Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropscyhiatric Symptoms

Dementia Clinical Trial

— TIME  

Official title:

TIME - Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropscyhiatric Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02655003
• Other study ID #: 150333
• Status: Completed
• Phase: N/A
• First received: January 6, 2016
• Last updated: February 14, 2017
• Start date: January 7, 2016
• Est. completion date: July 2016

Study information

• Verified date: October 2016
• Source: Sykehuset Innlandet HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 (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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: July 2016
• Est. primary completion date: July 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Clinical Dementia Rating scale (CDR) 1 or higher.

2. Moderate to high grade of agitation defined by the NPI-NH agitation item as equal to or above six points.

3. Planned long-term stay in the nursing home, and a minimum of two weeks stay in the nursing home before inclusion.

Exclusion Criteria:

1.Terminal phase (life expectancy less than 4-6 weeks)

Related Conditions & MeSH terms

• Dementia

Intervention

Other:
• TIME

• Education-only intervention
The staff and physicians in the control nursing homes will receive a 2 hours education session about dementia and neuropsychiatric symptoms

Locations

Country	Name	City	State
Norway	Centre for Old Age Psychiatric Research, Sykehuset Innlandet Hospital Trust	Ottestad

Sponsors (1)

Lead Sponsor	Collaborator
Sykehuset Innlandet HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks and 12 weeks
Secondary	NPI-NH all separate items	The change from baseline of the remaining 11 items in the.Neuropsychiatric Inventory Nursing Home Version (NPI-NH).	8 weeks and 12 weeks
Secondary	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.	8 weeks and 12 weeks
Secondary	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.	8 weeks and 12 weeks
Secondary	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.	8 weeks and 12 weeks
Secondary	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	8 weeks and 12 weeks
Secondary	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.	8 weeks and 12 weeks
Secondary	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.	8 weeks and 12 weeks
Secondary	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.	8 weeks and 12 weeks
Secondary	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.	8 weeks and 12 weeks
Secondary	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.	8 weeks and 12 weeks
Secondary	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.	8 weeks and 12 weeks
Secondary	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)	8 weeks and 12 weeks