An interventional study of A program for a userbased nursing development in person-centred care in To Develop, Test, Implement and Evaluate a Model for Person-centred Care for Older People at Two Academic Residential Care Facilities, sponsored by Mälardalen University. Enrolling by invitation at 1 site in Sweden. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Mälardalen University · Not applicable, Interventional, and Health services research
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?
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.
Mälardalen University is the lead sponsor of 12 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria - Residents
Inclusion Criteria - Next of Kin
Inclusion Criteria - Staff
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Receivers of care
Behavioral: A program for a userbased nursing development in person-centred care
Co-creates the education intervention, do the education and test it in the care facilities.
Behavioral: A program for a userbased nursing development in person-centred care
Behavioral: A program for a userbased nursing development in person-centred care
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.
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.
Time frame: From enrollment to six months and 12 months after implementing the intervention, anticipated date for a primary outcome is 2028.12.31
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.
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
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.
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
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.
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
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.
Time frame: From enrollment to six months and 12 months after implementing the intervention, anticipated date for a primary outcome is 2028.12.31
Tertiary outcomes focuses on staff; Sick leave
Staff sick leave will be assessed using administrative records. Differences over time between intervention and control nursing homes will be analyzed using longitudinal methods and Generalized Estimating Equations (GEE).
Time frame: From enrollment to six months and 12 months after implementing the intervention, anticipated date for a primary outcome is 2028.12.31
Tertiary Outcome Measure 2: Staff turnover
Staff turnover will be assessed using administrative records. Differences over time between intervention and control nursing homes will be analyzed using longitudinal methods and Generalized Estimating Equations (GEE).
Time frame: From enrollment to six months and 12 months after implementing the intervention, anticipated date for a primary outcome is 2028.12.31
Tertiary Outcome Measure 3, Time spent on care
Time spent on care will be assessed using a study-specific measure inspired by the Resource Utilization in Dementia (RUD) instrument. Differences over time between intervention and control groups will be analyzed using longitudinal methods and Generalized Estimating Equations (GEE).
Time frame: From enrollment to six months and 12 months after implementing the intervention, anticipated date for a primary outcome is 2028.12.31
Tertiary Outcome Measure 4, Job satisfaction
Job satisfaction among staff will be assessed using the Demand-Control-Support 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.
Time frame: From enrollment to six months and 12 months after implementing the intervention, anticipated date for a primary outcome is 2028.12.31
Tertiary Outcome Measure 5, Stress of conscience
Stress of conscience among staff will be assessed using the Stress of Conscience 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.
Time frame: From enrollment to six months and 12 months after implementing the intervention, anticipated date for a primary outcome is 2028.12.31
Tertiary Outcome Measure 6, Capabilities among residents
Capabilities will be assessed using the ICECAP-O instrument. 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.
Time frame: From enrollment to six months and 12 months after implementing the intervention, anticipated date for a primary outcome is 2028.12.31
Plan to share: 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.
No publications or documents are linked to this record.
Started Sep 2025 (actual). Primary completion is estimated for Dec 2028, 39 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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