AgingNCT02714452
A Person-centred and Thriving Promoting Care Model for Residential Aged Care
A study testing Person-centred care in people with Aging, run by Umeå University at 1 site in Sweden.
Trial summary
The overall aim of this study is to evaluate the effects, meaning and significance of a person-centred and thriving promoting model for residential aged care in Australia, Norway and Sweden. More specifically, the following research questions will be explored: 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Person-centred care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 865 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2016to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- minimum 18 years of age
- living in the facility for >1 month by the time of data collection
- visiting the residential aged care facility on a regular basis (>1/month)
- working in the residential aged care facility on a temporary and or permanent basis (>1month contract)
- have been working >1 month in the residential aged care facility by the time of data collection.
Who cannot join
- newly moved in to the facility
- visiting the facility more seldom than once a month
- working on a short-term contract
Trial locations and contacts
1 site in 1 country.
About this study
The overall aim of this study is to evaluate the effects, meaning and significance of a person-centred and thriving promoting model for residential aged care in Australia, Norway and Sweden. More specifically, the following research questions will be explored:
- Can a person-centred and thriving promoting care model increase residents' thriving, and have a positive impact on residents' perception of the caring environment?
- Can a person-centred and thriving promoting care model increase relatives' satisfaction with care, and have a positive impact on their experience of visiting their relative, and perception of the caring environment?
- Can a person-centred and thriving promoting care model increase staff's job satisfaction, decrease stress of conscience, and have a positive impact on their perception of the caring environment and person-centred care?
- What meaning and significance do relatives and staff ascribe to the intervention? The study is designed as a multi-centre, controlled group before-after design with participating sites in Victoria (Australia), Oslo (Norway) and Västerbotten (Sweden). Two residential aged care facilities at each site will be allocated to either intervention or control, in total three intervention and three control facilities divided over the three sites.
Read more
Care staff at the intervention facilities will participate in a 12-month education on how to integrate aspects of person-centredness, thriving and a caring environment into daily care practice. Participating staff will work together with their colleagues and members from the research group to create a reflective and creative learning environment that builds on and develops the staff members' clinical experience and skills, and combines it with theoretical and research-based knowledge.
At the control facilities, care staff will participate in a 2-hour lecture on the theoretical and philosophical foundations of person-centredness, thriving and a caring environment, and then continue with practice without further involvement from the research team.
Evaluation data will be collected by study specific questionnaires before the education starts, immediately after the education and at a 6-month follow-up. In addition, focus group interviews and individual interviews will be conducted with a selection of staff members and relatives at the intervention facilities to explore meaning and significance of the intervention.
- Conditions
- Aging
- Being tested
- Person-centred care
- Keywords
- Person-centred care, Thriving, Satisfaction with care, Residential aged care, Caring environment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Person-centred careBehavioural
Person-centred and thriving promoting care
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Person-centred care Receives: Behavioral: Person-centred care |
| Control | No intervention | Conventional care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in The Thriving of Older People Assessment Scale between baseline and follow-up
Data will be collected from residents at both intervention and control facilities by either self-rating or proxy-rating surveys at baseline and at 12 and 18 months follow-up
Measured: Change from baseline thriving at 12 and 18 months
Change in relatives' satisfaction with care measured by the Pyramid questionnaire
Data will be collected from relatives at both intervention and control facilities by self-rating surveys at baseline and at 12 and 18 months follow-up
Measured: Change from baseline satisfaction at 12 and 18 months
Change in staff's job satisfaction measured by the The Job satisfaction questionnaire
Data will be collected from staff at both intervention and control facilities by self-rating surveys at baseline and at 12 and 18 months follow-up
Measured: Change from baseline job satisfaction at 12 and 18 months
Secondary outcomes (4)
Change in participants' experience of the caring environment measured by The Person-centred Climate Questionnaire
Data will be collected from residents, relatives and staff at both intervention and control facilities by either self-rating or proxy-rating surveys at baseline and at 12 and 18 months follow-up
Measured: Change from baseline experience at 12 and 18 months
Change in relatives' experienced satisfaction with visiting the nursing home and their relative, measured by Visual Analogue Scales of participants' subjective experiences of 12 statements, ranging from 0 (totally disagree) to 10 (totally agree).
Data will be collected from relatives at both intervention and control facilities by self-rating surveys at baseline and at 12 and 18 months follow-up. Group level data will be aggregated using mean values of the participants' ratings.
Measured: Change from baseline satisfaction at 12 and 18 months
Change in staff's stress of conscience measured by the Stress of Conscience questionnaire
Data will be collected from staff at both intervention and control facilities by self-rating surveys at baseline and at 12 and 18 months follow-up
Measured: Change from baseline stress of conscience at 12 and 18 months
Change in staff's perception of the person-centredness of care measured by the Person-centred Care Assessment Tool
Data will be collected from staff at both intervention and control facilities by self-rating surveys at baseline and at 12 and 18 months follow-up
Measured: Change from baseline perception at 12 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 865 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, La Trobe University
- Responsible party
- Principal investigator, David Edvardsson, Umeå University
- Investigators
- David Edvardsson, Professor, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02714452
- Sponsor's protocol ID
- 2014-4016
- Status last verified
- Oct 2018
- First submitted
- 7 Mar 2016
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sjogren K, Bergland A, Kirkevold M, Lindkvist M, Lood Q, Sandman PO, Vassbo TK, Edvardsson D. Effects of a person-centred and thriving-promoting intervention on nursing home residents' experiences of thriving and person-centredness of the environment. Nurs Open. 2022 Jul;9(4):2117-2129. doi: 10.1002/nop2.1222. Epub 2022 Apr 29.
PubMed 35485234Vassbo TK, Bergland A, Kirkevold M, Lindkvist M, Lood Q, Sandman PO, Sjogren K, Edvardsson D. Effects of a person-centred and thriving-promoting intervention on nursing home staff job satisfaction: A multi-centre, non-equivalent controlled before-after study. Nurs Open. 2020 Jul 23;7(6):1787-1797. doi: 10.1002/nop2.565. eCollection 2020 Nov.
PubMed 33072363Lood Q, Sjogren K, Bergland A, Lindkvist M, Kirkevold M, Sandman PO, Edvardsson D. Effects of a staff education programme about person-centred care and promotion of thriving on relatives' satisfaction with quality of care in nursing homes: a multi-centre, non-equivalent controlled before-after trial. BMC Geriatr. 2020 Aug 1;20(1):268. doi: 10.1186/s12877-020-01677-7.
PubMed 32738880Edvardsson D, Sjogren K, Lood Q, Bergland A, Kirkevold M, Sandman PO. A person-centred and thriving-promoting intervention in nursing homes - study protocol for the U-Age nursing home multi-centre, non-equivalent controlled group before-after trial. BMC Geriatr. 2017 Jan 17;17(1):22. doi: 10.1186/s12877-016-0404-1.
PubMed 28095791
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Person-centred and Thriving Promoting Care Model for Residential Aged Care
- ClinicalTrials.gov ID
- NCT02714452
- Acronym / sponsor ID
- 2014-4016
- Conditions
- Aging
- Keywords
- Person-centred care, Thriving, Satisfaction with care, Residential aged care, Caring environment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 865 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- University of Oslo, La Trobe University
- Study start
- Mar 2016 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 21 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall aim of this study is to evaluate the effects, meaning and significance of a person-centred and thriving promoting model for residential aged care in Australia, Norway and Sweden. More specifically, the following research questions will be explored:
- Can a person-centred and thriving promoting care model increase residents' thriving, and have a positive impact on residents' perception of the caring environment?
- Can a person-centred and thriving promoting care model increase relatives' satisfaction with care, and have a positive impact on their experience of visiting their relative, and perception of the caring environment?
- Can a person-centred and thriving promoting care model increase staff's job satisfaction, decrease stress of conscience, and have a positive impact on their perception of the caring environment and person-centred care?
- What meaning and significance do relatives and staff ascribe to the intervention? The study is designed as a multi-centre, controlled group before-after design with participating sites in Victoria (Australia), Oslo (Norway) and Västerbotten (Sweden). Two residential aged care facilities at each site will be allocated to either intervention or control, in total three intervention and three control facilities divided over the three sites.
Care staff at the intervention facilities will participate in a 12-month education on how to integrate aspects of person-centredness, thriving and a caring environment into daily care practice. Participating staff will work together with their colleagues and members from the research group to create a reflective and creative learning environment that builds on and develops the staff members' clinical experience and skills, and combines it with theoretical and research-based knowledge.
At the control facilities, care staff will participate in a 2-hour lecture on the theoretical and philosophical foundations of person-centredness, thriving and a caring environment, and then continue with practice without further involvement from the research team.
Evaluation data will be collected by study specific questionnaires before the education starts, immediately after the education and at a 6-month follow-up. In addition, focus group interviews and individual interviews will be conducted with a selection of staff members and relatives at the intervention facilities to explore meaning and significance of the intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Behavioral: Person-centred carePerson-centred care |
| Control | No intervention | –Conventional care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- minimum 18 years of age
- living in the facility for >1 month by the time of data collection
- visiting the residential aged care facility on a regular basis (>1/month)
- working in the residential aged care facility on a temporary and or permanent basis (>1month contract)
- have been working >1 month in the residential aged care facility by the time of data collection.
Key exclusion criteria (3 listed)
- newly moved in to the facility
- visiting the facility more seldom than once a month
- working on a short-term contract
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Person-centred carePerson-centred and thriving promoting care | Behavioural | Intervention |
Primary outcome
Change in The Thriving of Older People Assessment Scale between baseline and follow-up
Time frame: Change from baseline thriving at 12 and 18 months
Data will be collected from residents at both intervention and control facilities by either self-rating or proxy-rating surveys at baseline and at 12 and 18 months follow-up
Change in relatives' satisfaction with care measured by the Pyramid questionnaire
Time frame: Change from baseline satisfaction at 12 and 18 months
Data will be collected from relatives at both intervention and control facilities by self-rating surveys at baseline and at 12 and 18 months follow-up
Change in staff's job satisfaction measured by the The Job satisfaction questionnaire
Time frame: Change from baseline job satisfaction at 12 and 18 months
Data will be collected from staff at both intervention and control facilities by self-rating surveys at baseline and at 12 and 18 months follow-up
4 secondary outcomes
Change in participants' experience of the caring environment measured by The Person-centred Climate Questionnaire
Time frame: Change from baseline experience at 12 and 18 months
Change in relatives' experienced satisfaction with visiting the nursing home and their relative, measured by Visual Analogue Scales of participants' subjective experiences of 12 statements, ranging from 0 (totally disagree) to 10 (totally agree).
Time frame: Change from baseline satisfaction at 12 and 18 months
Change in staff's stress of conscience measured by the Stress of Conscience questionnaire
Time frame: Change from baseline stress of conscience at 12 and 18 months
Change in staff's perception of the person-centredness of care measured by the Person-centred Care Assessment Tool
Time frame: Change from baseline perception at 12 and 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Derived from this study: PubMed 35485234Sjogren K, Bergland A, Kirkevold M, Lindkvist M, Lood Q, Sandman PO, Vassbo TK, Edvardsson D. Effects of a person-centred and thriving-promoting intervention on nursing home residents' experiences of thriving and person-centredness of the environment. Nurs Open. 2022 Jul;9(4):2117-2129. doi: 10.1002/nop2.1222. Epub 2022 Apr 29.
- Derived from this study: PubMed 33072363Vassbo TK, Bergland A, Kirkevold M, Lindkvist M, Lood Q, Sandman PO, Sjogren K, Edvardsson D. Effects of a person-centred and thriving-promoting intervention on nursing home staff job satisfaction: A multi-centre, non-equivalent controlled before-after study. Nurs Open. 2020 Jul 23;7(6):1787-1797. doi: 10.1002/nop2.565. eCollection 2020 Nov.
- Derived from this study: PubMed 32738880Lood Q, Sjogren K, Bergland A, Lindkvist M, Kirkevold M, Sandman PO, Edvardsson D. Effects of a staff education programme about person-centred care and promotion of thriving on relatives' satisfaction with quality of care in nursing homes: a multi-centre, non-equivalent controlled before-after trial. BMC Geriatr. 2020 Aug 1;20(1):268. doi: 10.1186/s12877-020-01677-7.
- Derived from this study: PubMed 28095791Edvardsson D, Sjogren K, Lood Q, Bergland A, Kirkevold M, Sandman PO. A person-centred and thriving-promoting intervention in nursing homes - study protocol for the U-Age nursing home multi-centre, non-equivalent controlled group before-after trial. BMC Geriatr. 2017 Jan 17;17(1):22. doi: 10.1186/s12877-016-0404-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Edvardsson, Professor principal investigator
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Person-centred care in people with Aging, run by Umeå University 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 11 Oct 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in The Thriving of Older People Assessment Scale between baseline and follow-up (time frame: Change from baseline thriving at 12 and 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02714452, which also lists 4 linked publications.
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 11 Oct 2018.