Preventing Aggression in Veterans With Dementia (PAVeD)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01325714
First received: March 28, 2011
Last updated: August 28, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Dementia
Aggression
Pain
Behavioral: PAVeD Intervention
Behavioral: Enhanced Usual Care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Preventing Aggression in Veterans With Dementia

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Cohen-Mansfield Agitation Inventory (aggression subscale) [ Time Frame: Three Months, Six Months, Twelve Months Post Intervention ] [ Designated as safety issue: No ]
    Incidence of aggression


Estimated Enrollment: 220
Study Start Date: May 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
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
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.
Active Comparator: Arm 2
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

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.


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. We 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

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 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

  • We 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01325714

Locations
United States, Texas
Michael E DeBakey VA Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
Principal Investigator: Mark E. Kunik, MD MPH Michael E DeBakey VA Medical Center
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01325714     History of Changes
Other Study ID Numbers: IIR 09-351
Study First Received: March 28, 2011
Last Updated: August 28, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Dementia
Aggression
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on October 01, 2014