Preventing Aggression in Veterans With Dementia (PAVeD)

VA Office of Research and Development

Status and phase: Completed; Phase 3

Conditions: Aggression; Pain; Dementia

Treatments: Behavioral: Enhanced Usual Care; Behavioral: PAVeD Intervention

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01325714

IIR 09-351

Details and patient eligibility

About

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.

Full 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.

Enrollment: 203 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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203 participants in 2 patient groups

Arm 1: PAVeD Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: PAVeD Intervention

Arm 2: Enhanced Usual Care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Enhanced Usual Care