Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropscyhiatric Symptoms

Not Applicable

Completed

• Conditions: Dementia
• Interventions: Other: TIME; Other: Education-only intervention

• Registration Number: NCT02655003
• Lead Sponsor: Sykehuset Innlandet HF

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 (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.

Study Timeline

• Study First Submitted: 2016-01-06
• Study Start: 2016-01-07
• Study First Submitted QC: 2016-01-11
• Study First Posted: 2016-01-13
• Primary Completion: 2016-07-01
• Study Completion: 2016-07
• Status Verified: 2016-10
• Last Update Submitted: 2017-02-14
• Last Update Posted: 2017-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 229

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
INH (Intervention Nursing Homes)	TIME	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.
CNH (Control Nursing Homes)	Education-only intervention	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.

Primary Outcome Measures

Name	Time	Method
NPI-NH agitation/aggression	8 weeks and 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
The NPI-NH caregiver occupational disruptiveness score	8 weeks and 12 weeks	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.
CMAI	8 weeks and 12 weeks	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.
NPI-NH sub syndrome psychosis	8 weeks and 12 weeks	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.
Lawton and Brody ADL scale	8 weeks and 12 weeks	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.
Quality of life measured by the scale QUALID	8 weeks and 12 weeks	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.
General medical health using the General Medical Health Rating scale	8 weeks and 12 weeks	The change from baseline in general medical health will be assessed by using the General Medical Health Rating scale (GMHR)
NPI-NH all separate items	8 weeks and 12 weeks	The change from baseline of the remaining 11 items in the.Neuropsychiatric Inventory Nursing Home Version (NPI-NH).
NPI-NH sub syndrome agitation	8 weeks and 12 weeks	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.
NPI-NH sub syndrome affective symptoms	8 weeks and 12 weeks	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.
NPI-10 NH sum score	8 weeks and 12 weeks	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
The Cornell scale for depression in dementia CSDD	8 weeks and 12 weeks	The change from baseline in The Cornell scale for depression which measures the frequency of symptoms of depression.
Drug usage	8 weeks and 12 weeks	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.

Trial Locations

Locations (1)

Centre for Old Age Psychiatric Research, Sykehuset Innlandet Hospital Trust; 🇳🇴 Ottestad, Norway