- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07708649
Evaluating Practices That Foster Care Partnerships and Wellbeing Among Informal Carers and Long-term Care Workers (WELLCARE)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ludo M Glimmerveen, PhD
- Phone Number: +31616824480
- Email: l.m.glimmerveen@vu.nl
Study Locations
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Zittau, Germany
- Hochschule Zittau/Görlitz
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Contact:
- Andreas Hoff
- Phone Number: +49 3583 612-0
- Email: A.Hoff@hszg.de
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Ancona, Italy
- INRCA
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Contact:
- Marco Socci
- Phone Number: +39 071 8004786
- Email: M.Socci@inrca.it
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Amsterdam, Netherlands
- Vrije Universiteit Amsterdam
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Contact:
- Ludo Glimmerveen
- Phone Number: +31616824480
- Email: l.m.glimmerveen@vu.nl
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Ljubljana, Slovenia
- University of Ljubljana
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Contact:
- Valentina Hlebec
- Phone Number: +386 1 58 05 248
- Email: Valentina.Hlebec@fdv.uni-lj.si
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Kalmar, Sweden
- Linneaus University
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Contact:
- Elizabeth Hanson
- Phone Number: +46 703614846
- Email: elizabeth.hanson@lnu.se
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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:
- 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;
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);
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Informal carers
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
|
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.
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Other: Long-term care workers
adults (≥18 years), working in home and/or residential care settings with people with LTC needs
|
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.
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Other: Care recipients
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.
|
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.
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Other: Other stakeholders
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Resilience
Time Frame: Baseline (within 1 month before the intervention) and follow-up (within 1 month after completion of the intervention).
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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.
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Baseline (within 1 month before the intervention) and follow-up (within 1 month after completion of the intervention).
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Mental wellbeing
Time Frame: Baseline (within 1 month before the intervention) and follow-up (within 1 month after completion of the intervention).
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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.
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Baseline (within 1 month before the intervention) and follow-up (within 1 month after completion of the intervention).
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Elizabeth J Hanson, PhD, Linnaeus University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- WELLCARE-WP3-Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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