Ignite Creation Date:
2024-05-06 @ 8:03 AM
Last Modification Date:
2024-10-26 @ 11:55 AM
Study NCT ID:
NCT02655003
Status:
COMPLETED
Last Update Posted:
2017-02-15
First Post:
2016-01-06
Brief Title:
Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropscyhiatric Symptoms
Sponsor:
Sykehuset Innlandet HF
Organization:
Sykehuset Innlandet HF
Study Overview
Official Title:
TIME - Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropscyhiatric Symptoms
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TIME
Brief Summary:
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
Detailed Description:
TIME Targeted Interdisciplinary Model for Evaluation and treatment of neuropsychiatric symptoms is a multicomponent intervention based on the theoretical framework of cognitive behavioral therapy CBTThe 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None