DementiaTREANCT00820859
Treatment Routes for Exploring Agitation
A study testing TREA (Treatment Routes for Exploring Agitation) in people with Dementia and Behavior Problems, run by National Institute on Aging (NIA) at 1 site in United States.
Trial summary
The purpose of this study is to examine the efficacy of non-pharmacological ways to treat agitated behaviors in nursing home residents with dementia. The hypothesis is that non-pharmacological interventions will be more effective than placebo in decreasing such behaviors. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dementia, Behavior Problems
- What is being tested?
- TREA (Treatment Routes for Exploring Agitation)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 60 or older
- Diagnosis of dementia derived from the resident's medical chart at the facility or from an attending physician, as based on DSM-IV criteria and the Report of the NINCDS-ADRDA
- Resident of the facility for at least three weeks so that nursing staff members know the resident well enough to accurately assess him or her
- Identified by nursing staff to exhibit either verbal agitation or physical non-aggressive agitation at least several times a day
Who cannot join
- Lifelong diagnosis of schizophrenia
- Bipolar disorder diagnosed prior to onset of dementia
- Diagnosis of premorbid mental retardation
- Judged by direct-care nursing staff to have a life expectancy of less than 3 months
- Expected to leave the nursing home (either to enter the hospital or to go home) within the next 4 months
- Agitation manifested less than 6 times a day
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Research Institute on Aging
Rockville, Maryland, 20814
Jiska Cohen-Mansfield, PhD, ABPP, 301-770-8453, cohen-mansfield@hebrew-home.org
Marcia Marx, PhD, 301-770-8451, marx@hebrew-home.org
About this study
Official title: Treatment of Agitation in the Nursing Home
The purpose of this study is to examine the efficacy of non-pharmacological ways to treat agitated behaviors in nursing home residents with dementia. The hypothesis is that non-pharmacological interventions will be more effective than placebo in decreasing such behaviors.
Read the detailed description
Clinicians often refer to elderly persons under their care as "agitated." However, agitation is not a diagnosis, but rather, a descriptive term pertaining to a group of behavioral signs and symptoms, defined as socially inappropriate verbal, vocal, or motor (physical) activity that is not judged by an outside observer to result directly from the needs or confusion of the agitated individual. While the literature reports positive effects of non-pharmacological interventions, most studies tend to be based on small samples and do not yield statistically significant results. This study examines the impact of non-pharmacologic interventions tailored through an algorithm labeled TREA (Treatment Routes for Exploring Agitation) using a large, well-controlled, systematic research design.
TREA is an objective, systematic method for developing individualized non-pharmacological treatment plans based on an analysis of the agitated person's unmet needs, past and current preferences, past role-identity, cognitive, mobility, and sensory abilities/limitations, and possible causes for particular agitated behaviors. The methodology calls for ascertaining the type of agitated behavior and the most likely etiology, and then matching the intervention to the etiology and to the participant's characteristics.
The protocol involves the following steps:
- Baseline assessment - using standardized assessments (e.g., MMSE, ABMI, CMAI, Self-identity in dementia), collecting background demographic and medical information as well as systematic observations of the agitated resident
- Intervention exploration - after analyzing potential unmet needs as well as preferences, abilities and identities of each participant, investigators develop a list of potentially successful interventions, examining the effectiveness of a wide range of interventions, from family videos to manipulatives (e.g., puzzles, a tool kit)
- Intervention (treatment) phase - Interventions are systematically provided during the hours of highest agitation (determined at baseline) and observations are conducted at the same time. The treatment phase lasts for 10 days. The placebo control group includes a presentation to staff members as to how to intervene with behavior problems and similar observations of residents.
- Follow-up phase includes repeated assessments without interventions.
- Conditions
- Dementia, Behavior Problems
- Being tested
- TREA (Treatment Routes for Exploring Agitation), Placebo Control Group
- Keywords
- Cognition disorder, nursing home residents, agitation, behavior disorder
- Medical subject headings
- Dementia, Mental Disorders, Cognition Disorders, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TREA (Treatment Routes for Exploring Agitation)Behavioural
Individualized non-pharmacological treatment plan for agitation
Placebo Control GroupBehavioural
A presentation on the treatment of behavior problems in dementia given to the staff caregivers of the comparison group
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Behavioral: TREA (Treatment Routes for Exploring Agitation) |
| 2 | Active comparator | Not described Receives: Behavioral: Placebo Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agitation Behavior Mapping Instrument (ABMI)
Measured: 10 days of intervention vs. 10 days of baseline
Secondary outcomes (1)
affect/mood measured by Lawton's behavior stream assessment
Measured: 10 days of intervention vs. 10 days of baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2009 (estimated)
- Study startJun 2006
- Primary completionJun 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Jiska Cohen-Mansfield, PhD, Principal investigator, Research Institute on Aging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00820859
- Sponsor's protocol ID
- IA0144
- Other IDs
- 5R01AG010172-11
- Acronym
- TREA
- Status last verified
- Jul 2009
- First submitted
- 8 Jan 2009
- Last updated
- 3 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Cohen-Mansfield J. Agitated behavior in persons with dementia: the relationship between type of behavior, its frequency, and its disruptiveness. J Psychiatr Res. 2008 Nov;43(1):64-9. doi: 10.1016/j.jpsychires.2008.02.003. Epub 2008 Apr 3.
PubMed 18394647Cohen-Mansfield J, Libin A, Marx MS. Nonpharmacological treatment of agitation: a controlled trial of systematic individualized intervention. J Gerontol A Biol Sci Med Sci. 2007 Aug;62(8):908-16. doi: 10.1093/gerona/62.8.908.
PubMed 17702884Cohen-Mansfield J, Marx MS, Rosenthal AS. A description of agitation in a nursing home. J Gerontol. 1989 May;44(3):M77-84. doi: 10.1093/geronj/44.3.m77.
PubMed 2715584Cohen-Mansfield J, Thein K, Marx MS, Dakheel-Ali M, Freedman L. Efficacy of nonpharmacologic interventions for agitation in advanced dementia: a randomized, placebo-controlled trial. J Clin Psychiatry. 2012 Sep;73(9):1255-61. doi: 10.4088/JCP.12m07918.
PubMed 23059151
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Agitation in the Nursing Home
- ClinicalTrials.gov ID
- NCT00820859
- Acronym / sponsor ID
- TREA / IA0144
- Conditions
- Dementia, Behavior Problems
- Keywords
- Cognition disorder, nursing home residents, agitation, behavior disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- Jun 2006
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 12 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the efficacy of non-pharmacological ways to treat agitated behaviors in nursing home residents with dementia. The hypothesis is that non-pharmacological interventions will be more effective than placebo in decreasing such behaviors.
Detailed description
Clinicians often refer to elderly persons under their care as "agitated." However, agitation is not a diagnosis, but rather, a descriptive term pertaining to a group of behavioral signs and symptoms, defined as socially inappropriate verbal, vocal, or motor (physical) activity that is not judged by an outside observer to result directly from the needs or confusion of the agitated individual. While the literature reports positive effects of non-pharmacological interventions, most studies tend to be based on small samples and do not yield statistically significant results. This study examines the impact of non-pharmacologic interventions tailored through an algorithm labeled TREA (Treatment Routes for Exploring Agitation) using a large, well-controlled, systematic research design.
TREA is an objective, systematic method for developing individualized non-pharmacological treatment plans based on an analysis of the agitated person's unmet needs, past and current preferences, past role-identity, cognitive, mobility, and sensory abilities/limitations, and possible causes for particular agitated behaviors. The methodology calls for ascertaining the type of agitated behavior and the most likely etiology, and then matching the intervention to the etiology and to the participant's characteristics.
The protocol involves the following steps:
- Baseline assessment - using standardized assessments (e.g., MMSE, ABMI, CMAI, Self-identity in dementia), collecting background demographic and medical information as well as systematic observations of the agitated resident
- Intervention exploration - after analyzing potential unmet needs as well as preferences, abilities and identities of each participant, investigators develop a list of potentially successful interventions, examining the effectiveness of a wide range of interventions, from family videos to manipulatives (e.g., puzzles, a tool kit)
- Intervention (treatment) phase - Interventions are systematically provided during the hours of highest agitation (determined at baseline) and observations are conducted at the same time. The treatment phase lasts for 10 days. The placebo control group includes a presentation to staff members as to how to intervene with behavior problems and similar observations of residents.
- Follow-up phase includes repeated assessments without interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: TREA (Treatment Routes for Exploring Agitation) |
| 2 | Active comparator | Behavioral: Placebo Control Group |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 60 or older
- Diagnosis of dementia derived from the resident's medical chart at the facility or from an attending physician, as based on DSM-IV criteria and the Report of the NINCDS-ADRDA
- Resident of the facility for at least three weeks so that nursing staff members know the resident well enough to accurately assess him or her
- Identified by nursing staff to exhibit either verbal agitation or physical non-aggressive agitation at least several times a day
Key exclusion criteria (6 listed)
- Lifelong diagnosis of schizophrenia
- Bipolar disorder diagnosed prior to onset of dementia
- Diagnosis of premorbid mental retardation
- Judged by direct-care nursing staff to have a life expectancy of less than 3 months
- Expected to leave the nursing home (either to enter the hospital or to go home) within the next 4 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TREA (Treatment Routes for Exploring Agitation)Individualized non-pharmacological treatment plan for agitation | Behavioural | 1 |
| Placebo Control GroupA presentation on the treatment of behavior problems in dementia given to the staff caregivers of the comparison group | Behavioural | 2 |
Primary outcome
Agitation Behavior Mapping Instrument (ABMI)
Time frame: 10 days of intervention vs. 10 days of baseline
1 secondary outcome
affect/mood measured by Lawton's behavior stream assessment
Time frame: 10 days of intervention vs. 10 days of baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2009.
- Background: PubMed 18394647Cohen-Mansfield J. Agitated behavior in persons with dementia: the relationship between type of behavior, its frequency, and its disruptiveness. J Psychiatr Res. 2008 Nov;43(1):64-9. doi: 10.1016/j.jpsychires.2008.02.003. Epub 2008 Apr 3.
- Background: PubMed 17702884Cohen-Mansfield J, Libin A, Marx MS. Nonpharmacological treatment of agitation: a controlled trial of systematic individualized intervention. J Gerontol A Biol Sci Med Sci. 2007 Aug;62(8):908-16. doi: 10.1093/gerona/62.8.908.
- Background: PubMed 2715584Cohen-Mansfield J, Marx MS, Rosenthal AS. A description of agitation in a nursing home. J Gerontol. 1989 May;44(3):M77-84. doi: 10.1093/geronj/44.3.m77.
- Derived from this study: PubMed 23059151Cohen-Mansfield J, Thein K, Marx MS, Dakheel-Ali M, Freedman L. Efficacy of nonpharmacologic interventions for agitation in advanced dementia: a randomized, placebo-controlled trial. J Clin Psychiatry. 2012 Sep;73(9):1255-61. doi: 10.4088/JCP.12m07918.
- Research Institute on AgingLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiska Cohen-Mansfield, PhD principal investigator
Research Institute on Aging
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TREA (Treatment Routes for Exploring Agitation) in people with Dementia and Behavior Problems, run by National Institute on Aging (NIA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiska Cohen-Mansfield, PhD (301-770-8453, cohen-mansfield@hebrew-home.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agitation Behavior Mapping Instrument (ABMI) (time frame: 10 days of intervention vs. 10 days of baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00820859, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2009.