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Trial record 2 of 117025 for:    TIME

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

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ClinicalTrials.gov Identifier: NCT02655003
Recruitment Status : Completed
First Posted : January 13, 2016
Last Update Posted : February 15, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Dementia Other: TIME Other: Education-only intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 229 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: TIME - Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropscyhiatric Symptoms
Actual Study Start Date : January 7, 2016
Actual Primary Completion Date : July 1, 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: INH (Intervention Nursing Homes)
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.
Other: TIME
Other Name: Targeted Interdisciplinary Model for Evaluation and treatment of neuropsychiatric symptoms

Active Comparator: CNH (Control Nursing Homes)
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.
Other: Education-only intervention
The staff and physicians in the control nursing homes will receive a 2 hours education session about dementia and neuropsychiatric symptoms




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02655003


Locations
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Norway
Centre for Old Age Psychiatric Research, Sykehuset Innlandet Hospital Trust
Ottestad, Norway, 2312
Sponsors and Collaborators
Sykehuset Innlandet HF
Investigators
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Principal Investigator: Sverre Bergh, PhD +4745679393

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sykehuset Innlandet HF
ClinicalTrials.gov Identifier: NCT02655003     History of Changes
Other Study ID Numbers: 150333
First Posted: January 13, 2016    Key Record Dates
Last Update Posted: February 15, 2017
Last Verified: October 2016
Keywords provided by Sykehuset Innlandet HF:
behavioral symptoms
psychological symptoms
dementia
neuropsychiatric symptoms
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders