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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01217541
Other study ID # 50022
Secondary ID
Status Completed
Phase N/A
First received September 22, 2010
Last updated December 11, 2014
Start date September 2010
Est. completion date March 2012

Study information

Verified date December 2014
Source Sykehuset Innlandet HF
Contact n/a
Is FDA regulated No
Health authority Norway: Ethics Committee
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 700
Est. completion date March 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Intervention

Other:
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.
Control
A control group of nursing home units that do not get any form of active intervention

Locations

Country Name City State
Norway Lillehammer sykehjem Lillehammer Oppland

Sponsors (3)

Lead Sponsor Collaborator
Sykehuset Innlandet HF Helse Sor-Ost, Norwegian Department of Health and Social Affairs

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Kirkevold Ø, 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. — View Citation

Selbaek G, Kirkevold Ø, 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 12 months after baseline assessment No
Secondary 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 12 months after baseline assessment No
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