University of Gävle
Gävle, 80176, Sweden
Location contact
Annika Nilsson Professor, PhD
CONTACT
Maria Engström Professor, Professor
CONTACT
Not Yet Recruiting
NCT Number: NCT07504159
Elderly Care in Transition - the Older Persons' and the Staff's Perspective
Elderly care has and is facing several challenges with an increasing number of older people and fewer of working age. Strengthening the positive aspects will be central and creating good conditions for older people and staff for high quality care. Elderly care where both staff and the older people enjoy a health-promoting, preventive and person-centered approach and with good accessibility to services that facilitate faster transitions.
In one of the municipalities in this research project, they will introduce measures without individual needs assessment by an social welfare officer and they will carry out a training program for staff. The training will focus on changes in legislation (SoL 2025:400), changed working methods with a focus on the person and their needs (person-centered approach, participation, accessibility, health promotion and prevention) and motivational interviews. Every person with elderly care will have a permanent care contact who has undergone the training. A new preventive unit will be formed. The project is part of a larger program at the University of Gävle where the focus is on person-centered care for older people.
In the other municipality (comparison) certain changes are also taking place but to a lesser extent, interventions without individual needs assessment are not planned within the next year on any large scale. On the other hand, preventive and health-promoting activities are being expanded, but on a smaller scale.
The changes are the responsibility of the municipalities and the researchers intend to follow the changes that are taking place and has nothing to do with the changes themselves. Questionnaires will be given to older people covered by home care in two municipalities (one where the changes are taking place and a comparison municipality) and to the staff working in home care before and after the changes have taken place.
The overall aim of the study is to investigate 1) the experience of older people and 2) staff of a changed way of working in home care in one of the municipalities and compare it with a municipality where smaller changes are taking place. In addition, to study the relationship between estimates of person-centered care/service, quality of care, health and well-being in elderly care for the older people and the relationship between estimates of person-centered care/service, quality of care and quality of working life for the staff.
• What changes occur over time
1. in older peoples' rating of person-centered care/service, quality of care/service, health and well-being before and after the introduction of the new working method in one of the municipalities and are there any differences in these variables over time compared to another municipality where minor changes are implemented? 2. in staff-rated person-centered care/service, quality of care/service, and quality of working life, and are there any differences compared to a comparison municipality?
The main question that the study aims to answer is: are there any changes in person-centered care, as rated by older people and staff, over time in the municipality with changed working methods within home care and compared to a comparison group/municipality?
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Trial opening soon.
Get NotifiedKey information
Age range
70 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
Power is calculated based on a small (0.20) to medium (0.50) effect size (Cohen's d), which is common in nursing. On average, in nursing, an effect size of 0.35 has emerged, corresponding to a need for 129 participants in each group with a power of 0.80 (Polit and Beck 2025) (394 small effect and 64 medium).
Older people: We survey everyone with home care in both municipalities. The approximate number of people with home care in January/February 2026 in the intervention municipality was approximately 700, and the comparison municipality 700, which may of course change. Measurements will be taken before the change and after (12 and 24 months after the first measurement). Estimated response rate 50% and additional dropouts are included in measurements over time. In summary, our estimate is approximately 300-400 participants over time per municipality, which gives us sufficient basis for the average effect size that has been measured in nursing.
Staff : All staff in the municipality where the intervention is implemented who work with care/service for the elderly in their own homes (approximately 150 assistant nurses, 50 care assistants) will be asked about participation, as well as all staff - equivalent - in a comparison municipality (approximately 380). For power in this study, the same calculation is used as for the elderly, which means that we need approximately 129 participants in each group.
Data will be analyzed using analytical statistics, e.g., ANOVA, ANCOVA or GEE (Fitzmaurice et al., 2011) (to account for clustering) to study the intervention/change in behavior over time or non-parametric tests depending on whether the data is normally distributed or not. For analyses of relationships, bivariate correlation analyses and multiple regression analyses.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- older people:
- age 70+
- having home care and
- able to respond to a survey.
Exclusion criteria
- older people:
- those with only food distribution and/or
- those with only alarms.
Inclusion criteria
- staff:
- home care staff in the two municipalities, no age limits for the staff.
Exclusion criteria
- staff:
- those on leave and
- those on short-term/hourly employees.
Treatment and study plan
Primary outcomes
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Older peoples' rating of Person-centered care
Time frame: Data collection before the changes (pre-), and thereafter 12 and 24 months after the first data collection (post data collection).
The scale Person-Centred Practice Inventory - Care [PCPI-C] will be used to measure older peoples' ratings of person-centered care,18 items, each rated on a 5- point Likert scale from strongly disagree (1) to strongly agree (5), mean score is calculated and a higher score means more person-centred care.
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Staff-rated person-centered care
Time frame: Data collection before the changes (pre-), and thereafter 12 and 24 months after the first data collection (post data collection).
The Person-Centred Practice Inventory - Staff (PCPI-S) will be used to measure staff-rated person-centred care, 59 items, 5-point response alternatives, mean score is calculated and a higher score represents a more person-centred care.
Secondary outcomes
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Older peoples' rating of their health/wellbeing -EQ-VAS
Time frame: Data collection before the changes (pre-), and thereafter 12 and 24 months after the first data collection (post data collection).
Survey, scale for health EuroQol - (EQ)- VAS, scores 0-100, higher scores better health
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Older peoples' rating of their health/wellbeing - Life satisfaction
Time frame: Data collection before the changes (pre-), and thereafter 12 and 24 months after the first data collection (post data collection).
Survey, the Life Satisfaction Questionnaire with scores 0-100, higher scores a more desirable outcome for wellbeing
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Older peoples' rating of their health/wellbeing - Depression
Time frame: Data collection before the changes (pre-), and thereafter 12 and 24 months after the first data collection (post data collection).
Survey, the Patient Health Questionnaire PHQ-2 will be used that gives a score for depression 0-6, higher score more depressive symptoms, each item rated from 0 ( "not at all") to 3 ( "nearly every day"),
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Older peoples' rating of their health/wellbeing - Anxiety
Time frame: Data collection before the changes (pre-), and thereafter 12 and 24 months after the first data collection (post data collection).
Survey, the Generalized anxiety disorder scale GAD-2 will be used that gives a score for anxiety 0-6, higher score more anxiety symptoms, each item rated from 0 ( "not at all") to 3 ( "nearly every day").
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Older peoples' rating of their health/wellbeing - Loneliness
Time frame: Data collection before the changes (pre-), and thereafter 12 and 24 months after the first data collection (post data collection).
The UCLA 3-item loneliness scale will be used to measure loneliness. Higher scores indicating more loneliness. Each item rated on a 3-popint scale 1)hardly ever 2) some of the time, 3)often. Total score of the scale is the sum of the three items ( scale range 3-9).
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Staff-rated quality of working life - Structural conditions/empowerment
Time frame: Data collection before the changes (pre-), and thereafter 12 and 24 months after the first data collection (post data collection).
To measure structural conditions/empowerment the 19-item Condition of work effectiveness scale-II (CWEQ-II) will be used. The total score for the scale range from 6 to 30, higher scores representing better structural conditions. Response alternatives each item are 5-grade (1. None to 5. A lot).
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Staff-rated quality of working life - Thriving
Time frame: Data collection before the changes (pre-), and thereafter 12 and 24 months after the first data collection (post data collection).
The 10-item Thriving scale will be used to measure thriving, 5-point response alternatives. For total score the mean is calculated and a higher score means higher thriving.
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Staff-rated quality of working life - Stress symptoms
Time frame: Data collection before the changes (pre-), and thereafter 12 and 24 months after the first data collection (post data collection).
Stress symptoms will be measured using the Psychosomatic Health Aspects Scale, one factor 10 items. Response alternatives are 5-grade [1) very often, 2) Quite often 3) Sometimes 4) Seldom 5) Never]. Scores from the ten items are averaged for factor score, and higher scores represent more stress symptoms.
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Staff-rated quality of working life - Intention to leave
Time frame: Data collection before the changes (pre-), and thereafter 12 and 24 months after the first data collection (post data collection).
One question on intention to leave from the Satisfaction with work questionnaires, 'Have you recently seriously considered quitting your job on the unit because you don't enjoy it?', with response alternatives 1) No, 2) Yes, but I have not done anything and 3) Yes, and I have taken action
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Staff-rated quality of working life - Job satisfaction
Time frame: Data collection before the changes (pre-), and thereafter 12 and 24 months after the first data collection (post data collection).
The 4-item Brief Index of affective job satisfaction will be used. Items are averaged to get the total score and higher scores represent higher job satisfaction
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Staff-rated quality of working life - Psychological empowerment
Time frame: Data collection before the changes (pre-), and thereafter 12 and 24 months after the first data collection (post data collection).
Spreitzer's Psychological Empowerment scale will be used, 12 items that are averaged and higher scores representing higher psychological empowerment. 7-point response alternatives for each item.
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Staff-rated quality of working life - Work-life conflict
Time frame: Data collection before the changes (pre-), and thereafter 12 and 24 months after the first data collection (post data collection).
The factor work-life conflict from the Copenhagen Psychosocial Questionnaire COPSOQ III will be used, three items that are averaged, response alternatives on a 5-point scale.
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Staff-rated quality of working life - Quantitative demands
Time frame: Data collection before the changes (pre-), and thereafter 12 and 24 months after the first data collection (post data collection).
The factor quantitative demands from the Copenhagen Psychosocial Questionnaire COPSOQ III will be used, three items that are averaged, response alternatives on a 5-point scale.
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Staff-rated quality of working life - Emotional demands
Time frame: Data collection before the changes (pre-), and thereafter 12 and 24 months after the first data collection (post data collection).
The factor emotional demands from the Copenhagen Psychosocial Questionnaire COPSOQ III will be used, two items that are averaged, response alternatives on a 5-point scale.
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Staff-rated quality of working life - Burnout
Time frame: Data collection before the changes (pre-), and thereafter 12 and 24 months after the first data collection (post data collection).
The factor burnout from the Copenhagen Psychosocial Questionnaire COPSOQ III will be used, three items that are averaged, response alternatives on a 5-point scale.
Other outcomes
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Older peoples' rating on Quality of care
Time frame: Data collection before the changes (pre-), and thereafter 12 and 24 months after the first data collection (post data collection).
Study specific questions on how the older people rate the care they receive
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Staff-rated quality of care
Time frame: Data collection before the changes (pre-), and thereafter 12 and 24 months after the first data collection (post data collection).
Study-specific questions are used for self-efficacy, accessibility, preventive measures, health promotion, and satisfaction with care/service.
Study contacts
Contact information is provided by the study sponsor or research team.
Annika Nilsson Professor, PhD
CONTACT
Maria Engström Professor, PhD
CONTACT
Sponsors and collaborators
Lead sponsor
University of Gavle
Other
Registry information
Important dates
- Study start
- 2026
- Primary completion
- 2028
- Study completion
- 2028
- First posted
- Mar 31, 2026
- Registry last updated
- Mar 31, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.