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Completed

NCT Number: NCT02655003

Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropscyhiatric Symptoms

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.

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Key information

Conditions

Dementia Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Old Age Psychiatric Research, Sykehuset Innlandet Hospital Trust

Ottestad, 2312, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical Dementia Rating scale (CDR) 1 or higher.
  • Moderate to high grade of agitation defined by the NPI-NH agitation item as equal to or above six points.
  • 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)

Treatment and study plan

TIME

Other

Other names: Targeted Interdisciplinary Model for Evaluation and treatment of neuropsychiatric symptoms

Education-only intervention

Other

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

Primary outcomes

  1. NPI-NH agitation/aggression

    Time frame: 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 outcomes

  1. NPI-NH all separate items

    Time frame: 8 weeks and 12 weeks

    The change from baseline of the remaining 11 items in the.Neuropsychiatric Inventory Nursing Home Version (NPI-NH).

  2. NPI-NH sub syndrome agitation

    Time frame: 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.

  3. NPI-NH sub syndrome affective symptoms

    Time frame: 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.

  4. NPI-NH sub syndrome psychosis

    Time frame: 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.

  5. NPI-10 NH sum score

    Time frame: 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

  6. The NPI-NH caregiver occupational disruptiveness score

    Time frame: 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.

  7. CMAI

    Time frame: 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.

  8. Lawton and Brody ADL scale

    Time frame: 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.

  9. The Cornell scale for depression in dementia CSDD

    Time frame: 8 weeks and 12 weeks

    The change from baseline in The Cornell scale for depression which measures the frequency of symptoms of depression.

  10. Drug usage

    Time frame: 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.

  11. Quality of life measured by the scale QUALID

    Time frame: 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.

  12. General medical health using the General Medical Health Rating scale

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Sykehuset Innlandet HF

Other

Registry information

Official study title

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

Acronym: TIME

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 13, 2016
Registry last updated
Feb 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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