submitted
29 Nov 2024
Last updated
9 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Seys D, Panella M, Russotto S, Strametz R, Joaquin Mira J, Van Wilder A, Godderis L, Vanhaecht K. In search of an international multidimensional action plan for second victim support: a narrative review. BMC Health Serv Res. 2023 Jul 31;23(1):816. doi: 10.1186/s12913-023-09637-8.

    PubMed 37525127

  • Mira JJ, Vicente MA, Lopez-Pineda A, Carrillo I, Guilabert M, Fernandez C, Perez-Jover V, Martin Delgado J, Perez-Perez P, Cobos Vargas A, Astier-Pena MP, Martinez-Garcia OB, Marco-Gomez B, Abad Bouzan C. Preventing and Addressing the Stress Reactions of Health Care Workers Caring for Patients With COVID-19: Development of a Digital Platform (Be + Against COVID). JMIR Mhealth Uhealth. 2020 Oct 5;8(10):e21692. doi: 10.2196/21692.

    PubMed 32936769

  • Venegas CL, Nkangu MN, Duffy MC, Fergusson DA, Spilg EG. Interventions to improve resilience in physicians who have completed training: A systematic review. PLoS One. 2019 Jan 17;14(1):e0210512. doi: 10.1371/journal.pone.0210512. eCollection 2019.

    PubMed 30653550

  • Stoliker BE, Vaughan AD, Collins J, Black M, Anderson GS. Building Personal Resilience following an Online Resilience Training Program for BScN Students. West J Nurs Res. 2022 Aug;44(8):755-764. doi: 10.1177/01939459211017240. Epub 2021 May 17.

    PubMed 33998338

  • Strametz R, Raspe M, Ettl B, Huf W, Pitz A. [Recommended actions: Reinforcing clinicians' resilience and supporting second victims during the COVID-19 pandemic to maintain capacity in the healthcare system]. Zentralbl Arbeitsmed Arbeitsschutz Ergon. 2020;70(6):264-268. doi: 10.1007/s40664-020-00405-7. Epub 2020 Sep 2. German.

    PubMed 32905028

  • Raetze S, Duchek S, Maynard MT, Wohlgemuth M. Resilience in organization-related research: An integrative conceptual review across disciplines and levels of analysis. J Appl Psychol. 2022 Jun;107(6):867-897. doi: 10.1037/apl0000952. Epub 2021 Nov 11.

    PubMed 34766796

  • Daly LM. Resilience: An Integrated Review. Nurs Sci Q. 2020 Oct;33(4):330-338. doi: 10.1177/0894318420943141.

    PubMed 32940160

  • Winwood PC, Colon R, McEwen K. A practical measure of workplace resilience: developing the resilience at work scale. J Occup Environ Med. 2013 Oct;55(10):1205-12. doi: 10.1097/JOM.0b013e3182a2a60a.

    PubMed 24064782

  • Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194-200. doi: 10.1080/10705500802222972.

    PubMed 18696313

  • Wagnild GM, Young HM. Development and psychometric evaluation of the Resilience Scale. J Nurs Meas. 1993 Winter;1(2):165-78.

    PubMed 7850498

  • Bartone PT, Ursano RJ, Wright KM, Ingraham LH. The impact of a military air disaster on the health of assistance workers. A prospective study. J Nerv Ment Dis. 1989 Jun;177(6):317-28. doi: 10.1097/00005053-198906000-00001.

    PubMed 2723619

  • Wiig S, Aase K, Billett S, Canfield C, Roise O, Nja O, Guise V, Haraldseid-Driftland C, Ree E, Anderson JE, Macrae C; RiH-team. Defining the boundaries and operational concepts of resilience in the resilience in healthcare research program. BMC Health Serv Res. 2020 Apr 19;20(1):330. doi: 10.1186/s12913-020-05224-3.

    PubMed 32306981

  • Sisto A, Vicinanza F, Campanozzi LL, Ricci G, Tartaglini D, Tambone V. Towards a Transversal Definition of Psychological Resilience: A Literature Review. Medicina (Kaunas). 2019 Nov 16;55(11):745. doi: 10.3390/medicina55110745.

    PubMed 31744109

  • Bodenheimer T, Sinsky C. From triple to quadruple aim: care of the patient requires care of the provider. Ann Fam Med. 2014 Nov-Dec;12(6):573-6. doi: 10.1370/afm.1713.

    PubMed 25384822

  • Schwappach DL, Boluarte TA. The emotional impact of medical error involvement on physicians: a call for leadership and organisational accountability. Swiss Med Wkly. 2009 Jan 10;139(1-2):9-15. doi: 10.4414/smw.2009.12417.

    PubMed 18951201

Questions about this trial

What is this clinical trial studying?

A study testing Resilience training intervention in people with Occupational Health and Resilience, run by Irene Carrillo Murcia at 1 site in Spain.

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 1 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 9 Dec 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 Spain. 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?

Number of incorporations and adaptations necessary for the validation of e-Resilience in a relevant environment. (time frame: 5 months). The study lists 3 primary outcomes in all. 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 NCT06724770, which also lists 19 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 9 Dec 2024.

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