An interventional study of TIME and Education-only intervention in Dementia, sponsored by Sykehuset Innlandet HF. Completed at 1 site in Norway. Per ClinicalTrials.gov, last updated 2017-02-15.
Sponsored by Sykehuset Innlandet HF · Not applicable, Interventional, and Treatment
Almost all people who suffer from dementia experience neuropsychiatric symptoms (NPS) in the course of the disease. TIME (Targeted Interdisciplinary Model for Evaluation and treatment of neuropsychiatric symptoms) is a multicomponent intervention based on the theoretical framework of cognitive behavioral therapy (CBT). The TIME trial is designed to assess the effects of TIME on NPS in nursing homes patients with dementia and the implementation process at staff and organization level.
TIME (Targeted Interdisciplinary Model for Evaluation and treatment of neuropsychiatric symptoms) is a multicomponent intervention based on the theoretical framework of cognitive behavioral therapy (CBT).The TIME trial includes a three months cluster randomized trial in 36 nursing homes with 164 participants with dementia and a high level of agitation. Each nursing home defines a cluster and will be randomized to receive either the intervention with TIME or a brief two hours education-only intervention about dementia and NPS for the control group. TIME consists of a manual based multicomponent program which includes a rigorous assessment, the treatment, and the evaluation of neuropsychiatrc symptoms (NPS). The staff, physicians and nursing home managers receive a one-day education. Three nurses from each unit will receive further education including practical and theoretical training for three hours. Measurements at patient level are taken at baseline prior to randomization and at eight and twelve weeks. The primary outcome measure is agitation. Mixed methods will be used to follow, measure and explore the implementation process and the effect at individual staff level and at organization level.
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's enrollment of 229 is above the median of 83 across 1,629 interventional studies indexed under Dementia.
Browse Dementia studies →Sykehuset Innlandet HF is the lead sponsor of 50 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
1.Terminal phase (life expectancy less than 4-6 weeks)
TIME consists of a manual based multicomponent program which includes a rigorous assessment, the treatment, and the evaluation of NPS. The staff, physicians and nursing home managers in the intervention nursing homes will receive a one-day education program. Three nurses from each unit will receive further education including practical and theoretical training for three hours.
Other: TIME
A brief two hours education-only intervention about dementia and NPS will be given to the staff in for the control nursing homes (CNH). The staff and physicians in the control nursing homes continue practice as usual.
Other: Education-only intervention
Also known as: Targeted Interdisciplinary Model for Evaluation and treatment of neuropsychiatric symptoms
The staff and physicians in the control nursing homes will receive a 2 hours education session about dementia and neuropsychiatric symptoms
NPI-NH agitation/aggression
The primary outcome measure is change from baseline of agitation and aggression as defined by the Neuropsychiatric Inventory Nursing Home Version (NPI-NH) item agitation/aggression.
Time frame: 8 weeks and 12 weeks
NPI-NH all separate items
The change from baseline of the remaining 11 items in the.Neuropsychiatric Inventory Nursing Home Version (NPI-NH).
Time frame: 8 weeks and 12 weeks
NPI-NH sub syndrome agitation
The change from baseline of the NPI-NH sub syndrome agitation is defined as the sum of the items agitation/aggression, irritability, and disinhibition in the NPI-NH.
Time frame: 8 weeks and 12 weeks
NPI-NH sub syndrome affective symptoms
The change from baseline of the NPI-NH sub syndrome affective symptoms is defined as the sum of the items depression and anxiety in the in the NPI-NH.
Time frame: 8 weeks and 12 weeks
NPI-NH sub syndrome psychosis
The change from baseline of the NPI-NH sub syndrome psychosis is defined as the sum of the items hallucinations and delusions items in the in the NPI-NH.
Time frame: 8 weeks and 12 weeks
NPI-10 NH sum score
The change from baseline of the NPI-10 NH sum score is the sum of the first ten items in the Neuropsychiatrc Inventory Nursing Homes version
Time frame: 8 weeks and 12 weeks
The NPI-NH caregiver occupational disruptiveness score
In the Neuropsychiatric Inventory Nursing Home Version (NPI-NH) the caregiver must rate how disruptive they find each behavior or symptom on a five point scale. The outcome is the change from baseline.
Time frame: 8 weeks and 12 weeks
CMAI
The change from baseline in the Cohen-Mansfield Agitation Inventory (CMAI) within its 29 different types of agitation and the frequency at which they occur.
Time frame: 8 weeks and 12 weeks
Lawton and Brody ADL scale
The change from baseline in the The Lawton and Brody ADL scale which describes 6 domains of activity of daily living with a score from 1 to 5 where 1 means no need for help and 5 means significant need for assistance.
Time frame: 8 weeks and 12 weeks
The Cornell scale for depression in dementia CSDD
The change from baseline in The Cornell scale for depression which measures the frequency of symptoms of depression.
Time frame: 8 weeks and 12 weeks
Drug usage
The change in drug dosage from baseline: that is the use of psychotropic and analgesic medication both as given regularly and on demand. This will be assessed using a questionnaire.
Time frame: 8 weeks and 12 weeks
Quality of life measured by the scale QUALID
The change from baseline in quality of life which will be assessed by the scale QUALID: Quality of life in late-stage dementia scale disease.
Time frame: 8 weeks and 12 weeks
General medical health using the General Medical Health Rating scale
The change from baseline in general medical health will be assessed by using the General Medical Health Rating scale (GMHR)
Time frame: 8 weeks and 12 weeks
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Sykehuset Innlandet HF