Strengthening resilience and mental wellbeing through the Support4Resilience toolbox for leaders in elderly care

ISRCTN ISRCTN23120085
DOI https://doi.org/10.1186/ISRCTN23120085
Secondary identifying numbers Project 101136291
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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

Study website

Contact information

Prof Siri Wiig
Public, Scientific, Principal Investigator

Universitetet i Stavanger
Postboks 8600
Stavanger
4036
Norway

ORCiD logoORCID ID 0000-0003-0186-038X
Phone +47 51834288
Email siri.wiig@uis.no

Study information

Study designMulticenter cluster randomized controlled trial, including 30 clusters each with healthcare workers within homecare services in two countries (Finland and Norway)
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)Home
Study typeQuality of life, Safety, Efficacy
Participant information sheet Not available in web format, please use the contact details to request a participant information sheet
Scientific titleStrengthening resilience and mental wellbeing through the Support4Resilience toolbox for leaders in elderly care
Study acronymSupport4Resilience
Study objectivesThe 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 informationThe 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) studiedMental wellbeing
InterventionThe 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 typeOther
Primary outcome measureMental wellbeing measured using the Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) at 12 months
Secondary outcome measuresThe following secondary outcome measures are assessed at 12 months:
1. Resilience at an individual level, measured using the Connor-Davidson Resilience Scale (CD-RISC)
2. Resilience at a systems level, measured using the Resilience Capacity Scale (RCS)
3. Burnout measured using the Copenhagen Burnout Inventory (CPI)
4. Intention to leave their job measured using the Michigan Organizational Assessment Questionnaire (MOAQ)
5. Subjective measure of a person's health measured using the Self-Assessed Health (SAH)
Overall study start date01/03/2024
Completion date31/08/2027

Eligibility

Participant type(s)Health professional
Age groupMixed
Lower age limit18 Years
Upper age limit75 Years
SexBoth
Target number of participants900
Key inclusion criteriaHealthcare professional working in homecare services
Key exclusion criteriaNot meeting the participant inclusion criteria
Date of first enrolment01/01/2026
Date of final enrolment31/03/2026

Locations

Countries of recruitment

  • Finland
  • Norway

Study participating centres

SHARE Centre for Resilience in Healthcare, Faculty of Health Sciences, University of Stavanger
Postboks 8600 Forus
Stavanger
4036
Norway
NTNU Gjøvik
Postboks 191
Gjøvik
2802
Norway
Turku University of Applied Sciences
ICT-City, Joukahaisenkatu 3
Turku
20520
Finland

Sponsor information

University of Stavanger
University/education

Postboks 8600 Forus
Stavanger
4036
Norway

Phone +47 99274615
Email eldar.soreide@uis.no
Website https://www.uis.no/en/faculty-of-health-sciences
ROR logo "ROR" https://ror.org/02qte9q33

Funders

Funder type

Government

European Health and Digital Executive Agency
Government organisation / National government
Alternative name(s)
Health and Digital Executive Agency, HaDEA

Results and Publications

Intention to publish date28/02/2028
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryStored in publicly available repository
Publication and dissemination planThe publication and dissemination plan includes tailormade dissemination, communication, and exploitation of project results (DEC) to different stakeholders in Europe, including leaders as future users of the S4R Toolbox, policy makers, informal caregivers, healthcare workers, the scientific community, and the public. The plan will entail approaches to achieve DEC results including scientific publications, conference attendance, social media, podcast, webinars, public debates, and policy briefs. The project will ensure continuous scientific open access publications in international peer review journals throughout the project period, including high impact peer review journals (e.g., Lancet, BMJ Quality and Safety, Social Science and Medicine). Open science practice will be integral throughout the entire project. All scientific publications will be open access using agreements with publishers where available. Information will also be spread through social media (e.g. LinkedIn and Twitter/X), newsletters, newspaper chronicles, scientific conferences, and the project website.
IPD sharing planSupport4Resilience 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.

Editorial Notes

11/11/2024: Study's existence confirmed by the European Health and Digital Executive Agency
(HADEA).