- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01217541
Collaboration Between Department of Old Age Psychiatry and Nursing Homes (SAM-AKS)
December 11, 2014 updated by: Sverre Bergh, Sykehuset Innlandet HF
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
700
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oppland
-
Lillehammer, Oppland, Norway
- Lillehammer sykehjem
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All patients at nursing home units
Exclusion Criteria:
- Patients that are in a final state and patients that have not been at the nursing home unit more than two weeks
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Education and supervision
Personnel in nursing home units get intervention in form of education and supervision
|
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 Names:
A control group of nursing home units that do not get any form of active intervention
Other Names:
|
No Intervention: Control
Only registering of patient and personnel data in the beginning and the end of the study without any form of intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 months after baseline assessment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neuropsychiatric Inventory - Nursing Home version, Cornell Scale of Depression in Dementia, Registration of Constraints (Kirkevold, 2004)
Time Frame: 12 months after baseline assessment
|
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
|
12 months after baseline assessment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Geir Selbæk, PhD, Sykehuset Innlandet HF
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Kirkevold 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
March 1, 2012
Study Completion (Actual)
March 1, 2012
Study Registration Dates
First Submitted
September 22, 2010
First Submitted That Met QC Criteria
October 7, 2010
First Posted (Estimate)
October 8, 2010
Study Record Updates
Last Update Posted (Estimate)
December 12, 2014
Last Update Submitted That Met QC Criteria
December 11, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 50022
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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