An interventional study of Solution Prototype in Germany and Solution Prototype in Italy in Mental Wellbeing, sponsored by VU University of Amsterdam. Not yet recruiting at 5 sites in 5 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by VU University of Amsterdam · Not applicable, Interventional, and Health services research
WELL CARE aims to strengthen the supports available to informal carers and long-term care (LTC) workers for improving their resilience and mental wellbeing through care partnerships. The project consortium, lead by prof. Elizabeth Hanson (Linnaeus University) and consisting of six research organizations and nine national and European advocacy organizations, identifies good practices able to prevent or mitigate both occupational and non-occupational risks for informal carers' and LTC workers' resilience and mental wellbeing. On this basis, and under its Grant Agreement with the European Commission, the project team develops innovative solution prototypes, which will be transferable across different countries and contexts and guide stakeholders into the actual implementation in 5 European Union (EU) countries (Germany, Italy, Netherlands, Slovenia, Sweden), where the LTC sector presents dissimilar characteristics. Finally, the investigators will exploit the data and evidence collected and generated by WELL CARE to analyze related EU and national policies, and to formulate action-oriented recommendations for policy makers and stakeholders.
The current study protocol concerns the research activities within Work Package 3 of the project, particularly the activities during the Implementation and Evaluation Phase that runs from September 2026 until the end of 2027. During this phase the project team studies the results of local implementation partners' efforts who - building on the solution prototypes developed earlier in the WELL CARE project - develop and implement new supportive work and care practices. The investigators study the effects that implementing these practices brings about among participating caregivers in terms of mental wellbeing, resilience and care partnership dynamics, while also studying the implementation process itself to capture the processes, conditions and (organizational) contexts favorable to fostering care partnerships.
VU University of Amsterdam is the lead sponsor of 48 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria for recruiting participants will be...
For informal caregivers:
o currently providing - or having provided within the last 6 months - unpaid care or support to a family member, partner, or friend receiving long-term care services;
For long-term care workers:
For care recipients:
living in the community or in a long-term care setting included in the study;
- for other stakeholders:
For all participants:
The exclusion criteria for recruiting participants will be...
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
adults (≥18 years), providing- usually- unpaid care to someone (relatives or friends) with a chronic illness, disability and/or other long lasting health and/or care need, outside a professional or formal framework
Other: Solution Prototype in Germany · Other: Solution Prototype in Italy · Other: Solution Prototype in Slovenia · Other: Solution Prototype in Sweden · Other: Solution Prototype in the Netherlands
adults (≥18 years), working in home and/or residential care settings with people with LTC needs
Other: Solution Prototype in Italy · Other: Solution Prototype in Slovenia · Other: Solution Prototype in Sweden · Other: Solution Prototype in the Netherlands
will be included in the study if their participation is not unduly burdensome. Care recipients in this study are individuals who require support with everyday personal care and/or more complex daily tasks due to ageing, chronic illness, disability or frailty. These needs are increasingly complex, frequently involving multimorbidity and requiring coordinated input from both formal long-term care services and informal carers. The characteristics and needs of care recipients are closely linked to caregiver burden, wellbeing and care intensity, and are therefore an important contextual factor in this study. Moreover, care partnerships dynamics may improve the quality of care that care recipients experience.
Other: Solution Prototype in Italy · Other: Solution Prototype in Slovenia · Other: Solution Prototype in Sweden · Other: Solution Prototype in the Netherlands
The characteristics of other stakeholders included in the study may differ per research site, depending on the characteristics of the implemented practices and the context in which implementation is done. This group of respondents will include managers, planners, policy makers, organizational officials or care professionals who are not engaged in the caregiving process itself, but whose work is directly affected by the implemented practices at the research site, and/or whose work may either promote or hamper successful and sustainable implementation.
Other: Solution Prototype in Germany · Other: Solution Prototype in Italy · Other: Solution Prototype in Slovenia · Other: Solution Prototype in Sweden · Other: Solution Prototype in the Netherlands
Project partners are developing a digital educational program for informal carers, covering different phases of caregiving. In addition, a peer-to-peer support program will be developed following a train-the-trainer format. Activities also focus on securing structural funding and enabling broader rollout across the country.
Project partners are collaborating with a large long-term care provider to develop a process for the co-creation of care plans with informal carers. In addition, a mindfulness-based stress reduction intervention is being developed in which informal carers and long-term care workers can participate jointly. These activities aim to improve communication and foster trusting relationships between these groups.
Project partners will work with the management of formal care institutions to provide leadership training focused on supporting informal carers' well-being and strengthening collaboration with them. In addition, workshops will be organized to enhance carers' skills, knowledge and self-care practices, alongside joint events to promote mutual understanding and collaboration between formal and informal carers. Community-level activities will also be implemented to increase recognition of carers and the value of care.
Project partners are working across three sites with distinct areas of focus: (1) within respite care homes, fostering mutual support between informal carers and long-term care workers during the palliative phase and post-bereavement period; (2) within group homes for people living with disabilities, developing a person-centered model to strengthen mutual support and communication between informal carers and long-term care workers; and (3) strengthening support for informal carers during the waiting period for nursing home admission to reduce frustration, anxiety and stress.
Project partners will work across two sites with distinct areas of focus: (1) in collaboration with a disability care provider, improving relationships, communication and coordination between informal carers and long-term care workers in group home settings; and (2) in collaboration with a long-term care provider and an umbrella organization of local citizen-led initiatives, exploring ways to improve coordination and mutual support around initiatives that support ageing in place and strengthen the supportive capacity of local communities for care recipients and their informal carers.
Resilience
Measured using the 2-item Connor-Davidson Resilience Scale (CD-RISC-2). Items are scored on a 5-point Likert scale (0 = "not true at all" to 4 = "true nearly all of the time"). Scoring: sum of items (range 0-8); higher scores indicate greater resilience.
Time frame: Baseline (within 1 month before the intervention) and follow-up (within 1 month after completion of the intervention).
Mental wellbeing
Measured using the 7-item Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS). Items are scored on a 5-point Likert scale (1 = "none of the time" to 5 = "all of the time", looking at the past two weeks). Scoring: sum items (range 7-35); higher scores indicate better mental wellbeing.
Time frame: Baseline (within 1 month before the intervention) and follow-up (within 1 month after completion of the intervention).
Plan to share: Yes — De-identified individual participant data underlying the results reported in publications arising from this study (including questionnaire data collected at baseline and follow-up) will be made available under controlled access. Direct identifiers will not be shared. Qualitative interview and focus group data will generally not be shared because complete de-identification cannot be guaranteed and disclosure may compromise participant confidentiality.
Supporting information: Study protocol, Statistical analysis plan
Time frame: De-identified individual participant data and supporting documentation will become available following publication of the primary study results. Data will remain available for at least 10 years, subject to the policies of the hosting repository and applicable legal and ethical requirements.
Access criteria: De-identified individual participant data and supporting documentation will be available to qualified researchers for scientifically sound research purposes. Data will be deposited in Zenodo. Access to individual participant data will be provided under controlled access following review of a data access request and, where applicable, a data sharing agreement, in accordance with participants' informed consent, the EU General Data Protection Regulation (GDPR), and applicable national data protection legislation.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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VU University of Amsterdam