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Not yet recruiting NCT07504042

Resilience Toolbox Intervention in Elderly Care

No phase Interventional Mental Wellbeing of Older Adults

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Support4Resilience toolbox.
Who it may be relevant to
Registry conditions: Mental Wellbeing of Older Adults. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effectiveness of a Leader-Led Resilience Toolbox Intervention on Mental Wellbeing, Burnout, and Turnover Intention in Elderly Care Workers: A Cluster Randomized Controlled Trial With Repeated Measures

Overview

The goal of this cluster randomized controlled trial is to test if the Support4Resilience toolbox can improve mental wellbeing of healthcare workers in elderly care. The main questions it aims to answer is: Is the Support4Resilience toolbox effective in improving the mental wellbeing of healthcare workers in elderly care? Researchers will compare an intervention and a control group to see if the use of the Support4Resilience toolbox improves the mental wellbeing of the intervention arm participants. Participants will be given access to the toolbox and structured workshops will be organized for them to use it. Participants in the control arm will not have access to the toolbox and no other alternative activities are planned.

Detailed description

This study is a cluster randomized controlled trial conducted within the Support4Resilience (S4R) project, aiming to evaluate the effectiveness of a structured resilience intervention ("toolbox") in improving mental wellbeing among healthcare workers in elderly care settings.

The study is conducted in two countries, Norway and Finland, and includes a total of 30 clusters (15 per country). Clusters are defined as organizational units within elderly care settings (each municipality has 1 or more units), within which leaders and healthcare workers participate jointly in the intervention. The average cluster size is approximately 30 healthcare workers.

The intervention is designed as a leader-supported, practice-oriented program consisting of a series of structured workshops in which leaders and healthcare workers collaboratively engage with and implement tools targeting mental wellbeing organizational resilience. The toolbox includes strategies to enhance coping, communication, reflection, and supportive work practices. The intervention is implemented at the cluster level, reflecting its organizational focus and minimizing contamination between participants.

Clusters are randomized to either the intervention group or a control group. Clusters allocated to the intervention group receive access to the Support4Resilience toolbox and participate in a sequence of five main workshops, followed by a final workshop focused on reflection and discussion of results. The intervention is delivered over a period of approximately 12 months. The timing of workshops is adapted to local organizational needs, but they are generally conducted at intervals of approximately 2-3 months. Between workshops, participants are encouraged to apply and integrate the toolbox components into daily practice. Clusters in the control group continue with usual practice and do not receive access to the toolbox during the study period.

Data are collected at six time points: one baseline assessment prior to the start of the intervention and five follow-up assessments conducted after each of the main workshops. This repeated-measures design allows for the evaluation of both overall intervention effects and changes over time.

The primary outcome is mental wellbeing, measured using the Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS). Secondary outcomes include burnout, assessed using the Maslach Burnout Inventory (MBI), and intention to leave the job, measured using the Michigan Organizational Assessment Questionnaire (MOAQ). All outcomes are collected through self-administered questionnaires. Based on expected participation patterns, a response rate of at least 30% across all six measurement points is anticipated.

Due to the nature of the intervention, participants and implementers cannot be blinded to group allocation. However, outcome assessment is standardized across groups and time points using validated instruments, and statistical analyses will be conducted according to a predefined analysis plan.

Assuming an intra-cluster correlation coefficient of 0.05, this design is expected to provide adequate power to detect a moderate intervention effect on the primary outcome, while accounting for clustering. The repeated-measures design and use of mixed-effects models are expected to further improve efficiency by incorporating all available observations over time.

The findings of this study are expected to provide robust evidence on the effectiveness of organizational and leadership-supported interventions to promote mental wellbeing and resilience among healthcare workers in elderly care, and to inform future implementation and scale-up across different healthcare systems.

Interventions

  • Behavioral Support4Resilience toolbox
    The Support4Resilience toolbox includes 3 tools that elderly care leaders will use in collaboration with their workers. The tools are the following: 1. Mapping and identification tool: it provides leaders with a holistic awareness of the current status of the organization through integrating healthcare workers' and informal caregivers' perspectives. 2. Reflection and education tool: it provides contextual understanding of 'work-as-done' rather than 'work-as-imagined', and educational components

Primary outcome measures

  • Mental wellbeing [Time frame: From enrollment to the end of treatment at 12 months]
Secondary outcome measures (2)
  • Work-related burnout [Time frame: From enrollment to the end of treatment at 12 months]
  • Turnover intentions [Time frame: From enrollment to the end of treatment at 12 months]

Eligibility criteria

Inclusion criteria

  • Healthcare workers and leaders in elderly care settings
  • Employed in participating organizations in Norway and Finland
  • Able to provide informed consent

Exclusion criteria

  • Not actively working during the intervention period
  • Inability to complete questionnaires

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Lyng HB, Haraldseid-Driftland C, Lungu DA, Viksveen P, Akerjordet K, Glette MK, Ree E, Guise V, Haver A, Bergerod IJ, Kankaanpaa E, Kapitsaki GM, Chatzittofis A, Ellis LA, Bal R, Tibu F, Delgado-Saborit JM, Tolosa A, Cantarelli P, Vola F, Lahti M, Parmentier H, Raknes Sogstad MK, Engel C, Vincent C, Braithwaite J, Pfaff H, Wiig S. Strengthening Resilience and Mental Well-Being Through the Support4 PMID 42475674

Identifiers

NCT: NCT07504042 · S4R-WP4-cRCT · 101136291

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗