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Preventing Aggression in Veterans With Dementia (PAVeD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01325714
First received: March 28, 2011
Last updated: May 19, 2016
Last verified: May 2016
  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 VA Office of Research and Development:

Primary Outcome Measures:
  • Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale) [ Time Frame: Three Months, Six Months, Twelve Months Post Intervention ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Caregiver-Reported Worst Pain [ Time Frame: Baseline, 3 months, 6 months, and 12 months ] [ Designated as safety issue: No ]

    This is one item on the Philadelphia Pain Intensity Scale. One item with scores from 0 to 5, where 0 = no pain, 1 = little pain, 2 = moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable.

    Higher scores = greater pain severity


  • Patient-reported Worst Pain. [ Time Frame: Baseline, 3, 6, and 12 months ] [ Designated as safety issue: No ]

    This is one item on the Philadelphia Pain Intensity Scale. One item on a 0-5 scale, where 0 = no pain, 1 = little pain, 2= moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable.

    Higher scores = greater pain severity.


  • Caregiver Reported Overall Pain Over the Last Several Weeks [ Time Frame: Baseline, 3, 6, and 12 months. ] [ Designated as safety issue: No ]

    This is one item on the Philadelphia Pain Intensity Scale. One item on a 0-5 scale, where 0 = no pain, 1 = little pain, 2= moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable.

    Higher scores = greater pain severity.


  • Patient-reported Overall Pain Over the Last Several Weeks [ Time Frame: Baseline, 3, 6, and 12 months ] [ Designated as safety issue: No ]

    This is one item on the Philadelphia Pain Intensity Scale. One item on a 0-5 scale, where 0 = no pain, 1 = little pain, 2= moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable.

    Higher scores = greater pain severity.


  • Depression [ Time Frame: Baseline, 3, 6, and 12 months ] [ Designated as safety issue: No ]

    Geriatric Depression Scale. 30 item scale with response options of yes = 1 and no = 0 to each item.

    Total GDS scores range from 0 to 30, with greater scores indicating greater depression.


  • Pleasant Events - Short Form - Alzheimer's Disease [ Time Frame: Baseline, 0, 3, 6, 12 months ] [ Designated as safety issue: No ]

    The frequency of engagement in pleasant events, according to the Pleasant Events Schedule - Alzheimer's Disease.

    For each of 20 events, participants answered the frequency (0 = not at all, 1 = 1-6 times, 2 = 7+ times) they engaged in the event and whether they enjoyed the event (1 = yes, 0 = no).

    For each item, frequency x enjoyment were multiplied. Then scores for each of the 20 items were added together.

    The possible range of scores on the PES frequency of engagement in pleasant events is from 0 - 40, with higher scores indicating more frequent engagement in pleasant events.


  • Caregiver Burden [ Time Frame: Baseline, 3, 6, 12 months ] [ Designated as safety issue: No ]

    Caregiver-reported burden, according to the Burden Inventory. 22 items are responded to on a 0-4 scale where 0 = never, 1 = rarely, 2 = sometimes, 3 = quite frequently, and 4 = nearly always.

    Scores are then summed so that the total range is from 0 to 88. Higher scores indicate greater caregiver burden.


  • Caregiver-perceived Mutuality [ Time Frame: Baseline, 3, 6, 12 months ] [ Designated as safety issue: No ]

    Caregiver-Perceived Total Mutuality (with patient), based on the Mutuality Scale.

    Fifteen items about the caregivers' relationship with the patient with dementia were responded to on a 0-4 scale, where 0 = not at all, 1 = a little, 2 = some, 3 = quite a bit, and 4 = a great deal.

    responses to all 15 items were averaged, so total scores range from 0-4, with higher values indicating greater mutuality.



Enrollment: 203
Study Start Date: May 2011
Study Completion Date: September 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: PAVeD Intervention
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: Enhanced Usual Care
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. 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

Ages Eligible for Study:   60 Years and older   (Adult, Senior)
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 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.

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

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01325714     History of Changes
Other Study ID Numbers: IIR 09-351 
Study First Received: March 28, 2011
Results First Received: March 25, 2016
Last Updated: May 19, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Dementia
Aggression
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 26, 2016