Strengthening resilience and mental wellbeing through the Support4Resilience toolbox for leaders in elderly care
| ISRCTN | ISRCTN23120085 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23120085 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Project 101136291 |
| Sponsor | University of Stavanger |
| Funder | European Health and Digital Executive Agency |
- Submission date
- 08/11/2024
- Registration date
- 17/01/2025
- Last edited
- 17/01/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
European elderly care experiences labor shortages, a lack of qualified workers and a mismatch between capacity and demands, causing stress, burnout, and reduced mental wellbeing among healthcare workers and informal caregivers. Leaders are crucial in promoting supportive working conditions but lack research-based measures to address these challenges. Support4Resilience (S4R) will develop, implement, and evaluate a research-based Toolbox to support healthcare leaders in improving healthcare workers’ and informal caregivers’ resilience and mental wellbeing in elderly care. S4R will identify resilience and mental wellbeing factors among healthcare workers and informal caregivers; explore their perspectives and needs; develop a new theory on the relationship between individual and organizational resilience, and mental wellbeing; and develop recommendations and cost-effective interventions. The Toolbox with tailormade resources for policy and practical use will be available through an open-access S4R Resource Bank. The S4R Toolbox includes three main tools: 1) Mapping and identification, 2) Reflection and education, and 3) Reorganization. Measures are initiated at the organizational level and effects on mental wellbeing and resilience transpire at the frontline of elderly care. The Toolbox covers different situational contexts, types of healthcare providers and health system levels. Elderly care settings in six European countries and Australia will implement and evaluate the Toolbox through a process evaluation, effectiveness evaluation, and cost-effectiveness evaluation. S4R provides policymakers, decision-makers and leaders with solutions for taking action to solve specific risks for healthcare workers' and informal caregivers' resilience and mental wellbeing. Thus, S4R will support the development of resilient health systems in elderly care through improved leadership capabilities, governance structures, and adaptive capacities.
Who can participate?
Healthcare workers aged between 18 and 75 years old in homecare services
What does the study involve?
Participants in intervention group clusters receive support from their leaders using the Support4Resilience toolbox for leaders in elderly care. Participants in the control group receive support from their leaders as usual ("treatment as usual group").
What are the possible benefits and risks of participating?
The possible benefits of participating include additional support and training for leaders, which may have a positive effect on participants’ resilience and mental wellbeing. There is no expected risk or burden of participating on than the time participants spend completing questionnaires.
Where is the study run from?
SHARE Centre for Resilience in Healthcare, Faculty of Health Sciences, University of Stavanger, Norway
When is the study starting and how long is it expected to run for?
March 2024 to August 2027
Who is funding the study?
European Health and Digital Executive Agency, European Commission
Who is the main contact?
Prof Siri Wiig, siri.wiig@uis.no
Contact information
Public, Scientific, Principal investigator
Universitetet i Stavanger
Postboks 8600
Stavanger
4036
Norway
 ORCID ID |
0000-0003-0186-038X |
|---|---|
| Phone | +47 51834288 |
| siri.wiig@uis.no |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicenter cluster randomized controlled trial, including 30 clusters each with healthcare workers within homecare services in two countries (Finland and Norway) |
| Secondary study design | Cluster randomised trial |
| Study type | Participant information sheet |
| Scientific title | Strengthening resilience and mental wellbeing through the Support4Resilience toolbox for leaders in elderly care |
| Study acronym | Support4Resilience |
| Study objectives | The Support4Resilience Toolbox can support leaders in elderly care to improve mental wellbeing in healthcare workers. |
| Ethics approval(s) |
Approved 27/09/2024, The Research Ethics Committee of Turku UAS (FI-20014 Turun yliopisto, Turun yliopisto, FI-20014, Finland; +358 40 3350 526; tutkimusetiikka@turkuamk.fi), ref: 14/2024 |
| Ethics approval additional information | The Norwegian Regional Committees for Medical and Health Research Ethics (REK) determined that the project did not need ethics approval in Norway (reference 777006). The project was however assessed by the Norwegian Agency for Shared Services in Education and Research, which concluded that the project complies with the General Data Protection Regulation (GDPR) and the Norwegian Personal Data Act (reference 881988). |
| Health condition(s) or problem(s) studied | Mental wellbeing |
| Intervention | The intervention used in the treatment arm is a Support4Resilience toolbox for leaders in elderly care. However, it is not possible at this stage to provide a complete description of the intervention, as it will be developed in the first stages of the project using input received from the different end users, including leaders, healthcare professionals and informal caregivers. Participants in the control group will receive support from their leaders as usual ("treatment as usual group"). |
| Intervention type | Other |
| Primary outcome measure(s) |
Mental wellbeing measured using the Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) at 12 months |
| Key secondary outcome measure(s) |
The following secondary outcome measures are assessed at 12 months: |
| Completion date | 31/08/2027 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | All |
| Target sample size at registration | 900 |
| Key inclusion criteria | Healthcare professional working in homecare services |
| Key exclusion criteria | Not meeting the participant inclusion criteria |
| Date of first enrolment | 01/01/2026 |
| Date of final enrolment | 31/03/2026 |
Locations
Countries of recruitment
- Finland
- Norway
Study participating centres
Stavanger
4036
Norway
Gjøvik
2802
Norway
Turku
20520
Finland
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in publicly available repository |
| IPD sharing plan | Support4Resilience will use appropriate metadata to assist in finding the relevant data. Data will be stored in a shareable data storage (a link will be provided as soon as established). Existing open-access repositories will be used, and appropriate digital object identifiers (DOI) will be provided, e.g., EU Open Data Portal Zenodo, figshare for data, arXiv for research publications. A dedicated glossary will be created to label datasets. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
11/11/2024: Study's existence confirmed by the European Health and Digital Executive Agency
(HADEA).
