NCT07708649

Brief 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. 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.

Trial Health

70
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Jan 2027

Shorter than P25 for not_applicable

Geographic Reach
5 countries

5 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 16, 2026

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

July 16, 2026

Status Verified

July 1, 2026

Enrollment Period

8 months

First QC Date

June 25, 2026

Last Update Submit

July 13, 2026

Conditions

Keywords

informal carercaregiverslong-term care workermental wellbeingresilencepartnershipcollaborationprofessional

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline (within 1 month before the intervention) and follow-up (within 1 month after completion of the intervention).

Study Arms (4)

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

Other: Solution Prototype in GermanyOther: Solution Prototype in ItalyOther: Solution Prototype in SloveniaOther: Solution Prototype in SwedenOther: 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

Other: Solution Prototype in ItalyOther: Solution Prototype in SloveniaOther: Solution Prototype in SwedenOther: 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.

Other: Solution Prototype in ItalyOther: Solution Prototype in SloveniaOther: Solution Prototype in SwedenOther: 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.

Other: Solution Prototype in GermanyOther: Solution Prototype in ItalyOther: Solution Prototype in SloveniaOther: Solution Prototype in SwedenOther: Solution Prototype in the Netherlands

Interventions

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.

Care recipientsInformal carersLong-term care workersOther stakeholders

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.

Informal carersOther stakeholders

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.

Care recipientsInformal carersLong-term care workersOther stakeholders

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.

Care recipientsInformal carersLong-term care workersOther stakeholders

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.

Care recipientsInformal carersLong-term care workersOther stakeholders

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • 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;

You may not qualify if:

  • 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);
  • only being involved in the provision or receiving of short-term or acute care (i.e., not long-term care);

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hochschule Zittau/Görlitz

Zittau, Germany

Location

INRCA

Ancona, Italy

Location

Vrije Universiteit Amsterdam

Amsterdam, Netherlands

Location

University of Ljubljana

Ljubljana, Slovenia

Location

Linneaus University

Kalmar, Sweden

Location

Related Links

Study Officials

  • Elizabeth J Hanson, PhD

    Linnaeus University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ludo M Glimmerveen, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor & Work Package leader

Study Record Dates

First Submitted

June 25, 2026

First Posted

July 16, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

July 16, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
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.

Locations