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

February 14, 2017 updated by: Sykehuset Innlandet HF

TIME - 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

229

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Ottestad, Norway, 2312
        • Centre for Old Age Psychiatric Research, Sykehuset Innlandet Hospital Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
8 weeks and 12 weeks
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.
8 weeks and 12 weeks
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.
8 weeks and 12 weeks
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.
8 weeks and 12 weeks
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
8 weeks and 12 weeks
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.
8 weeks and 12 weeks
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 weeks and 12 weeks
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.
8 weeks and 12 weeks
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.
8 weeks and 12 weeks
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.
8 weeks and 12 weeks
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.
8 weeks and 12 weeks
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)
8 weeks and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sykehuset Innlandet HF

Investigators

  • Principal Investigator: Sverre Bergh, PhD, +4745679393

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2016

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

January 6, 2016

First Submitted That Met QC Criteria

January 11, 2016

First Posted (Estimate)

January 13, 2016

Study Record Updates

Last Update Posted (Actual)

February 15, 2017

Last Update Submitted That Met QC Criteria

February 14, 2017

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 150333

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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