To Develop, Test, Implement and Evaluate a Model for Person-centred Care for Older People at Two Academic Residential Care FacilitiesProFoUND PCCNCT07921953
ProFoUND PCC= A Program For a Userbased Nursing Development in Person-Centered Care, is a Project That Aims to Develop, Test and Evaluate Effects of a Co-created Intervention to Increase Person-centred Care in Residential Care Settings for Older People.
A study testing A program for a userbased nursing development in person-centred care in people with To Develop, Test, Implement and Evaluate a Model for Person-centred Care for Older People at Two Academic Residential Care Facilities, run by Mälardalen University at 1 site in Sweden.
Trial summary
The aim of this project is to develop, test and evaluate effects of a co-created intervention to increase person-centred care in residential care settings for older people. The project builds on the following sequential studies with the following research questions (RQ): What are the perceptions of older people… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- To Develop, Test, Implement and Evaluate a Model for Person-centred Care for Older People at Two Academic Residential Care Facilities
- What is being tested?
- A program for a userbased nursing development in person-centred care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSweden
- Study dates
- 4 Sep 2025to Dec 2028
- 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
- Aged 65 years or older.
- Residing in one of the two participating academic nursing homes.
- Aged 18 years or older.
- Relative of a resident living in one of the participating nursing homes.
- Aged 18 years or older.
- Employed in social care or healthcare at one of the participating nursing homes.
Who cannot join
- Current condition (e.g., severe fatigue, pain, or acute illness) makes participation unduly burdensome.
- Unable to provide informed consent for the specific study activity despite adapted information and support.
- Participation may be postponed or discontinued if the individual's condition changes during data collection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: ProFoUND PCC= A Program For a Userbased Nursing Development in Person-Centered Care
The aim of this project is to develop, test and evaluate effects of a co-created intervention to increase person-centred care in residential care settings for older people.
The project builds on the following sequential studies with the following research questions (RQ):
Read more
What are the perceptions of older people, living at residential care facilities, regarding person-centeredness in terms of perceived health, contact with staff, execution of care, treatment from staff, security, social activities, care at the facility, and assistive devices?
1.1 Are there differences in these perceptions between those with dementia and those without?
1.21.1 Are there differences between those in residential care facilities for older people and those in ordinary housing with home care services?
What are the essential components of person-centered care in a residential care setting for older people, from the perspectives of older people, next of kins, social- and healthcare staff, nursing home managers, and community stakeholders?
How can a person-centered care intervention in residential care be designed and implemented?
What are the effects of a person-centered care intervention in residential care on the thriving, health and quality of life of older people, and satisfaction of care of older people and next of kins, as well as job satisfaction in staff?
What are the experiences and meanings of a person-centered care intervention in residential care of the older people, next of kins and staff?
What are the effects of a person-centered care intervention in residential care on older people's perceptions of person-centeredness in terms of perceived health, contact with staff, execution of care, treatment from staff, security, social activities, care at the facility, and assistive devices?
6.1. Are there differences in these perceptions between those with dementia and those without?
What are the possible implementation costs, intervention costs, and downstream costs and benefits of a person-centered care intervention in residential care, including staff turnover, sick leave, and care? -health economy estimates
What strengths or weaknesses have been identified in the implementation of the ProFoUND model and what revisions needs to be done?
Read the detailed description
BACKGROUND It is well known that the older population is increasing rapidly worldwide. Many individuals have a healthy life in higher ages, while some will live longer with multimorbidity and a need of advanced care in home care and residential care facilities (RCFs). In Sweden, high-quality residential care is commonly captured in terms of Person-centred care (PCC), and guidelines and strategy document such as the statue reports of care of older people3 are grounded in PCC.
PCC is a concept fundamentally rooted in the subjective experiences of individuals requiring care and support, and builds upon the persons prevailing preferences, priorities, values, and exigencies. Operationalising a humanistic and relational ethic in care contexts, PCC provides a caring theory that outlines that all forms of care have a relational dimension that needs to be considered, and requires an ethical awareness of listening to, confirming, and responding to the needs, wants, wishes and priorities of the person that needs care. If this ethical dimension of care is prioritised and included in care, the likelihood of providing PCC increases.
Despite a growing body of evidence supporting PCC, important knowledge gaps remain regarding how and why PCC works in practice, and how such approaches can be sustained over time. PCC interventions in the care of older people show positive effects on residents' well-being yet highlights a lack of synthesis of underlying mechanisms and strategies for long-term implementation/sustainability. A review suggest that PCC-interventions need to be co-created with residents, relatives and staff and build on a person-centred foundation. Another review state that high-quality interventions need to be implemented over an extended time to identify how person-centred care can be best implemented to improve resident outcomes. A third, suggest that research need to focus on effective strategies to strengthen organisational support, including leadership development, staff retention, and resource allocation, as well as evaluate how organisational culture influences the adoption and success of person-centred care practices.
There is also a recognised need for research-based continuing education for staff, as well as for the involvement of older people and their relatives in the design and evaluation of PCC interventions. Such efforts are considered important not only for strengthening competence in PCC, but also for supporting staff well-being and maintaining high-quality care.
As a relational and value-based approach, PCC requires flexibility and responsiveness to individual needs, which contrasts with healthcare systems often characterised by task-oriented care, standardisation and time-controlled workflows. This misalignment makes PCC difficult to operationalise in everyday practice. Previous research also highlights several facilitating factors. Training and education are often emphasised as important for successful implementation. However, implementation requires more than education alone; it also depends on organisational support, facilitation, and adaptation to local conditions. Supportive leadership and interprofessional teamwork, including the involvement of patients, are likewise important for PCC. In line with this, PCC interventions need to be context-sensitive and developed in collaboration with those involved in care.
In Swedish contexts, several initiatives have aimed to implement PCC. For one, the KISAM project represents a large-scale collaboration between academia and municipal care, focusing on the implementation of national guidelines underpinned by PCC, where research and practice developed in parallel. Similarly, the U-AGE program focused on implementing PCC through development and evaluation of health-promoting living conditions for older people receiving home care and residential care. Findings from these initiatives indicate that PCC interventions are feasible and can lead to positive outcomes, such as increased thriving among residents and relatives, as well as improvements in the work environment for staff. They also highlighted how concrete strategies at organisational levels (e.g. leadership) can support the implementation of PCC in practice. However, sustaining these interventions over time has proven challenging. This has been linked to limited implementation competence within care organisations, as well as limited capacity for systematic improvement work and lack of structures for continued collaboration between care organisations and academia. As a result, practices introduced during research projects are often difficult to maintain once projects have ended, with organisations tending to revert to previous routines.
Although PCC is known to improve care processes and health outcomes, studies repeatedly show that it remains difficult to implement and sustain in RCFs for older people. This project will contribute to the literature on effects, meanings, costs and sustainability of person-centred care interventions in RCFs. The co-creation component involves close collaboration with residents, relatives, staff, managers, and community stakeholders, with particular attention to sustainable practices likely to be continued beyond the research period.
- Being tested
- A program for a userbased nursing development in person-centred care
- Keywords
- Person-centred, co-creation, co-design, academic care facilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A program for a userbased nursing development in person-centred careBehavioural
A co-created educational intervention for person-centred care (PCC) is being developed together with residents, relatives, and staff at two residential care facilities. The intervention is tailored to the unique circumstances and development needs of each facility with regard to PCC. Residents, relatives, and staff contribute their experiences and perspectives on PCC within the residential care setting, drawing on their respective roles and lived experiences.
| Study group | Role | What they receive |
|---|---|---|
| Residents living at the academic care facilities | Active comparator | Receivers of care Receives: Behavioral: A program for a userbased nursing development in person-centred care |
| Staff at the academic care facilities | Active comparator | Co-creates the education intervention, do the education and test it in the care facilities. Receives: Behavioral: A program for a userbased nursing development in person-centred care |
| Relatives to residents at the academic care facilities | Active comparator | Not described Receives: Behavioral: A program for a userbased nursing development in person-centred care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome is residents, next of kin and staff perceptions of PCC
Perceptions of person-centred care among residents, next of kin, and staff will be assessed using the Person-centred Climate Questionnaire (patient, family, and staff versions, respectively). Questionnaire scores will be collected at baseline and at 3, 6, and 12 months following the intervention. Differences between intervention and control groups will be examined using independent samples t-tests and multivariable regression analyses. Repeated measurements over time will be included in longitudinal analyses to evaluate changes associated with the intervention. Likert scales 1-5 will be used.
Measured: From enrollment to six months and 12 months after implementing the intervention, anticipated date for a primary outcome is 2028.12.31
Secondary outcomes (4)
Residents thriving, health-related quality of life among residents and staff, next of kin- satisfaction with care and staff perceptions of PCC environment, in both the intervention and the control group, before and after the intervention
Thriving will be assessed using the Thriving of Older People Assessment Scale (TOPAS). Scores will be collected at baseline and at 3, 6, and 12 months following the intervention. Differences between intervention and control groups and changes over time will be analyzed using independent samples t-tests and regression analyses.
Measured: From enrollment to six months and 12 months after implementing the intervention, anticipated date for a primary outcome is 2028.12.31
Health-related quality of life
Health-related quality of life among residents and staff will be assessed using the EQ-5D. Scores will be collected at baseline and at 3, 6, and 12 months following the intervention. Differences between intervention and control groups and changes over time will be analyzed using independent samples t-tests and regression analyses.
Measured: From enrollment to six months and 12 months after implementing the intervention, anticipated date for a primary outcome is 2028.12.31
Next-of-kin satisfaction with care
Satisfaction with care among next of kin will be assessed using the Pyramid Questionnaire. Scores will be collected at baseline and at 3, 6, and 12 months following the intervention. Differences between intervention and control groups and changes over time will be analyzed using independent samples t-tests and regression analyses.
Measured: From enrollment to six months and 12 months after implementing the intervention, anticipated date for a primary outcome is 2028.12.31
Perceptions of the person-centred care environment
Staff perceptions of the care environment will be assessed using the Swedish version of the Person-centred Care Assessment Tool (P-CAT). Scores will be collected at baseline and at 3, 6, and 12 months following the intervention. Differences between intervention and control groups and changes over time will be analyzed using independent samples t-tests and regression analyses.
Measured: From enrollment to six months and 12 months after implementing the intervention, anticipated date for a primary outcome is 2028.12.31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start4 Sep 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Develop, Test, Implement and Evaluate a Model for Person-centred Care for Older People at Two Academic Residential Care FacilitiesStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mälardalen University
- Sponsor type
- University, hospital or other
- Collaborators
- the Kamprad Family Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07921953
- Sponsor's protocol ID
- 2024/0516
- Other IDs
- 20243160
- Acronym
- ProFoUND PCC
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. The study collects sensitive personal data from older residents, family members, and staff in nursing home settings. Given the specific context and expected sample size, complete anonymization cannot be guaranteed, and there remains a risk of re-identification. In accordance with the ethical approval and to safeguard participant confidentiality, individual-level data will not be made publicly available.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ProFoUND PCC= A Program For a Userbased Nursing Development in Person-Centered Care
- ClinicalTrials.gov ID
- NCT07921953
- Acronym / sponsor ID
- ProFoUND PCC / 2024/0516
- Keywords
- Person-centred, co-creation, co-design, academic care facilities
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Mälardalen UniversityUniversity, hospital or other
- Collaborators
- the Kamprad Family Foundation
- Study start
- 4 Sep 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 6 Nov 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.
The aim of this project is to develop, test and evaluate effects of a co-created intervention to increase person-centred care in residential care settings for older people.
The project builds on the following sequential studies with the following research questions (RQ):
What are the perceptions of older people, living at residential care facilities, regarding person-centeredness in terms of perceived health, contact with staff, execution of care, treatment from staff, security, social activities, care at the facility, and assistive devices?
1.1 Are there differences in these perceptions between those with dementia and those without?
1.21.1 Are there differences between those in residential care facilities for older people and those in ordinary housing with home care services?
What are the essential components of person-centered care in a residential care setting for older people, from the perspectives of older people, next of kins, social- and healthcare staff, nursing home managers, and community stakeholders?
How can a person-centered care intervention in residential care be designed and implemented?
What are the effects of a person-centered care intervention in residential care on the thriving, health and quality of life of older people, and satisfaction of care of older people and next of kins, as well as job satisfaction in staff?
What are the experiences and meanings of a person-centered care intervention in residential care of the older people, next of kins and staff?
What are the effects of a person-centered care intervention in residential care on older people's perceptions of person-centeredness in terms of perceived health, contact with staff, execution of care, treatment from staff, security, social activities, care at the facility, and assistive devices?
6.1. Are there differences in these perceptions between those with dementia and those without?
What are the possible implementation costs, intervention costs, and downstream costs and benefits of a person-centered care intervention in residential care, including staff turnover, sick leave, and care? -health economy estimates
What strengths or weaknesses have been identified in the implementation of the ProFoUND model and what revisions needs to be done?
Detailed description
BACKGROUND It is well known that the older population is increasing rapidly worldwide. Many individuals have a healthy life in higher ages, while some will live longer with multimorbidity and a need of advanced care in home care and residential care facilities (RCFs). In Sweden, high-quality residential care is commonly captured in terms of Person-centred care (PCC), and guidelines and strategy document such as the statue reports of care of older people3 are grounded in PCC.
PCC is a concept fundamentally rooted in the subjective experiences of individuals requiring care and support, and builds upon the persons prevailing preferences, priorities, values, and exigencies. Operationalising a humanistic and relational ethic in care contexts, PCC provides a caring theory that outlines that all forms of care have a relational dimension that needs to be considered, and requires an ethical awareness of listening to, confirming, and responding to the needs, wants, wishes and priorities of the person that needs care. If this ethical dimension of care is prioritised and included in care, the likelihood of providing PCC increases.
Despite a growing body of evidence supporting PCC, important knowledge gaps remain regarding how and why PCC works in practice, and how such approaches can be sustained over time. PCC interventions in the care of older people show positive effects on residents' well-being yet highlights a lack of synthesis of underlying mechanisms and strategies for long-term implementation/sustainability. A review suggest that PCC-interventions need to be co-created with residents, relatives and staff and build on a person-centred foundation. Another review state that high-quality interventions need to be implemented over an extended time to identify how person-centred care can be best implemented to improve resident outcomes. A third, suggest that research need to focus on effective strategies to strengthen organisational support, including leadership development, staff retention, and resource allocation, as well as evaluate how organisational culture influences the adoption and success of person-centred care practices.
There is also a recognised need for research-based continuing education for staff, as well as for the involvement of older people and their relatives in the design and evaluation of PCC interventions. Such efforts are considered important not only for strengthening competence in PCC, but also for supporting staff well-being and maintaining high-quality care.
As a relational and value-based approach, PCC requires flexibility and responsiveness to individual needs, which contrasts with healthcare systems often characterised by task-oriented care, standardisation and time-controlled workflows. This misalignment makes PCC difficult to operationalise in everyday practice. Previous research also highlights several facilitating factors. Training and education are often emphasised as important for successful implementation. However, implementation requires more than education alone; it also depends on organisational support, facilitation, and adaptation to local conditions. Supportive leadership and interprofessional teamwork, including the involvement of patients, are likewise important for PCC. In line with this, PCC interventions need to be context-sensitive and developed in collaboration with those involved in care.
In Swedish contexts, several initiatives have aimed to implement PCC. For one, the KISAM project represents a large-scale collaboration between academia and municipal care, focusing on the implementation of national guidelines underpinned by PCC, where research and practice developed in parallel. Similarly, the U-AGE program focused on implementing PCC through development and evaluation of health-promoting living conditions for older people receiving home care and residential care. Findings from these initiatives indicate that PCC interventions are feasible and can lead to positive outcomes, such as increased thriving among residents and relatives, as well as improvements in the work environment for staff. They also highlighted how concrete strategies at organisational levels (e.g. leadership) can support the implementation of PCC in practice. However, sustaining these interventions over time has proven challenging. This has been linked to limited implementation competence within care organisations, as well as limited capacity for systematic improvement work and lack of structures for continued collaboration between care organisations and academia. As a result, practices introduced during research projects are often difficult to maintain once projects have ended, with organisations tending to revert to previous routines.
Although PCC is known to improve care processes and health outcomes, studies repeatedly show that it remains difficult to implement and sustain in RCFs for older people. This project will contribute to the literature on effects, meanings, costs and sustainability of person-centred care interventions in RCFs. The co-creation component involves close collaboration with residents, relatives, staff, managers, and community stakeholders, with particular attention to sustainable practices likely to be continued beyond the research period.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Residents living at the academic care facilities | Active comparator | Behavioral: A program for a userbased nursing development in person-centred careReceivers of care |
| Staff at the academic care facilities | Active comparator | Behavioral: A program for a userbased nursing development in person-centred careCo-creates the education intervention, do the education and test it in the care facilities. |
| Relatives to residents at the academic care facilities | Active comparator | Behavioral: A program for a userbased nursing development in person-centred care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 65 years or older.
- Residing in one of the two participating academic nursing homes.
- Aged 18 years or older.
- Relative of a resident living in one of the participating nursing homes.
- Aged 18 years or older.
Key exclusion criteria (3 listed)
- Current condition (e.g., severe fatigue, pain, or acute illness) makes participation unduly burdensome.
- Unable to provide informed consent for the specific study activity despite adapted information and support.
- Participation may be postponed or discontinued if the individual's condition changes during data collection.
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 |
|---|---|---|
| A program for a userbased nursing development in person-centred careA co-created educational intervention for person-centred care (PCC) is being developed together with residents, relatives, and staff at two residential care facilities. The intervention is tailored to the unique circumstances and development needs of each facility with regard to PCC. Residents, relatives, and staff contribute their experiences and perspectives on PCC within the residential care setting, drawing on their respective roles and lived experiences. | Behavioural | Relatives to residents at the academic care facilities, Residents living at the academic care facilities, Staff at the academic care facilities |
Primary outcome
Primary outcome is residents, next of kin and staff perceptions of PCC
Time frame: From enrollment to six months and 12 months after implementing the intervention, anticipated date for a primary outcome is 2028.12.31
Perceptions of person-centred care among residents, next of kin, and staff will be assessed using the Person-centred Climate Questionnaire (patient, family, and staff versions, respectively). Questionnaire scores will be collected at baseline and at 3, 6, and 12 months following the intervention. Differences between intervention and control groups will be examined using independent samples t-tests and multivariable regression analyses. Repeated measurements over time will be included in longitudinal analyses to evaluate changes associated with the intervention. Likert scales 1-5 will be used.
4 secondary outcomes
Residents thriving, health-related quality of life among residents and staff, next of kin- satisfaction with care and staff perceptions of PCC environment, in both the intervention and the control group, before and after the intervention
Time frame: From enrollment to six months and 12 months after implementing the intervention, anticipated date for a primary outcome is 2028.12.31
Health-related quality of life
Time frame: From enrollment to six months and 12 months after implementing the intervention, anticipated date for a primary outcome is 2028.12.31
Next-of-kin satisfaction with care
Time frame: From enrollment to six months and 12 months after implementing the intervention, anticipated date for a primary outcome is 2028.12.31
Perceptions of the person-centred care environment
Time frame: From enrollment to six months and 12 months after implementing the intervention, anticipated date for a primary outcome is 2028.12.31
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 6 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. The study collects sensitive personal data from older residents, family members, and staff in nursing home settings. Given the specific context and expected sample size, complete anonymization cannot be guaranteed, and there remains a risk of re-identification. In accordance with the ethical approval and to safeguard participant confidentiality, individual-level data will not be made publicly available.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A program for a userbased nursing development in person-centred care in people with To Develop, Test, Implement and Evaluate a Model for Person-centred Care for Older People at Two Academic Residential Care Facilities, run by Mälardalen University at 1 site in Sweden.
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 6 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome is residents, next of kin and staff perceptions of PCC (time frame: From enrollment to six months and 12 months after implementing the intervention, anticipated date for a primary outcome is 2028.12.31). 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 6 Nov 2026.