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Not yet recruiting NCT07504159

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

Observational Older People With Home Care Staff Working With Older People in Home Care

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Older People With Home Care, Staff Working With Older People in Home Care. Basic parameters: from 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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?

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.

Primary outcome measures

  • 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).]
  • 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).]
Secondary outcome measures (12)
  • 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).]
  • 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).]
  • 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).]
  • 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).]
  • 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).]
  • 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).]
  • 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).]
  • 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).]
  • 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).]
  • 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).]
  • 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).]
  • 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).]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Sweden · 1 center
  • University of Gävle — Gävle

Identifiers

NCT: NCT07504159 · HIG-FORSK 2026/32

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗