Clinical trial NCT01325714: Preventing Aggression in Veterans With Dementia
Official title: Preventing Aggression in Veterans With Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dementia
Aggression
Pain
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2011-03-30
Enrollment: 203
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: Dementia is known primarily for its effects on memory, however, eighty percent of persons with dementia also have behavioral disturbances. This is often not addressed, leading to increased use of nursing homes, higher incidence of injury (both patient and caregiver) and the use of tranquilizing medications. Pain is one of the strongest predictors of aggression. The prevalence of pain in persons with dementia is known to be about 50%. Untreated pain is associated with significant negative outcomes, including increased health care use, inactivity and isolation. The investigators aim to determine whether outcome differences exist between active intervention and control conditions in relation to the occurrence of aggressive behavior, pain and depression, and its impact on pleasant activities, caregiver burden, quality of caregiver-patient relationship, antipsychotic use, health-service use, injuries to patient and caregiver, and nursing home placement. The active intervention, Preventing Aggression in Veterans with Dementia (PAVeD), is a family caregiver-focused, home-based intervention that uses psychoeducational and behavioral approaches to help reduce the risk of aggressive behavior in persons with dementia. The objective of PAVeD is to improve several areas of patient life that are known causes of aggression: pain and distress (including mood problems), lack of pleasurable activities, and difficulty in patient-caregiver communication that may negatively affect relationship quality and caregivers' recognition of pain.

Eligibility criteria: Inclusion Criteria:

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)

Exclusion Criteria:

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
  * or making inappropriate physical sexual advances

Participants that scored 2 or higher for both frequency and disruptiveness on any of the 13 behaviors listed on the CMAI at baseline were considered aggressive and were excluded from the study.

Primary outcomes:
measure: Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale)
timeFrame: Three Months, Six Months, Twelve Months Post Intervention
Secondary outcomes:
measure: Caregiver-Reported Worst Pain
timeFrame: Baseline, 3 months, 6 months, and 12 months
measure: Patient-reported Worst Pain.
timeFrame: Baseline, 3, 6, and 12 months
measure: Caregiver Reported Overall Pain Over the Last Several Weeks
timeFrame: Baseline, 3, 6, and 12 months.
measure: Patient-reported Overall Pain Over the Last Several Weeks
timeFrame: Baseline, 3, 6, and 12 months
measure: Depression
timeFrame: Baseline, 3, 6, and 12 months
measure: Pleasant Events - Short Form - Alzheimer's Disease
timeFrame: Baseline, 0, 3, 6, 12 months
measure: Caregiver Burden
timeFrame: Baseline, 3, 6, 12 months
measure: Caregiver-perceived Mutuality
timeFrame: Baseline, 3, 6, 12 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
Study officials:
affiliation: Michael E. DeBakey VA Medical Center, Houston, TX
name: Mark E. Kunik, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.