NCT01325714

Preventing Aggression in Veterans With Dementia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 203 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dementia
• Aggression
• Pain

Interventions

Type	Name	Description
BEHAVIORAL	PAVeD Intervention	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.
BEHAVIORAL	Enhanced Usual Care	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.

Timeline

• Start date: 2011-05-01
• Primary completion: 2015-02-01
• Completion: 2015-09-01
• First posted: 2011-03-30
• Last updated: 2016-06-24
• Results posted: 2016-05-19

Locations

1 site across 1 country: United States