Mental WellbeingWELLCARENCT07708649
Evaluating Practices That Foster Care Partnerships and Wellbeing Among Informal Carers and Long-term Care Workers
A study testing Solution Prototype in Germany, Solution Prototype in Italy and Solution Prototype in Slovenia in people with Mental Wellbeing, run by VU University of Amsterdam at 5 sites in 5 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Wellbeing
- What is being tested?
- Solution Prototype in Germany, Solution Prototype in Italy and Solution Prototype in Slovenia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 1 Jan 2027to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
- employed in a long-term care setting at one of the participating research sites;
- directly involved in care provision or implementation of the new practices under study;
- For care recipients:
Show all 20Show fewer
- currently receiving care from long-term care workers and/or informal caregivers;
- requiring support with everyday personal care and/or more complex daily tasks due to ageing, chronic illness, disability or frailty;
- living in the community or in a long-term care setting included in the study;
- for other stakeholders:
- involved directly or indirectly in the planning, management, or implementation of the newly adopted practices at the research site;
- For all participants:
- aged 18 years or older;
- able to provide informed consent;
- sufficient proficiency in the local language to complete the questionnaire and/or participate in an interview;
- The exclusion criteria for recruiting participants will be...
- having a (permanent or temporary) psychiatric disorder or mental illness which makes the person unable to understand instructions and participate in the study activities;
- experiencing circumstances that would make participation unduly burdensome (e.g., acute stress or illness);
- providing care for fewer than the minimum number of hours required for inclusion; the threshold will be defined per country in a context-sensitive way, reflecting national differences and the characteristics of the implemented practices and their target populations;
- only being involved in the provision or receiving of short-term or acute care (i.e., not long-term care);
Who cannot join
None listed.
Trial locations and contacts
5 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 5 countries
Germany1 site
Hochschule Zittau/Görlitz
Zittau
Andreas Hoff, +49 3583 612-0, A.Hoff@hszg.de
Netherlands1 site
Vrije Universiteit Amsterdam
Amsterdam
Ludo Glimmerveen, +31616824480, l.m.glimmerveen@vu.nl
Slovenia1 site
University of Ljubljana
Ljubljana
Valentina Hlebec, +386 1 58 05 248, Valentina.Hlebec@fdv.uni-lj.si
Sweden1 site
Linneaus University
Kalmar
Elizabeth Hanson, +46 703614846, elizabeth.hanson@lnu.se
About this study
Official title: WELL CARE - Implementation and Evaluation Phase
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.
- Conditions
- Mental Wellbeing
- Being tested
- Solution Prototype in Germany, Solution Prototype in Italy, Solution Prototype in Slovenia, Solution Prototype in Sweden, Solution Prototype in the Netherlands
- Keywords
- informal carer, caregivers, long-term care worker, mental wellbeing, resilence, partnership, collaboration, professional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solution Prototype in GermanyOther
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.
Solution Prototype in ItalyOther
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.
Solution Prototype in SloveniaOther
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.
Solution Prototype in SwedenOther
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.
Solution Prototype in the NetherlandsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Informal carers | Other | 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 Receives: 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 |
| Long-term care workers | Other | adults (≥18 years), working in home and/or residential care settings with people with LTC needs Receives: Other: Solution Prototype in Italy; Other: Solution Prototype in Slovenia; Other: Solution Prototype in Sweden; Other: Solution Prototype in the Netherlands |
| Care recipients | Other | 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. Receives: Other: Solution Prototype in Italy; Other: Solution Prototype in Slovenia; Other: Solution Prototype in Sweden; Other: Solution Prototype in the Netherlands |
| Other stakeholders | Other | 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (within 1 month before the intervention) and follow-up (within 1 month after completion of the intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 Jan 2027 (estimated)
- Primary completionSep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental WellbeingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VU University of Amsterdam
- Sponsor type
- University, hospital or other
- Collaborators
- Linnaeus University, University of Ljubljana, Istituto Nazionale di Ricovero e Cura per Anziani, Hochschule Zittau/Görlitz, European Commission
- Responsible party
- Principal investigator, Ludo Glimmerveen, VU University of Amsterdam
- Investigators
- Elizabeth J Hanson, PhD, Principal investigator, Linnaeus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708649
- Sponsor's protocol ID
- WELLCARE-WP3-Study
- Acronym
- WELLCARE
- Status last verified
- Jul 2026
- First submitted
- 25 Jun 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WELL CARE - Implementation and Evaluation Phase
- ClinicalTrials.gov ID
- NCT07708649
- Acronym / sponsor ID
- WELLCARE / WELLCARE-WP3-Study
- Conditions
- Mental Wellbeing
- Keywords
- informal carer, caregivers, long-term care worker, mental wellbeing, resilence, partnership, collaboration, professional
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- VU University of AmsterdamUniversity, hospital or other
- Collaborators
- Linnaeus University, University of Ljubljana, Istituto Nazionale di Ricovero e Cura per Anziani, Hochschule Zittau/Görlitz, European Commission
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Informal carers | Other | 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 Netherlandsadults (≥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 |
| Long-term care workers | Other | Other: Solution Prototype in Italy, Other: Solution Prototype in Slovenia, Other: Solution Prototype in Sweden, Other: Solution Prototype in the Netherlandsadults (≥18 years), working in home and/or residential care settings with people with LTC needs |
| Care recipients | Other | Other: Solution Prototype in Italy, Other: Solution Prototype in Slovenia, Other: Solution Prototype in Sweden, Other: Solution Prototype in the Netherlandswill 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 stakeholders | Other | 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 NetherlandsThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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;
- employed in a long-term care setting at one of the participating research sites;
- directly involved in care provision or implementation of the new practices under study;
- currently receiving care from long-term care workers and/or informal caregivers;
- requiring support with everyday personal care and/or more complex daily tasks due to ageing, chronic illness, disability or frailty;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solution Prototype in GermanyProject 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. | Other | Informal carers, Other stakeholders |
| Solution Prototype in ItalyProject 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. | Other | Care recipients, Informal carers, Long-term care workers, Other stakeholders |
| Solution Prototype in SloveniaProject 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. | Other | Care recipients, Informal carers, Long-term care workers, Other stakeholders |
| Solution Prototype in SwedenProject 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. | Other | Care recipients, Informal carers, Long-term care workers, Other stakeholders |
| Solution Prototype in the NetherlandsProject 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. | Other | Care recipients, Informal carers, Long-term care workers, Other stakeholders |
Primary outcome
Resilience
Time frame: Baseline (within 1 month before the intervention) and follow-up (within 1 month after completion of the intervention).
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.
Mental wellbeing
Time frame: Baseline (within 1 month before the intervention) and follow-up (within 1 month after completion of the intervention).
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- WELL CARE project websiteLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth J Hanson, PhD principal investigator
Linnaeus University
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solution Prototype in Germany, Solution Prototype in Italy and Solution Prototype in Slovenia in people with Mental Wellbeing, run by VU University of Amsterdam at 5 sites in 5 countries.
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 20 inclusion and 0 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: opening soon, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Italy, Netherlands, Slovenia, Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ludo M Glimmerveen, PhD (+31616824480, l.m.glimmerveen@vu.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resilience (time frame: Baseline (within 1 month before the intervention) and follow-up (within 1 month after completion of the intervention).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2026.