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Older People With Home CareNCT07504159

Elderly Care in Transition - the Older Persons' and the Staff's Perspective

An observational study of Older People With Home Care and Staff Working With Older People in Home Care, run by University of Gavle at 1 site in Sweden.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 70 years and older
How many people
1,980 participants
Where
1 siteSweden
Study dates
1 Apr 2026to 31 Oct 2028
Phase
Observational
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 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: 1. Older people 70 years or more in two municipalities who have home care/service. 2. staff working in home care/service in these two municipalities

Who may be able to join

  • age 70+
  • having home care and
  • able to respond to a survey.
  • home care staff in the two municipalities, no age limits for the staff.

Who cannot join

  • those with only food distribution and/or
  • those with only alarms.
  • those on leave and
  • those on short-term/hourly employees.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Maria Engström Professor, PhD contact

+4626648215

maria.engstrom@hig.se

Annika Nilsson Professor, PhD contact

+4626648282

Annika.Nilsson@hig.se

Sweden1 site
  • University of Gävle

    Gävle, 80176

    Maria Engström Professor, Professor, +4626648215, maria.engstrom@hig.se

    Annika Nilsson Professor, PhD, +4626648282, Annika.Nilsson@hig.se

Other trials in Sweden

About this study

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.

Read more

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?

Read the detailed description

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.

Keywords
Elderly care in transition, person-centered care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07504159
Study groupRoleWhat they receive
Older people intervention groupThe intervention/changed working method consists of a transition to measures without individual needs assessment by a social welfare officer, and staff training. Training: changes in legislation (Social Services Act 2025:400), changed working method focusing person-centered care, participation, accessibility, health promotion and prevention, and motivational interviews. Every person with home care will have a permanent care contact who has undergone training. A new preventive unit will be formed with the mission to guide citizens to the right type of measures or other forms of support and to ensure that the interventions are designed based on the individual's needs and resources in an initial stage. The unit will work in an outreach and preventive manner. The municipality is responsible for the intervention, which is implemented regardless of the researchers' participation or not and the researchers follow the project with survey data and interviews.
Older people comparison groupIn the comparison municipality, certain changes are also taking place, but to a lesser extent. Measures without individual needs assessment by a social welfare officer are not planned on any large scale within the next year. However, preventive and health-promoting activities are being expanded, but on a smaller scale.
Staff intervention groupThe intervention/changed working method consists of a transition to measures without individual needs assessment by a social welfare officer, and staff training. Training: changes in legislation (Social Services Act 2025:400), changed working method focusing person-centered care, participation, accessibility, health promotion and prevention, and motivational interviews. Every person with home care will have a permanent care contact who has undergone training. A new preventive unit will be formed with the mission to guide citizens to the right type of measures or other forms of support and to ensure that the interventions are designed based on the individual's needs and resources in an initial stage. The unit will work in an outreach and preventive manner. The municipality is responsible for the intervention, which is implemented regardless of the researchers' participation or not and the researchers follow the project with survey data and interviews.
Staff comparison groupIn the comparison municipality, certain changes are also taking place, but to a lesser extent. Measures without individual needs assessment by a social welfare officer are not planned on any large scale within the next year. However, preventive and health-promoting activities are being expanded, but on a smaller scale.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Older peoples' rating of Person-centered care

    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.

    Measured: Data collection before the changes (pre-), and thereafter 12 and 24 months after the first data collection (post data collection).

  2. Staff-rated person-centered care

    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.

    Measured: Data collection before the changes (pre-), and thereafter 12 and 24 months after the first data collection (post data collection).

Secondary outcomes (15)
  1. Older peoples' rating of their health/wellbeing -EQ-VAS

    Survey, scale for health EuroQol - (EQ)- VAS, scores 0-100, higher scores better health

    Measured: Data collection before the changes (pre-), and thereafter 12 and 24 months after the first data collection (post data collection).

  2. Older peoples' rating of their health/wellbeing - Life satisfaction

    Survey, the Life Satisfaction Questionnaire with scores 0-100, higher scores a more desirable outcome for wellbeing

    Measured: Data collection before the changes (pre-), and thereafter 12 and 24 months after the first data collection (post data collection).

  3. Older peoples' rating of their health/wellbeing - Depression

    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"),

    Measured: Data collection before the changes (pre-), and thereafter 12 and 24 months after the first data collection (post data collection).

  4. Older peoples' rating of their health/wellbeing - Anxiety

    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").

    Measured: Data collection before the changes (pre-), and thereafter 12 and 24 months after the first data collection (post data collection).

  5. Older peoples' rating of their health/wellbeing - Loneliness

    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).

    Measured: Data collection before the changes (pre-), and thereafter 12 and 24 months after the first data collection (post data collection).

  6. Staff-rated quality of working life - Structural conditions/empowerment

    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).

    Measured: Data collection before the changes (pre-), and thereafter 12 and 24 months after the first data collection (post data collection).

  7. Staff-rated quality of working life - Thriving

    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.

    Measured: Data collection before the changes (pre-), and thereafter 12 and 24 months after the first data collection (post data collection).

  8. Staff-rated quality of working life - Stress symptoms

    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.

    Measured: Data collection before the changes (pre-), and thereafter 12 and 24 months after the first data collection (post data collection).

  9. Staff-rated quality of working life - Intention to leave

    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

    Measured: Data collection before the changes (pre-), and thereafter 12 and 24 months after the first data collection (post data collection).

  10. Staff-rated quality of working life - Job satisfaction

    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

    Measured: Data collection before the changes (pre-), and thereafter 12 and 24 months after the first data collection (post data collection).

  11. Staff-rated quality of working life - Psychological empowerment

    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.

    Measured: Data collection before the changes (pre-), and thereafter 12 and 24 months after the first data collection (post data collection).

  12. Staff-rated quality of working life - Work-life conflict

    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.

    Measured: Data collection before the changes (pre-), and thereafter 12 and 24 months after the first data collection (post data collection).

  13. Staff-rated quality of working life - Quantitative demands

    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.

    Measured: Data collection before the changes (pre-), and thereafter 12 and 24 months after the first data collection (post data collection).

  14. Staff-rated quality of working life - Emotional demands

    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.

    Measured: Data collection before the changes (pre-), and thereafter 12 and 24 months after the first data collection (post data collection).

  15. Staff-rated quality of working life - Burnout

    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.

    Measured: Data collection before the changes (pre-), and thereafter 12 and 24 months after the first data collection (post data collection).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2026
  2. Study start1 Apr 2026 (estimated)
  3. Primary completion31 Oct 2028 (estimated)
  4. Study completion31 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
1,980 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07504159
Sponsor's protocol ID
HIG-FORSK 2026/32
Status last verified
Mar 2026
First submitted
18 Mar 2026
Last updated
31 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data set with individual data are not available to share due to general data protection regulations (GDPR), and in line with the ethics application.

Questions about this trial

What is this clinical trial studying?

An observational study of Older People With Home Care and Staff Working With Older People in Home Care, run by University of Gavle 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 31 Mar 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?

Contact Maria Engström Professor, PhD (+4626648215, maria.engstrom@hig.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. 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 31 Mar 2026.

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