Staff and Older Persons With Home Care ServiceNCT02846246
The Effects and Meaning of a Person-centred and Health-promoting Intervention in Home Care Services
A study testing Person-centred and health-promoting home care service and Care as usual in people with Staff and Older Persons With Home Care Service, run by Umeå University.
Trial summary
Current home care service are to a large extent task oriented with a limited focus on care recipient's involvement. Furthermore, studies have shown that low care recipients' involvement might decrease older people's quality of life. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Staff and Older Persons With Home Care Service
- What is being tested?
- Person-centred and health-promoting home care service and Care as usual
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Jun 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- persons 65 years or older
- living at home with granted HCS
- have at least two visits per month, and
- be Swedish speaking
- be defined by the care recipients as his/her family member, and
- Swedish speaking
Show all 9Show fewer
- have an employment for more than 6 month in the HCS district at baseline, be a contact staff and
- Swedish speaking
- Care recipients who apply for HCS in the district during the study period will be offered the intervention but not be included in the evaluation
Who cannot join
- No exclusion criteria
About this study
Official title: The Effects and Meaning of a Person-centred and Health-promoting Intervention in Home Care Services: Study Protocol of a Non-randomised Controlled Trial
Current home care service are to a large extent task oriented with a limited focus on care recipient's involvement. Furthermore, studies have shown that low care recipients' involvement might decrease older people's quality of life. Person-centred care focusing on involvement has improved the quality of life and the satisfaction with care for older people in health care and nursing homes but there is a lack of knowledge about the effects and meaning of a person-centred interventions in aged care at home. Present study describes the evaluation of a person-centred and health-promoting intervention.
Read the detailed description
This is a non-randomised controlled trial with a before-after approach. The investigators will include 270 home care recipients >65 years, 270 family members and 65 staff in intervention group and control group respectively. Participants will be recruited from a municipality in northern Sweden. The intervention involves letting the person and family together with contact nurse prioritise care content and make rearrangements to make sure the home care service maximises the potential to satisfy psychosocial, physical, and functional needs and increasing health. Outcome assessment will focus on; a) quality of life (primary outcomes), thriving and satisfaction with care for older people, b) caregiver strain, informal caregiving engagement and satisfaction with care for relatives, c) job satisfaction and stress for care staff. Evaluation will be performed by questionnaires and interviews.
Person-centred home care services have the potential to improve the recurrently reported sub-standard experiences of home care services and the study result will hopefully lead the way in establish a person-centred and health-promoting model in aged care and living conditions for older people.
- Being tested
- Person-centred and health-promoting home care service, Care as usual
- Keywords
- aged care, health, home care services, person-centred care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Person-centred and health-promoting home care serviceOther
Firstly, staff will take part in an educational program on the content and operationalization of the central theoretical components person-centeredness and health exploratory conversation. Secondly, staff will participate in supervised skill training in how to accomplish person-centered and health exploratory conversation. Thirdly, the staff will have a person-centred and health exploratory conversation with purpose to evaluate the extent to which current home care service practice meet the older person´s need and maintain or make rearrangement in provided care to maximise older people's health. Finally, staff will participate in clinical supervisory sessions with an aim to support and facilitate ongoing operationalization phase.
Care as usualOther
The control group will be offered a lecture about dementia based on staff wishes and a usual care paradigm will guide the control units, i.e. a continuation with practice as usual. Control units will receive the intervention protocol and study results at the end of the study.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The experimental group will be introduced to a person-centred care model that involves shared decision making where the person with home care service and family together with contact nurse prioritise care content and make rearrangements to make sure the provided home care service maximises health. Receives: Other: Person-centred and health-promoting home care service |
| Control | Sham comparator | A usual care paradigm will guide the control units, i.e. a continuation with practice as usual. Receives: Other: Care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Quality of Life assessed with the Nottingham Health Profile scale
The Nottingham Health Profile scale will be used to assess quality of life. Nottingham health profile includes 38 items in six dimensions: energy level, pain, emotional reaction, sleep, social isolation, and physical abilities. Each item is answered through Yes/No statements and range from best (0) to worst (100) possible score. The Nottingham Health Profile has been found to be sensitive for changes, valid and reliable.
Measured: Baseline, 12 and 24 month follow-up
Change of Quality of Life assessed with the EQ-5D
As a complement, the EQ-5D will also be used to assess quality of life. The EQ-5D consists of two parts, a health state description and a visual analogue scale. The health state description comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has five levels on a Likert-scale: none (0) to extreme (4). The visual analogue scale rates participants overall health between endpoints, worst imaginable health (0) and best imaginable health (100). EQ-5D has been found to be sensitive for changes and valid.
Measured: Baseline, 12 and 24 month follow-up
Secondary outcomes (2)
Change in thriving assessed with the Thriving of Older People Assessment Scale
Thriving will be assessed with The Thriving of Older People Assessment Scale which includes 32 items and consists of five sub-scales: resident attitude towards the place where they are living, quality of the care and care-givers, activities and peer relationships, opportunities to keep in touch with people and places of importance, and qualities in the physical environment. Each item has six answer alternatives on a Likert-scale ranging from No (1) to Yes, I agree completely (6). The Thriving of Older People Assessment Scale has been found to be valid and reliable.
Measured: baseline, 12 and 24 month follow-up
Change in satisfaction with home care service assessed with the Quality of Care from the Patients' Perspective
Satisfaction with home care service will be measured with The Quality of Care from the Patients' Perspective which includes 64 items and consists of four dimensions: medical-technical competence (11 items), physical-technical conditions (10 items), identity-oriented approach (30 items) and social-cultural atmosphere (13 items). Each item should be answered in two ways; perceived reality and subjective importance. Perceived reality range between Not applicable (1) to Fully agree (5) on a five level Likert-scale while the subjective importance range between Of very great importance (1) to of little importance (4). The Quality of Care from the Patients' Perspective has been found to be valid and reliable.
Measured: baseline, 12 and 24 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startSep 2015
- Primary completionMay 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Staff and Older Persons With Home Care ServiceStudies 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
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Edvardsson, Umeå University
- Investigators
- David Edvardsson, Professor, Principal investigator, Umea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02846246
- Sponsor's protocol ID
- 2016/04-31Ö
- Status last verified
- Jan 2024
- First submitted
- 12 Jul 2016
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lamas K, Bolenius K, Sandman PO, Lindkvist M, Edvardsson D. Effects of a person-centred and health-promoting intervention in home care services- a non-randomized controlled trial. BMC Geriatr. 2021 Dec 18;21(1):720. doi: 10.1186/s12877-021-02661-5.
PubMed 34922494Bolenius K, Lamas K, Sandman PO, Lindkvist M, Edvardsson D. Perceptions of self-determination and quality of life among Swedish home care recipients - a cross-sectional study. BMC Geriatr. 2019 May 24;19(1):142. doi: 10.1186/s12877-019-1145-8.
PubMed 31126243Bolenius K, Lamas K, Sandman PO, Edvardsson D. Effects and meanings of a person-centred and health-promoting intervention in home care services - a study protocol of a non-randomised controlled trial. BMC Geriatr. 2017 Feb 16;17(1):57. doi: 10.1186/s12877-017-0445-0.
PubMed 28209122
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects and Meaning of a Person-centred and Health-promoting Intervention in Home Care Services: Study Protocol of a Non-randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02846246
- Acronym / sponsor ID
- 2016/04-31Ö
- Keywords
- aged care, health, home care services, person-centred care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 27 Jul 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.
Current home care service are to a large extent task oriented with a limited focus on care recipient's involvement. Furthermore, studies have shown that low care recipients' involvement might decrease older people's quality of life. Person-centred care focusing on involvement has improved the quality of life and the satisfaction with care for older people in health care and nursing homes but there is a lack of knowledge about the effects and meaning of a person-centred interventions in aged care at home. Present study describes the evaluation of a person-centred and health-promoting intervention.
Detailed description
This is a non-randomised controlled trial with a before-after approach. The investigators will include 270 home care recipients >65 years, 270 family members and 65 staff in intervention group and control group respectively. Participants will be recruited from a municipality in northern Sweden. The intervention involves letting the person and family together with contact nurse prioritise care content and make rearrangements to make sure the home care service maximises the potential to satisfy psychosocial, physical, and functional needs and increasing health. Outcome assessment will focus on; a) quality of life (primary outcomes), thriving and satisfaction with care for older people, b) caregiver strain, informal caregiving engagement and satisfaction with care for relatives, c) job satisfaction and stress for care staff. Evaluation will be performed by questionnaires and interviews.
Person-centred home care services have the potential to improve the recurrently reported sub-standard experiences of home care services and the study result will hopefully lead the way in establish a person-centred and health-promoting model in aged care and living conditions for older people.
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 | Experimental | Other: Person-centred and health-promoting home care serviceThe experimental group will be introduced to a person-centred care model that involves shared decision making where the person with home care service and family together with contact nurse prioritise care content and make rearrangements to make sure the provided home care service maximises health. |
| Control | Sham comparator | Other: Care as usualA usual care paradigm will guide the control units, i.e. a continuation with practice as usual. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- persons 65 years or older
- living at home with granted HCS
- have at least two visits per month, and
- be Swedish speaking
- be defined by the care recipients as his/her family member, and
Key exclusion criteria (1 listed)
- No exclusion criteria
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 and health-promoting home care serviceFirstly, staff will take part in an educational program on the content and operationalization of the central theoretical components person-centeredness and health exploratory conversation. Secondly, staff will participate in supervised skill training in how to accomplish person-centered and health exploratory conversation. Thirdly, the staff will have a person-centred and health exploratory conversation with purpose to evaluate the extent to which current home care service practice meet the older person´s need and maintain or make rearrangement in provided care to maximise older people's health. Finally, staff will participate in clinical supervisory sessions with an aim to support and facilitate ongoing operationalization phase. | Other | Intervention |
| Care as usualThe control group will be offered a lecture about dementia based on staff wishes and a usual care paradigm will guide the control units, i.e. a continuation with practice as usual. Control units will receive the intervention protocol and study results at the end of the study. | Other | Control |
Primary outcome
Change of Quality of Life assessed with the Nottingham Health Profile scale
Time frame: Baseline, 12 and 24 month follow-up
The Nottingham Health Profile scale will be used to assess quality of life. Nottingham health profile includes 38 items in six dimensions: energy level, pain, emotional reaction, sleep, social isolation, and physical abilities. Each item is answered through Yes/No statements and range from best (0) to worst (100) possible score. The Nottingham Health Profile has been found to be sensitive for changes, valid and reliable.
Change of Quality of Life assessed with the EQ-5D
Time frame: Baseline, 12 and 24 month follow-up
As a complement, the EQ-5D will also be used to assess quality of life. The EQ-5D consists of two parts, a health state description and a visual analogue scale. The health state description comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has five levels on a Likert-scale: none (0) to extreme (4). The visual analogue scale rates participants overall health between endpoints, worst imaginable health (0) and best imaginable health (100). EQ-5D has been found to be sensitive for changes and valid.
2 secondary outcomes
Change in thriving assessed with the Thriving of Older People Assessment Scale
Time frame: baseline, 12 and 24 month follow-up
Change in satisfaction with home care service assessed with the Quality of Care from the Patients' Perspective
Time frame: baseline, 12 and 24 month follow-up
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 19 Jan 2024.
- Derived from this study: PubMed 34922494Lamas K, Bolenius K, Sandman PO, Lindkvist M, Edvardsson D. Effects of a person-centred and health-promoting intervention in home care services- a non-randomized controlled trial. BMC Geriatr. 2021 Dec 18;21(1):720. doi: 10.1186/s12877-021-02661-5.
- Derived from this study: PubMed 31126243Bolenius K, Lamas K, Sandman PO, Lindkvist M, Edvardsson D. Perceptions of self-determination and quality of life among Swedish home care recipients - a cross-sectional study. BMC Geriatr. 2019 May 24;19(1):142. doi: 10.1186/s12877-019-1145-8.
- Derived from this study: PubMed 28209122Bolenius K, Lamas K, Sandman PO, Edvardsson D. Effects and meanings of a person-centred and health-promoting intervention in home care services - a study protocol of a non-randomised controlled trial. BMC Geriatr. 2017 Feb 16;17(1):57. doi: 10.1186/s12877-017-0445-0.
- Individual participant dataSharing planned: No
Related trials for Staff and Older Persons With Home Care Service
Not yet recruitingObservational study
Elderly Care in Transition - the Older Persons' and the Staff's Perspective
Older People With Home Care, Staff Working With Older People in Home Care
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
Umea University
Questions about this trial
What is this clinical trial studying?
A study testing Person-centred and health-promoting home care service and Care as usual in people with Staff and Older Persons With Home Care Service, run by Umeå University.
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 9 inclusion and 1 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 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 of Quality of Life assessed with the Nottingham Health Profile scale (time frame: Baseline, 12 and 24 month follow-up). 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?
On the ClinicalTrials.gov record for NCT02846246, which also lists 3 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 19 Jan 2024.