DementiaSAM-AKSNCT01217541
Collaboration Between Department of Old Age Psychiatry and Nursing Homes
A study testing Education and Supervision in people with Dementia and Alzheimer's Disease, run by Sykehuset Innlandet HF at 1 site in Norway.
Trial summary
Dementia is a serious health problem showing an increasing prevalence rate with increasing age. In Norway, about 80% of nursing home patients have dementia. The mean age of nursing home residents in Norway is around 84 years. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia, Alzheimer's Disease, Behavioral Symptoms
- What is being tested?
- Education and Supervision
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2010to Mar 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients at nursing home units
Who cannot join
- Patients that are in a final state and patients that have not been at the nursing home unit more than two weeks
Trial locations and contacts
1 site in 1 country.
About this study
Dementia is a serious health problem showing an increasing prevalence rate with increasing age. In Norway, about 80% of nursing home patients have dementia. The mean age of nursing home residents in Norway is around 84 years. Disruptive and agitated behaviour affect 30-50% of all individuals with dementia at some point in the course of the illness. In addition, they have a combination of physical and psychological diseases which necessitates a close collaboration between different specialities in medicine and Old Age psychiatry. In collaboration with the communalities, our Old Age psychiatry services want to provide a new approach to this challenge and validate it on patient and personnel level.
- Conditions
- Dementia, Alzheimer's Disease, Behavioral Symptoms, Agitation
- Being tested
- Education and Supervision, Control
- Keywords
- Dementia, BPSD, Quality of Life, Person-centred care, Job satisfaction, Nursing home, Primary care
- Medical subject headings
- Dementia, Alzheimer Disease, Behavioral Symptoms, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education and SupervisionOther
Also called Departments in NHs that do not get any intervention.
Implementation of Scales in the care of patients with dementia in nursing home units with focus on person-centred care. Supervision of caregivers on a regular basis.
ControlOther
Also called Education, Supervision
A control group of nursing home units that do not get any form of active intervention
| Study group | Role | What they receive |
|---|---|---|
| Education and supervision | Other | Personnel in nursing home units get intervention in form of education and supervision Receives: Other: Education and Supervision; Other: Control |
| Control | No intervention | Only registering of patient and personnel data in the beginning and the end of the study without any form of intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life in Severe Dementia (QUALID), Person-Centred Care Assessment Tool (P-CAT, 2010)
Evaluate a new model of collaboration between a specialized department of Old Age Psychiatry and nursing home units to optimize patient care and job satisfaction of the caregivers.
Measured: 12 months after baseline assessment
Secondary outcomes (1)
Neuropsychiatric Inventory - Nursing Home version, Cornell Scale of Depression in Dementia, Registration of Constraints (Kirkevold, 2004)
In addition, we want to carry out a qualitative evaluation of the process of implementation of new scales and the effect of supervision on personnel and patients
Measured: 12 months after baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset Innlandet HF
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Sor-Ost, Norwegian Department of Health and Social Affairs
- Responsible party
- Principal investigator, Sverre Bergh, Sykehuset Innlandet HF
- Investigators
- Geir Selbæk, PhD, Principal investigator, Sykehuset Innlandet HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01217541
- Sponsor's protocol ID
- 50022
- Acronym
- SAM-AKS
- Status last verified
- Dec 2014
- First submitted
- 22 Sep 2010
- Last updated
- 12 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Selbaek G, Kirkevold O, Engedal K. Psychiatric and behavioural symptoms and the use of psychotropic medication in Special Care Units and Regular Units in Norwegian nursing homes. Scand J Caring Sci. 2008 Dec;22(4):568-73. doi: 10.1111/j.1471-6712.2007.00576.x. Epub 2008 Sep 16.
PubMed 18801019Kirkevold O, Laake K, Engedal K. Use of constraints and surveillance in Norwegian wards for the elderly. Int J Geriatr Psychiatry. 2003 Jun;18(6):491-7. doi: 10.1002/gps.883.
PubMed 12789669
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaboration Between Department of Old Age Psychiatry and Nursing Homes
- ClinicalTrials.gov ID
- NCT01217541
- Acronym / sponsor ID
- SAM-AKS / 50022
- Conditions
- Dementia, Alzheimer's Disease, Behavioral Symptoms, Agitation
- Keywords
- Dementia, BPSD, Quality of Life, Person-centred care, Job satisfaction, Nursing home, Primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Sykehuset Innlandet HFUniversity, hospital or other
- Collaborators
- Helse Sor-Ost, Norwegian Department of Health and Social Affairs
- Study start
- Sep 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 8 Oct 2010 (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.
Dementia is a serious health problem showing an increasing prevalence rate with increasing age. In Norway, about 80% of nursing home patients have dementia. The mean age of nursing home residents in Norway is around 84 years. Disruptive and agitated behaviour affect 30-50% of all individuals with dementia at some point in the course of the illness. In addition, they have a combination of physical and psychological diseases which necessitates a close collaboration between different specialities in medicine and Old Age psychiatry. In collaboration with the communalities, our Old Age psychiatry services want to provide a new approach to this challenge and validate it on patient and personnel level.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education and supervision | Other | Other: Education and Supervision, Other: ControlPersonnel in nursing home units get intervention in form of education and supervision |
| Control | No intervention | –Only registering of patient and personnel data in the beginning and the end of the study without any form of intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients at nursing home units
Key exclusion criteria (1 listed)
- Patients that are in a final state and patients that have not been at the nursing home unit more than two weeks
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 |
|---|---|---|
| Education and SupervisionAlso: Departments in NHs that do not get any intervention.Implementation of Scales in the care of patients with dementia in nursing home units with focus on person-centred care. Supervision of caregivers on a regular basis. | Other | Education and supervision |
| ControlAlso: Education, SupervisionA control group of nursing home units that do not get any form of active intervention | Other | Education and supervision |
Primary outcome
Quality of Life in Severe Dementia (QUALID), Person-Centred Care Assessment Tool (P-CAT, 2010)
Time frame: 12 months after baseline assessment
Evaluate a new model of collaboration between a specialized department of Old Age Psychiatry and nursing home units to optimize patient care and job satisfaction of the caregivers.
1 secondary outcome
Neuropsychiatric Inventory - Nursing Home version, Cornell Scale of Depression in Dementia, Registration of Constraints (Kirkevold, 2004)
Time frame: 12 months after baseline assessment
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 12 Dec 2014.
- Background: PubMed 18801019Selbaek G, Kirkevold O, Engedal K. Psychiatric and behavioural symptoms and the use of psychotropic medication in Special Care Units and Regular Units in Norwegian nursing homes. Scand J Caring Sci. 2008 Dec;22(4):568-73. doi: 10.1111/j.1471-6712.2007.00576.x. Epub 2008 Sep 16.
- Background: PubMed 12789669Kirkevold O, Laake K, Engedal K. Use of constraints and surveillance in Norwegian wards for the elderly. Int J Geriatr Psychiatry. 2003 Jun;18(6):491-7. doi: 10.1002/gps.883.
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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.
Geir Selbæk, PhD principal investigator
Sykehuset Innlandet HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and Supervision in people with Dementia and Alzheimer's Disease, run by Sykehuset Innlandet HF at 1 site in Norway.
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 1 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 12 Dec 2014. 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 Norway. 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?
Quality of Life in Severe Dementia (QUALID), Person-Centred Care Assessment Tool (P-CAT, 2010) (time frame: 12 months after baseline assessment). 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 NCT01217541, which also lists 2 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 12 Dec 2014.