Clinical Trial: Preventing Aggression in Veterans With Dementia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Preventing Aggression in Veterans With Dementia

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 Summary: 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.
Sponsor: VA Office of Research and Development

Current Primary Outcome: 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 ]

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.



Original Primary Outcome: Cohen-Mansfield Agitation Inventory (Aggression Subscale) [ Time Frame: Three Months, Six Months, Twelve Months Post Intervention ]

Current Secondary Outcome:

  • Caregiver-Reported Worst Pain [ Time Frame: Baseline, 3 months, 6 months, and 12 months ]

    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 ]

    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. ]

    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 ]

    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 ]

    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 ]

    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 ]

    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 ]

    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.



Original Secondary Outcome:

Information By: VA Office of Research and Development

Dates:
Date Received: March 28, 2011
Date Started: May 2011
Date Completion:
Last Updated: May 19, 2016
Last Verified: May 2016