Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropscyhiatric Symptoms (TIME)

Sykehuset Innlandet HF

Status: Completed

Conditions: Dementia

Treatments: Other: Education-only intervention; Other: TIME

Study type: Interventional

Funder types: Other

Identifiers

NCT02655003

150333

Details and patient eligibility

About

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.

Full 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.

Enrollment: 229 patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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229 participants in 2 patient groups

INH (Intervention Nursing Homes)

Experimental group

Description:

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.

Treatment:

Other: TIME

CNH (Control Nursing Homes)

Active Comparator group

Description:

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.

Treatment:

Other: Education-only intervention