Preventing Aggression in Veterans With Dementia

NCT01325714 | Completed Phase 3 Results

• 1 other identifier: IIR 09-351
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

Brief Summary

This study tests whether education about memory and pain might help to prevent aggression in persons with dementia who have pain. The overall goal of this intervention is to reduce the risk of aggressive behavior by improving several areas of patient life that are known causes of aggression: pain, depression, lack of pleasurable activities, caregiver stress and difficulty in caregiver-patient communication.

Conditions

Dementia; Aggression; Pain

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale)

  The CMAI lists 13 behaviors (2 verbal and 11 nonverbal) and for each behavior the participant indicates how frequently the behavior occurs (1-5, higher values = greater frequency) and how disruptive the behavior is (1-5, higher values = greater disruptiveness). For any given behavior, if a participant scored a 2 or higher on BOTH frequency (i.e., it occurred "less than once a week" or more often) and disruptiveness (i.e., it was "a little" disruptive or more), he/she was considered aggressive. Overall aggression takes into account all 13 behaviors, whereas verbal aggression only pertains to two behaviors and non-verbal aggression pertains to 11 behaviors. One is considered verbally aggressive if he/she responds with a 2 or higher on both frequency and disruptiveness for either of the two verbal behaviors. One is considered non-verbally aggressive if he/she responds with a 2 or higher on both frequency and disruptiveness for any of the 11 non-verbal behaviors.

  Three Months, Six Months, Twelve Months Post Intervention

Secondary Outcomes (8)

• Caregiver-Reported Worst Pain

  Baseline, 3 months, 6 months, and 12 months

• Patient-reported Worst Pain.

  Baseline, 3, 6, and 12 months

• Caregiver Reported Overall Pain Over the Last Several Weeks

  Baseline, 3, 6, and 12 months.

• Patient-reported Overall Pain Over the Last Several Weeks

  Baseline, 3, 6, and 12 months

• Depression

  Baseline, 3, 6, and 12 months

Study Arms (2)

Arm 1: PAVeD Intervention

EXPERIMENTAL

In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.

Behavioral: PAVeD Intervention

Arm 2: Enhanced Usual Care

ACTIVE COMPARATOR

In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.

Behavioral: Enhanced Usual Care

Interventions

PAVeD Intervention BEHAVIORAL

In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.

Arm 1: PAVeD Intervention

Enhanced Usual Care BEHAVIORAL

In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing. Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain.

Arm 2: Enhanced Usual Care

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will be eligible to participate in the study if they meet the following criteria:
• have a documented diagnosis of dementia
• receive primary care from the VA
• reside outside a long-term care facility
• live within 45 minutes of the MEDVAMC
• have mild-to-moderate dementia
• have no history of aggression in the past year
• have no evidence of aggression on the CMAI at baseline (i.e., do not score 2 or higher on both frequency and disruptiveness for any of 13 behaviors listed).
• have a caregiver who is directly involved with the patient:
• at least 8 hours per week
• sees the patient at least twice a week
• and speaks English
• report clinically significant pain (either directly or through the caregiver as a proxy)

You may not qualify if:

• Patients will be excluded if they have had history of aggression in the past year
• The investigators will administer the aggression subscale of the Cohen-Mansfield Agitation Inventory (CMAI)
• Aggression will be considered present if any of the following items are endorsed as having occurred over the prior year:
• spitting
• cursing/verbal aggression
• hitting
• kicking
• grabbing
• pushing
• throwing
• biting
• scratching
• hurting self/others
• tearing things/destroying property
• making inappropriate verbal sexual advances

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

Related Publications (5)

• Fowler JH, Dannecker K, Stanley M, Wilson N, Snow AL, Kunik ME. Preventing aggression and other secondary features of dementia in elderly persons: Three case studies. Bull Menninger Clin. 2015 Spring;79(2):95-115. doi: 10.1521/bumc.2015.79.2.95.

  PMID: 26035086 RESULT

• Bradford A, Shrestha S, Snow AL, Stanley MA, Wilson N, Hersch G, Kunik ME. Managing pain to prevent aggression in people with dementia: a nonpharmacologic intervention. Am J Alzheimers Dis Other Demen. 2012 Feb;27(1):41-7. doi: 10.1177/1533317512439795.

  PMID: 22467413 RESULT

• Breland JY, Barrera TL, Snow AL, Sansgiry S, Stanley MA, Wilson N, Amspoker AB, Kunik ME. Correlates of pain intensity in community-dwelling individuals with mild to moderate dementia. Am J Alzheimers Dis Other Demen. 2015 May;30(3):320-5. doi: 10.1177/1533317514545827. Epub 2014 Aug 7.

  PMID: 25107934 RESULT

• Li J, Snow AL, Wilson N, Stanley MA, Morgan RO, Sansgiry S, Kunik ME. The Quality of Pain Treatment in Community-Dwelling Persons with Dementia. Dement Geriatr Cogn Dis Extra. 2015 Dec 5;5(3):459-70. doi: 10.1159/000441717. eCollection 2015 Sep-Dec.

  PMID: 26955380 RESULT

• Amspoker AB, Snow AL, Renn BN, Block P, Pickens S, Morgan RO, Kunik ME. Patient Versus Informal Caregiver Proxy Reports of Pain Interference in Persons With Dementia. J Appl Gerontol. 2021 Apr;40(4):414-422. doi: 10.1177/0733464820902632. Epub 2020 Feb 6.

  PMID: 32026743 DERIVED

MeSH Terms

Conditions

Dementia; Aggression; Pain

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Mark Kunik, MD, MPH
• Organization: Houston Center for Innovations in Quality, Effectiveness, and Safety

kunik.marke@va.gov

713-794-8639

Study Officials

• Mark E. Kunik, MD MPH

  Michael E. DeBakey VA Medical Center, Houston, TX

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2011
• First Posted: March 30, 2011
• Study Start: May 1, 2011
• Primary Completion: February 1, 2015
• Study Completion: September 1, 2015
• Last Updated: June 24, 2016
• Results First Posted: May 19, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)