- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07508878
Elderly Care in Transition - Perspectives of the Elderly and the Staff
Elderly Care in Transition - The Elderlys' and the Staffs' Perspective on Person-centered Care, Environment, Health and Well-being
Elderly care in Sweden faces several significant challenges. The number of older people is increasing at the same time as there are fewer of working age. Elderly care staff, such as nurses, care assistants and nurses, have on average more sick days than many other professional groups and often experience high work-related stress. In some municipalities, there are also problems with high staff turnover and a lack of formal competence. At the same time, research shows that many employees experience work in elderly care as meaningful and valuable. Taking advantage of and strengthening these positive aspects is central to creating good conditions for the health and well-being of staff and for the quality of care and care for older people. An important area of development in elderly care is person-centred care, which means that care is based on the individual person's needs, wishes, life history and resources. Person-centred practice emphasises the relationship between the older person, the staff and, if the person so wishes, relatives. Although person-centered care is often seen as an obvious part of good care, research shows that it is not fully implemented in practice and that the introduction of person-centered working methods can be complex and demanding.
This study is being carried out in collaboration between municipalities and the University of Gävle and is linked to the establishment of nursing homes for the elderly that will function as academic nursing homes. In these nursing homes, person-centered care will be a pronounced focus area. Through recurring measurements, the activities will be monitored and developed in close collaboration between practice and research. The overall aim of the study is to investigate older people's experience of academic nursing homes with a focus on person-centered care and nursing, outdoor environment, health and well-being, and to investigate the staff's experience of person-centered working methods, learning, structural conditions and work-related well-being. The study also aims to analyze the relationship between older people's experiences of person-centered care, outdoor environment, health and well-being, both among older people living in academic nursing homes and among older people living in their own homes. The study has a longitudinal design and data will be collected at several points in time using questionnaires and interviews, which enables both statistical analyses and an in-depth understanding of the participants' experiences over time. By highlighting the perspectives of both older people and staff, the study can contribute new knowledge about how person-centered care can be developed and maintained in practice. In the long term, the results can contribute to a more health-promoting, sustainable and attractive elderly care for both older people and staff.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study aims to answer the following questions:
- What changes occur over time in the elderly's ratings of person-centered care, outdoor environment, health and well-being before and after moving to/starting an academic SÄBO and are there any differences in the ratings of person-centered care, outdoor environment, health and well-being over time between an intervention group and a comparison group?
- What changes occur over time in the staff's ratings of person-centered care, learning, structural conditions and well-being? And are there any differences compared to a comparison group?
The study has a quasi-experimental design with measurements before and after moving into a newly opened academic nursing homes (in one municipality) and transitioning to an academic nursing home (in the other municipality). Comparison is made with one or more regular nursing homes. In municipality A, 130-140 people live at the municipality's nursing homes, of which approximately 80 will live at an academic nursing homes. In municipality B, there are 116 older people living in nursing homes, of which approximately 25 will live at an academic nursing home. At each measurement, all elderly people living in nursing homes in the two municipalities will be surveyed. In total, approximately 85-90 at the academic nursing homes (60-65 in municipality A and approximately 25 in municipality B) are expected to participate and at least as many in the comparison group. Data are collected using questionnaires that include sociodemographic variables and validated instruments for health (EQ-5D-5L), well-being (LSQ), depression/anxiety (PHQ-4), loneliness (UCLA-3), frailty (TFI), person-centered care and support (PCPI-C) and outdoor environment (Perceived Restorativeness Scale and study-specific questions) before moving in/starting and approximately 6, 12 and 24 months after. Data collection is carried out by staff from a different nursing home than the one being studied.
The study also include staff from the nursing homes. The intervention group consists of 126-130 employees at the academic nursing homes (76-80 in municipality A and approximately 50 in municipality B). The comparison group consists of staff from regular nursing homes of at least the same size, which means that the study is estimated to include approximately 300-380 participants in total. Data are collected via a questionnaire before the acamdec nursing homes opens and 12 and 24 months after. The questionnaires include validated instruments for person-centered care (PCPI-S), learning and vitality (Thriving Scale), structural conditions (CWEQ II), stress and intention to leave (BIAJS), psychological empowerment (Spreitzer), work-life conflict (COPSOQ III) and a study-specific question on self-efficacy.
Quantitative data are analyzed using descriptive and analytical statistics, such as ANOVA or GEE for repeated measures and clustering. Relationships are analyzed using correlation and regression models. Non-parametric analysis methods are used when necessary. Psychometric analyses include factor analysis for construct validity and Cronbach's alpha for reliability. For translated instruments, face validity and content validity indices are also examined. The power calculation is based on the assumption that effect sizes in nursing research are usually between small and medium (Cohen's d = 0.20-0.50) (Polit & Beck, 2025). Assuming a medium effect size and a power of 0.80, a minimum of 64 participants per group is required, which is considered to be achieved in this study.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Denice Högstedt, PhD
- Phone Number: +4626645068
- Email: denice.hogstedt@hig.se
Study Contact Backup
- Name: Maria Engström, PhD
- Email: maria.engstrom@hig.se
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria - Older people:
- Living in nursing homes - academic or standard
- Able to complete a questionnaire independently or with reading assistance
Inclusion Criteria - Staff:
- Employed at an Academic nursing home or a regular nursing home (comparison unit)
- Belonging to care, nursing, or rehabilitation staff, including registered nurses, occupational therapists, and physiotherapists
- Able to complete a questionnaire
Exclusion Criteria - Older people:
- Individuals receiving only safety alarm services and/or meal delivery (no ongoing care contact)
- Individuals unable to provide informed consent
- Individuals unable to complete a questionnaire, even with reading assistance
- Individuals with acute medical conditions that make participation inappropriate (as judged by care staff)
- Individuals with severe cognitive impairment preventing meaningful participation in surveys.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Older people living in academic nursing homes - intervention group
Older people receiving municipal elder care and residing at academic nursing homes in two swedish municipalities.
Participants are exposed to an academic care model integrating evidence-based practice, systematic competence development, and collaboration with higher education institutions.
Total expected cohort size: 85-90 participants (Municipality A 60-65; Municipality B ~25).
|
This study is conducted in collaboration between two municipalities and the University of Gävle and is linked to the establishment of a new nursing home for older adults that will operate as academic nursing homes.
In one municipality, a newly built nursing hom will open as an academic nursing home, while in the other municipality an existing nursing home will be transformed into an academic unit.
Within these Academic settings, person-centred care and support will constitute a central focus, alongside the development and use of structured supervision and learning models.
All decisions regarding changes to care practices, organisational processes, or the implementation of person-centred approaches are made solely by the municipal services themselves.
The research group does not participate in operational decision-making and does not influence the practical design or delivery of care within the units.
|
|
Older people living in regular nursing homes - comparison group
Older people living in standard municipal nursing homes (non-academic) in the same municipalities.
These units represent conventional forms of residential elder care without the academic model.
Comparison units are selected to match the size of the intervention cohort.
|
|
|
Staff working in academic nursing homes - intervention group
All staff employed at the academic nursing homes in the two municipalities, including nursing assistants, registered nurses, occupational therapists, physiotherapists, and other nursing staff.
Workforce exposed to the academic model's organizational and educational framework.
Expected cohort size: 126-130 participants.
|
This study is conducted in collaboration between two municipalities and the University of Gävle and is linked to the establishment of a new nursing home for older adults that will operate as academic nursing homes.
In one municipality, a newly built nursing hom will open as an academic nursing home, while in the other municipality an existing nursing home will be transformed into an academic unit.
Within these Academic settings, person-centred care and support will constitute a central focus, alongside the development and use of structured supervision and learning models.
All decisions regarding changes to care practices, organisational processes, or the implementation of person-centred approaches are made solely by the municipal services themselves.
The research group does not participate in operational decision-making and does not influence the practical design or delivery of care within the units.
|
|
Staff working in regular nursing homes - comparison group
Staff at one or more regular nursing home in each municipality, matched in size to the intervention sites.
Represents the conventional care organization.
Comparison units are selected to match the size of the intervention cohort.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Older peoples' rating of Person-centered care
Time Frame: Baseline, 6 months, 12 months, 24 months
|
Older peoples' experiences of person-centred care measured with the Person-Centred Practice Inventory - Care (PCPI-C), covering domains such as participation, shared decision-making and respect for individual needs.
Score range: Min: 1, Max: 5. Interpretation: Higher scores = more person-centred care.
|
Baseline, 6 months, 12 months, 24 months
|
|
Person-Centred Care Practice (PCPI-S)
Time Frame: Baseline, 12 months, 24 months.
|
Staff perceptions of person-centred care practices measured using the Person-Centred Practice Inventory - Staff (PCPI-S).
The instrument assesses values, care processes, and organisational prerequisites for person-centred care.
Score Range: Min: 1-Max: 5. Higher scores indicate stronger alignment with person-centred principles.
|
Baseline, 12 months, 24 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Well-being
Time Frame: Baseline, 6 months, 12 months, 24 months.
|
Self-reported well-being and life satisfaction measured with LSQ, covering domains such as physical and mental well-being, social relations, and activities.
Higher scores indicate greater life satisfaction.
Score range: Min: 1-Max: 6. Interpretation: Higher scores = better well-being.
|
Baseline, 6 months, 12 months, 24 months.
|
|
Symptoms of Depression and Anxiety
Time Frame: Baseline, 6 months, 12 months, 24 months
|
Psychological distress measured with the 4-item Patient Health Questionnaire (PHQ-4), capturing core symptoms of anxiety and depression.
Score Range: Min: 0 - Max: 12. Interpretation: Higher scores = worse psychological distress.
|
Baseline, 6 months, 12 months, 24 months
|
|
Health - EQ-5D-5L Index Score
Time Frame: Baseline, 6 months, 12 months, 24 months
|
Overall health status measured using the EQ-5D-5L instrument, including five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression).
Outcomes reflect self-reported health.
Score Range from 0 (health states worse than death, depending on valuation set) to 1.00.
Interpretation: Higher scores = better health.
|
Baseline, 6 months, 12 months, 24 months
|
|
Health - EQ-5D-5L Visual Analogue Scale (VAS)
Time Frame: Baseline, 6 months, 12 months, 24 months.
|
Self-rated health on a visual analogue scale ranging from 0 to 100.
Score range from 0 (worst imaginable health) to 100 (best imaginable health).
Interpretation: Higher scores = better health.
|
Baseline, 6 months, 12 months, 24 months.
|
|
Frailty
Time Frame: Baseline, 6 months, 12 months, 24 months.
|
Frailty status assessed using the Tilburg Frailty Indicator (TFI), capturing physical, psychological, and social aspects of frailty.
Score Range: Min: 0 - Max: 15.
Higher scores indicate higher frailty.
|
Baseline, 6 months, 12 months, 24 months.
|
|
Outdoor environment
Time Frame: Baseline, 3 months, 12 months, 24 months.
|
Perceptions of how restorative, supportive, and health-promoting the outdoor environment is, measured using the Perceived Restorativeness Scale together with study-specific questions related to accessibility, usability, and perceived safety.
Score Range: Min: 1 - Max: 5. Interpretation: Higher scores = greater perceived restorativeness.
|
Baseline, 3 months, 12 months, 24 months.
|
|
Thriving at Work
Time Frame: Baseline, 12 months, 24 months
|
Employees' sense of vitality and learning at work measured using the Thriving Scale, capturing feelings of growth, energy, and engagement.
Higher scores indicate better workplace thriving.
Score Range: Min: 1-Max: 7. Interpretation: Higher scores = greater thriving.
|
Baseline, 12 months, 24 months
|
|
Structural Empowerment / Work Conditions
Time Frame: Baseline, 12 months, 24 months.
|
Organisational conditions enabling effective work, including access to information, support, resources, and opportunities.
Measured with the CWEQ II.
Higher scores reflect stronger structural empowerment.
Score Range: Min: 6 -Max: 30.
Interpretation: Higher scores = greater access to structural empowerment.
|
Baseline, 12 months, 24 months.
|
|
Stress Symptoms and Intention to Leave
Time Frame: Baseline, 12 months, 24 months.
|
Affective job satisfaction and emotional responses related to job strain, including intention to leave the workplace. Measured with BIAJS. Score Range: Min: 1 - Max: 5. Interpretation: Higher scores = greater affective job satisfaction (lower intention to leave).Lower satisfaction and higher strain scores may indicate elevated turnover risk. |
Baseline, 12 months, 24 months.
|
|
Psychological Empowerment
Time Frame: Baseline, 12 months, 24 months.
|
Self-perceived meaning, competence, self-determination, and impact at work, measured using Spreitzer's Psychological Empowerment Scale.
Score Range: Min: 1 - Max: 7. Higher scores reflect greater psychological empowerment.
|
Baseline, 12 months, 24 months.
|
|
Work-Life Conflict
Time Frame: Baseline, 12 months, 24 months.
|
Perceived conflict between work and private life measured using the Work-Life Conflict subscale of COPSOQ III.
Score Range: Min: 0 - Max: 100.
Higher scores indicate greater conflict and reduced balance.
|
Baseline, 12 months, 24 months.
|
|
Self-Efficacy
Time Frame: Baseline, 12 months, 24 months
|
A single study-specific question assessing staff confidence in their ability to manage work tasks and adapt to changes related to the Academic model.
Score Range: Min: 1 - Max: 7. Higher scores indicate greater self-efficacy.
|
Baseline, 12 months, 24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Maria Engström, PhD, University of Gävle
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
Other Study ID Numbers
- UGavle
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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